Gi Functional Dearangements

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8 Κλινικό Θέμα Κλινικό Θέμα Κλινικό σενάριο Γυναίκα 30 ετών προσέρχεται στο ιατρείο σας αναφέ- ροντας από έτους, διαλείπον, διαξιφιστικό άλγος δεξιού υποχονδρίου, με ταυτόχρονη εμφάνιση ναυτίας και ενίο- τε εμέτου. Η διάρκεια του πόνου ποικίλει από 30΄ έως 2 ώρες, αντανακλά στη δεξιά ωμική άρθρωση και δε συνδέ- εται με τις κενώσεις ή τη φυσική άσκηση. Σε επανειλημ- μένες επισκέψεις της ασθενούς στα επείγοντα περιστατι- κά, ο αιματολογικός έλεγχος (ηπατική βιοχημεία, αμυλά- ση κ.λπ.) καθώς και το υπερηχοτομογράφημα άνω κοιλί- ας ήταν φυσιολογικά. Πρόσφατη ενδοσκόπηση ανωτέρου πεπτικού δεν ανέδειξε παθολογία. Το πρόβλημα Φυσιολογικό υπερηχοτομογράφημα και αιματολογικός έλεγχος. Προέρχεται το άλγος από τα χοληφόρα; Ίσως πρόκειται για αλιθιασική χολοκυστοπάθεια αφού αποκλει- σθούν πρώτα το πεπτικό έλκος, η χοληδοχολιθίαση και μικρολιθίαση, οι νεοπλασίες χοληφόρων και παγκρέατος, το ευερέθιστο έντερο και το μυοσκελετικό άλγος. Η παθοφυσιολογία της αλιθιασικής χολοκυστοπάθειας δεν είναι πλήρως κατανοητή. Πιθανές θεωρίες είναι η πα- ρεμπόδιση στη ροή της χολής από τη χοληδόχο κύστη, δι- αταραχές κινητικότητας αυτής, έλλειψη συντονισμού με- ταξύ χοληδόχου κύστεως και σφιγκτήρα του Οddi και, τέ- λος, η σπλαγχνική υπερευαισθησία. Διαταραχή κινητικότητας της χοληδόχου παρατηρείται μετά από εναπόθεση κρυστάλλων χοληστερόλης επί του τοιχώματός της, ασθενής ανταπόκριση στη χολοκυστοκι- νίνη (CCK) και, τέλος, συγγενείς ανωμαλίες αυτής. Ο ρό- λος της σπλαγχνικής υπερευαισθησίας είναι εξίσου σημα- ντικός, όπως και στις υπόλοιπες λειτουργικές διαταραχές του πεπτικού συστήματος. Η συμπτωματολογία Προεξέχον σύμπτωμα στη δυσκινησία των χοληφόρων εί- ναι το εντοπισμένο άλγος στο δεξιό υποχόνδριο. Τα χα- ρακτηριστικά του έχουν καθοριστεί από τα κριτήρια Ρώ- μης ΙΙΙ. Ο πόνος είναι διαλείπων, αντανακλά στη δεξιά ωμι- κή άρθρωση ή την πλάτη, συχνά συνοδεύεται από ναυτία ή έμετο και συνήθως είναι μεταγευματικός. Ίκτερος ή πυρετός δεν υπάρχουν και η κλινική εξέταση εί- ναι συνήθως χωρίς ευρήματα εκτός από κάποια ήπια ευαι- σθησία κατά την ψηλάφηση του δεξιού υποχονδρίου. Διαγνωστική προσπέλαση Διαγνωστικά εργαλεία πρώτης γραμμής, η γαστροσκόπη- ση, η MRCP, και το EUS με τη γνωστή ειδικότητα και ευαι- σθησία που τα διακρίνει. Στο πρόσφατο παρελθόν μια σειρά δοκιμασιών μάς έδι- νε τη δυνατότητα εκτίμησης της συσπαστικής λειτουργί- ας της χοληδόχου κύστεως. Όπως η αναπαραγωγή πόνου μετά από χορήγηση CCK, η χολοκυστογραφία με CCK, η διενέργεια υπερηχοτομογραφήματος, και η μέτρηση του όγκου της χοληδόχου με παράλληλη χορήγηση CCK ή γεύματος. Παρόλα αυτά, η άμεση εξάρτηση του αποτε- λέσματος από τον εκτελούντα την εξέταση, καθώς και η χαμηλή ευαισθησία και ειδικότητα που διαθέτουν τις καθι- στούν πλέον μη αξιόπιστες. Η πλέον χρησιμοποιούμενη δοκιμασία για τη διάγνωση της αλιθιασικής χολοκυστοπάθειας είναι το σπινθηρογράφη- μα χοληφόρων ( 99m technetium- labeled hepatoiminodiacetic Άλγος Δεξιού Υποχονδρίου και Φυσιολογικό Υπερηχοτομογράφημα Ελεύθερη μετάφραση και επιμέλεια: Κων/νος Ι. Ζωγράφος endo_no12 c.indd 8 13/5/2009 3:30:07 μμ

Transcript of Gi Functional Dearangements

Page 1: Gi Functional Dearangements

8

Κλινικό Θέμα

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Κλινικό σενάριοΓυναίκα 30 ετών προσέρχεται στο ιατρείο σας αναφέ-ροντας από έτους, διαλείπον, διαξιφιστικό άλγος δεξιού υποχονδρίου, με ταυτόχρονη εμφάνιση ναυτίας και ενίο-τε εμέτου. Η διάρκεια του πόνου ποικίλει από 30΄ έως 2 ώρες, αντανακλά στη δεξιά ωμική άρθρωση και δε συνδέ-εται με τις κενώσεις ή τη φυσική άσκηση. Σε επανειλημ-μένες επισκέψεις της ασθενούς στα επείγοντα περιστατι-κά, ο αιματολογικός έλεγχος (ηπατική βιοχημεία, αμυλά-ση κ.λπ.) καθώς και το υπερηχοτομογράφημα άνω κοιλί-ας ήταν φυσιολογικά. Πρόσφατη ενδοσκόπηση ανωτέρου πεπτικού δεν ανέδειξε παθολογία.

Το πρόβλημα Φυσιολογικό υπερηχοτομογράφημα και αιματολογικός έλεγχος. Προέρχεται το άλγος από τα χοληφόρα; Ίσως πρόκειται για αλιθιασική χολοκυστοπάθεια αφού αποκλει-σθούν πρώτα το πεπτικό έλκος, η χοληδοχολιθίαση και μικρολιθίαση, οι νεοπλασίες χοληφόρων και παγκρέατος, το ευερέθιστο έντερο και το μυοσκελετικό άλγος.

Η παθοφυσιολογία της αλιθιασικής χολοκυστοπάθειας δεν είναι πλήρως κατανοητή. Πιθανές θεωρίες είναι η πα-ρεμπόδιση στη ροή της χολής από τη χοληδόχο κύστη, δι-αταραχές κινητικότητας αυτής, έλλειψη συντονισμού με-ταξύ χοληδόχου κύστεως και σφιγκτήρα του Οddi και, τέ-λος, η σπλαγχνική υπερευαισθησία.

Διαταραχή κινητικότητας της χοληδόχου παρατηρείται μετά από εναπόθεση κρυστάλλων χοληστερόλης επί του τοιχώματός της, ασθενής ανταπόκριση στη χολοκυστοκι-νίνη (CCK) και, τέλος, συγγενείς ανωμαλίες αυτής. Ο ρό-λος της σπλαγχνικής υπερευαισθησίας είναι εξίσου σημα-

ντικός, όπως και στις υπόλοιπες λειτουργικές διαταραχές του πεπτικού συστήματος.

Η συμπτωματολογία Προεξέχον σύμπτωμα στη δυσκινησία των χοληφόρων εί-ναι το εντοπισμένο άλγος στο δεξιό υποχόνδριο. Τα χα-ρακτηριστικά του έχουν καθοριστεί από τα κριτήρια Ρώ-μης ΙΙΙ. Ο πόνος είναι διαλείπων, αντανακλά στη δεξιά ωμι-κή άρθρωση ή την πλάτη, συχνά συνοδεύεται από ναυτία ή έμετο και συνήθως είναι μεταγευματικός.

Ίκτερος ή πυρετός δεν υπάρχουν και η κλινική εξέταση εί-ναι συνήθως χωρίς ευρήματα εκτός από κάποια ήπια ευαι-σθησία κατά την ψηλάφηση του δεξιού υποχονδρίου.

Διαγνωστική προσπέλασηΔιαγνωστικά εργαλεία πρώτης γραμμής, η γαστροσκόπη-ση, η MRCP, και το EUS με τη γνωστή ειδικότητα και ευαι-σθησία που τα διακρίνει.

Στο πρόσφατο παρελθόν μια σειρά δοκιμασιών μάς έδι-νε τη δυνατότητα εκτίμησης της συσπαστικής λειτουργί-ας της χοληδόχου κύστεως. Όπως η αναπαραγωγή πόνου μετά από χορήγηση CCK, η χολοκυστογραφία με CCK, η διενέργεια υπερηχοτομογραφήματος, και η μέτρηση του όγκου της χοληδόχου με παράλληλη χορήγηση CCK ή γεύματος. Παρόλα αυτά, η άμεση εξάρτηση του αποτε-λέσματος από τον εκτελούντα την εξέταση, καθώς και η χαμηλή ευαισθησία και ειδικότητα που διαθέτουν τις καθι-στούν πλέον μη αξιόπιστες.

Η πλέον χρησιμοποιούμενη δοκιμασία για τη διάγνωση της αλιθιασικής χολοκυστοπάθειας είναι το σπινθηρογράφη-μα χοληφόρων (99mtechnetium- labeled hepatoiminodiacetic

Άλγος Δεξιού Υποχονδρίου και Φυσιολογικό Υπερηχοτομογράφημα

Ελεύθερη μετάφραση και επιμέλεια: Κων/νος Ι. Ζωγράφος

endo_no12 c.indd 8 13/5/2009 3:30:07 µµ

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acid, 99mHIDA). Το iminodiacetic acid προσλαμβάνεται από το ήπαρ και απεκκρίνεται με τη χολή. Το κλάσμα εξώθησης της χοληδόχου κύστης εκτιμάται μετά από χορήγηση CCK, ενώ ο βαθμός κένωσης εξαρτάται από τη δόση και το ρυθ-μό χορήγησης. Χαμηλό κλάσμα εξώθησης είναι ενδεικτικό δυσλειτουργίας. Ορισμένοι ασθενείς εμφανίζουν αναπαρα-γωγή των συμπτωμάτων κατά τη διάρκεια της δοκιμασίας, και αυτό αποτελεί προγνωστικό στοιχείο για καλή ανταπό-κριση στην πιθανή χολοκυστεκτομή. Όταν η HIDA επιβε-βαιώσει τη δυσλειτουργία της χοληδόχου η χειρουργική αντιμετώπιση είναι πολύ πιθανή. Εκτιμάται, ότι τις δύο τε-λευταίες δεκαετίες η αύξηση του αριθμού των χολοκυστε-κτομών ίσως οφείλεται στις αυξανόμε-νες θετικές δοκιμασίες. Αρκετές μελέ-τες προσπάθησαν να αναδείξουν τα πιθανά οφέλη μιας τέτοιας απόφασης εκ μέρους του θεράποντος ιατρού, αλλά η αναδρομικότητα των μελετών καθώς και ο μικρός αριθμός των συμ-μετεχόντων ασθενών καθιστά τα απο-τελέσματά τους χαμηλής αξιοπιστί-ας. Όμως μια προοπτική μελέτη των Yap et al ξεκάθαρα υποστηρίζει τη χει-ρουργική αντιμετώπιση του προβλή-ματος. Ασθενείς με θετική HIDA για αλιθιασική χολοκυστοπάθεια (κλάσμα εξώθησης < 40%) διακρίθηκαν σε δυο υποομάδες, χειρουργηθέντες (n =11) και μη (n = 10). Χρόνος παρακολού-θησης 34 μήνες. Από την πρώτη ομά-δα 10 είχαν πλήρη ύφεση συμπτωμά-των, και 1 μερική^ εν αντιθέσει, όλοι οι ασθενείς της δεύτερης ομάδας παρέ-μειναν συμπτωματικοί, και 2 χειρουργήθηκαν.

Οι Ponsky και συνεργάτες σε μια μετα-ανάλυση 5 μελε-τών που αφορούσαν 274 ασθενείς με αλιθιασική χολοκυ-στοπάθεια (θετική HIDA) αξιολόγησαν τα οφέλη της χει-ρουργικής θεραπείας. Βελτίωση των συμπτωμάτων εμφά-νισε το 98% των χειρουργηθέντων εν αντιθέσει με το 32% από την ομάδα εκείνων που αντιμετωπίστηκαν συντηρητι-κά. Πλήρη ύφεση εμφάνισαν το 74% και 8% αντίστοιχα.

ΑΜΦΙΒΟΛΙΕΣ…Παρά την ευρεία χρήση της χολοκυστογραφίας για τη δι-άγνωση της αλιθιασικής χολοκυστοπάθειας υπάρχουν αρ-κετά αδιευκρίνιστα σημεία για τη διαδικασία εκτέλεσης της δοκιμασίας τα οποία μειώνουν την αξιοπιστία της. Οι μετρήσεις του κλάσματος εξώθησης της χοληδόχου επη-ρεάζονται άμεσα από τη δόση, το ρυθμό και τη διάρκεια χορήγησης της CCK. Τυποποιημένος τρόπος διενέργειας της δοκιμασίας, κοινά αποδεκτός, δεν περιγράφεται. Οι κατευθυντήριες γραμμές της Εταιρείας Πυρηνικής Ιατρι-κής δεν αναφέρουν καμία συγκεκριμένη δόση ή διάρκεια χορήγησης της CCK. Στις οδηγίες χρήσης του εμπορικού προϊόντος Kinevac (sincalide), μια μορφή συνθετικής CCK, αναφέρονται τρεις διαφορετικοί τρόποι χορήγησης!!!

Ίσως η πιο αξιόπιστη διαδικασία είναι εκείνη την οποία πε-ριγράφουν οι Krishnamurthy και συνεργάτες, κατά τους οποίους η χορήγηση είναι 3΄ σε διάστημα 30΄και 60΄.

Η απουσία, λοιπόν, προτύπου τρόπου εκτέλεσης της δο-κιμασίας έχει σαν αποτέλεσμα τη μη κοινά αποδεκτή και ίσως τη λανθασμένη αξιολόγηση του αποτελέσματος. Οι περισσότερες δημοσιεύσεις για την εκτίμηση των αποτε-λεσμάτων αναφέρουν παρουσία δυσλειτουργίας όταν το κλάσμα εξώθησης της χοληδόχου είναι <35-40%. Επίσης υπερσυσταλτικότητα της χοληδόχου (>85%) μπορεί να προκαλέσει αναπαραγωγή παρόμοιων συμπτωμάτων.

Η ειδικότητα της χολοκυστογραφίας για τη διάγνωση της δυσλειτουργίας της χοληδόχου δεν εί-ναι 100%. Αρκετές άλλες νοσολογικές οντότητες όπως η παχυσαρκία, ο σακ-χαρώδης διαβήτης, η κύηση, η κοιλιο-κάκη, καθώς και λήψη φαρμάκων (ανα-στολείς διαύλων ασβεστίου, οπιοειδή, αντιχολινεργικά) μπορούν να προκαλέ-σουν παρόμοια εικόνα.

ΜΕΤΑ ΤΗ ΧΟΛΟΚΥΣΤΕΚΤΟΜΗ…Παρά την ΄΄θετικά προσκείμενη΄΄ βι-βλιογραφία ως προς τη θεραπευτι-κή αποτελεσματικότητα της χολοκυ-στεκτομής, υπάρχουν ακόμη αρκετά αναπάντητα ερωτήματα. Οι ασθενείς με δυσλειτουργία της χοληδόχου έχουν μερική και όχι πλήρη ύφεση των συμπτωμάτων μετά το χειρουρ-γείο. Οι λόγοι παραμένουν αδιευκρί-

νιστοι, αλλά πιθανότατα να υπάρχει άλλη γενεσιουρ-γός αιτία ή η δυσλειτουργία της χοληδόχου να αποτε-λεί στοιχείο ενός πολυπαραγοντικού συνδρόμου. Υπάρ-χουν ανέκδοτες αναφορές ασθενών με φυσιολογική δο-κιμασία HIDA οι οποίοι είχαν βελτίωση των συμπτωμά-των τους μετά τη χολοκυστεκτομή καθώς και αρκετές μελέτες οι οποίες αποκαλύπτουν παρόμοια ανταπόκρι-ση μετά το χειρουργείο σε ασθενείς με ή χωρίς δυσλει-τουργία της χοληδόχου! Δυστυχώς δεν υπάρχουν ακό-μη ασφαλή προγνωστικά στοιχεία πιθανούς ανταπόκρι-σης στη χολοκυστεκτομή ατόμων με επιβεβαιωμένη χο-λοκυστοπάθεια. Τέλος, φαίνεται ότι ο βαθμός μείωσης της συσπαστικής ικανότητας της χοληδόχου, εκτιμώμε-νος με τη δοκιμασία HIDA, δε συνδέεται απαραίτητα με καλύτερη βελτίωση των συμπτωμάτων μετά το χειρουρ-γείο.

Η μακροχρόνια διατήρηση της ανταπόκρισης ίσως είναι ελλιπώς μελετημένη. Το χρονικό διάστημα μελέτης που αναφέρεται στις περισσότερες μελέτες, συμπεριλαμβα-νομένης και του Ponsky, ποικίλει από 9-30 μήνες. Μια μελέτη παιδιατρικών ασθενών, με χαμηλό κλάσμα εξώ-θησης, οι οποίοι υποβλήθηκαν σε χολοκυστεκτομή, 1 μήνα μετά είχαν υψηλά ποσοστά ανταπόκρισης. Όμως

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Παρά την ευρεία χρήση της χολοκυστογραφίας

για τη διάγνωση της αλιθιασικής

χολοκυστοπάθειας υπάρχουν αρκετά

αδιευκρίνιστα σημεία για τη διαδικασία

εκτέλεσης της δοκιμασίας τα οποία

μειώνουν την αξιοπιστία της

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μετά από 2ετή παρακολούθηση τα ποσοστά των ασθε-νών οι οποίοι παρέμεναν ασυμπτωματικοί ήταν παρόμοια με εκείνα που αντιμετωπίστηκαν συντηρητικά. Η φυσι-κή εξέλιξη της δυσλειτουργίας της χοληδόχου παραμέ-νει άγνωστη. Παρόλα αυτά σε μια μελέτη αναφέρεται ότι ασθενείς με επιβεβαιωμένη δυσλειτουργία (χαμηλό κλά-σμα εξώθησης στη δοκιμασία HIDA), εάν υποβληθούν σε εκ νέου δοκιμασία μετά από μήνες ή χρόνια, η δυσλει-τουργία παραμένει.

ΔΥΣΛΕΙΤΟΥΡΓΙΑ ΣΦΙΓΚΤΗΡΑ ΤΟΥ ODDIΗ Δυσλειτουργία του Σφιγκτήρα του Οddi (ΔΣΟ) δυνητι-κά αποτελεί άλλη μια αιτία εμφάνισης άλγους στην περιο-χή της άνω κοιλίας. Τυπικά εμφανίζεται μετά από χολοκυ-στεκτομή, εντοπίζεται στο δεξιό υποχόνδριο, έχοντας συ-νεχή ή κολικοειδή χαρακτήρα. Αρκετά είναι τα ερωτήματα τα οποία παραμένουν αναπάντητα, και αφορούν τη σχέση ΔΣΟ και δυσλειτουργίας της χοληδόχου: (1) εμφανίζεται η ΔΣΟ σε ασθενείς με άθικτη χοληδόχο κύστη (2) υπάρχει σχέση μεταξύ ΔΣΟ και δυσλειτουργίας της χοληδόχου και (3) ποιος είναι ο ρόλος της ΔΣΟ και της λανθάνουσας δυ-σλειτουργίας της χοληδόχου, στην αξιολόγηση και το χει-ρισμό ασθενών με άλγος δεξιού υποχονδρίου και φυσιο-λογικό υπερηχοτομογράφημα;

Υπάρχουν περιορισμένες αναφορές για τη συχνότητα εμφάνισης ΔΣΟ σε ασθενείς με άθικτη χοληδόχο. Παρό-λα αυτά ΔΣΟ έχει πιστοποιηθεί στο 10% ασθενών με συ-μπτωματική χολολιθίαση και στο 50% σε ασθενείς με άλ-γος δεξιού υποχονδρίου και φυσιολογικό υπερηχοτομο-γράφημα. Παραμένει άγνωστο εάν υπάρχει συσχέτιση μεταξύ υπερτονίας του Oddi και δυσλειτουργίας της χο-ληδόχου. Σε μια αναδρομική μελέτη, στην οποία συμμε-τείχαν 81 ασθενείς με άλγος δεξιού υπο-χονδρίου και φυσιολογική χοληδόχο στο υπερηχοτομογράφημα υποβλήθηκαν σε μανομετρία του Oddi και σε δοκιμασία HIDA. Στους 41 ασθενείς με φυσιολογική HIDA το 57% είχαν ΔΣΟ, ενώ στους 40 με παθολογική HIDA 50% είχαν ΔΣΟ. Συμπε-ρασματικά, σε αυτή την ομάδα των ασθε-νών, η ΔΣΟ και η δυσλειτουργία της χο-ληδόχου μπορεί να εμφανιστούν ταυτό-χρονα ή ανεξάρτητα η μια από την άλλη.

Ασθενείς με άλγος δεξιού υποχονδρίου, και, φυσιολογικό υπερηχοτομογράφημα, ηπατικά ένζυμα, αμυλάση και λιπάση δυ-νητικά μπορεί να εμφανίσουν ΔΣΟ. Αξιο-λογώντας έναν ασθενή χωρίς αντικειμενι-κά στοιχεία χολοπαγκρεατικής νόσου και με ακέραια τη χοληδόχο κύστη, το ερώτη-μα που γεννάται είναι κατά πόσον η δια-γνωστική/ θεραπευτική προσέγγιση θα εί-ναι συντηρητική ή θα πρέπει να προχωρή-σουμε σε περαιτέρω διαγνωστικά και θε-ραπευτικά μέσα επεμβατικού χαρακτήρα. Η διάγνωση δυσλειτουργίας της χοληδό-

χου γίνεται βάσει του αποτελέσματος της αναίμακτης HIDA. Επομένως, σε ασθενή με ακέραια χοληδόχο, η δι-άγνωση της αλιθιασικής χολοκυστοπάθειας προηγείται της ΔΣΟ, θέτοντας έτσι την απόφαση διενέργειας ERCP και παράλληλης μανομετρίας (εξετάσεις υψηλής επικιν-δυνότητας) σε δεύτερο χρόνο. Ακόμη και σε κέντρα ανα-φοράς, ο κίνδυνος εμφάνισης επιπλοκών (λοιμώξεις, αι-μορραγία, διάτρηση, παγκρεατίτιδα) με συνοδό νοση-λεία, μετά από διενέργεια ERCP/ μανομετρίας ανέρχε-ται σε 10-15%. Περιορισμένες αναφορές, αναδρομικού υλικού, που αφορούν τα αποτελέσματα σφιγκτηροτομής σε ασθενείς με ΔΣΟ, περιγράφουν ύφεση του άλγους σε ποσοστά 40-70%.

Σε ασθενή με φυσιολογικό κλάσμα εξώθησης χοληδόχου κύστης, μετά από δοκιμασία HIDA, η απόφαση της εμπει-ρικής χολοκυστεκτομής ή της ERCP, θα πρέπει να λαμβά-νεται μετά από λεπτομερή ενημέρωση του ασθενούς για τους κινδύνους και τα οφέλη αυτών.

ΔΗΜΟΣΙΕΥΜΕΝΕΣ ΚΑΤΕΥΘΥΝΤΗΡΙΕΣ ΓΡΑΜΜΕΣΗ διάσκεψη Ρώμης ΙΙΙ περιγράφει και αποσαφηνίζει τα δι-αγνωστικά κριτήρια για τις λειτουργικές διαταραχές της χοληδόχου, αλλά δεν προβαίνει σε κατευθυντήριες γραμ-μές για το χειρισμό αυτών των ασθενών. Η Εταιρεία Χει-ρουργικής Πεπτικού Συστήματος, στις κατευθυντήρι-ες γραμμές που ανακοίνωσε το 2006 για τη θεραπευτι-κή αντιμετώπιση ασθενών με χολολιθίαση ή χολοκυστοπά-θεια, συστήνει χολοκυστεκτομή σε ασθενείς με υποτροπι-άζοντα επεισόδια άλγους προέλευσης χοληφόρων, επιβε-βαιωμένη με χολοκυστογραφία, οριοθετώντας παθολογι-κό κλάσμα εξώθησης χοληδόχου <30%. n

Αλγόριθμος διαγνωστικής προσπέλασης άλγους δεξιού υποχονδρίου(Πηγή: Clin Gastroenterol Hepatol 2008 AGA Institute)

Συντηρητική θεραπεία

Άλγος δεξιού υποχονδρίου και φυσιολογικό U/S

ΦυσιολογικάΠαθολογικά

Ηπατικά ένζυμα και αμυλάση

Φυσιολογική

Δοκιμασία HIDAΠεραιτέρω διερεύνηση

Παθολογική

ERCP&

Μανομετρία

Χολοκυστεκτομή

Επιμονή/υποτροπήσυμπτωμάτων

Ύφεση συμπτωμάτων

endo_no12 c.indd 10 13/5/2009 3:30:08 µµ

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Ï äñüìïò ãéá ôç Ñþìç óõíÝ÷éóå ôçí ðïñåßá ôïõ ôáîéäåýïíôáò ÄõôéêÜ óôï Los Angeles ôçò Êáëéöüñíéá, ôïí ÌÜéï ôïõ 2006 ãéá íá áðïêáëýøåé ôá íÝá, áíáèåùñçìÝíá êñéôÞñéá óôï åôÞ-óéï DDW. Óôï ßäñõìá Ñþìçò óõììå-ôÝ÷ïõí ðÜíù áðü 100 äéåèíåßò åéäéêïß óå èÝìáôá ëåéôïõñãéêþí äéáôáñá÷þí ôïõ ãáóôñåíôåñéêïý óõóôÞìáôïò (Functional Gastrointestinal Disorders, FGID).

Ïé ìåßæïíåò áëëáãÝò ïé ïðïßåò Ýëáâáí ÷þñá óôá áíáèåùñçìÝíá êñéôÞñéá Ñþìçò ÉÉÉ, ðåñéëáìâÜíïõí:1. Åðáíáðñïóäéïñéóìü ôïõ áðáéôïý-

ìåíïõ ÷ñïíéêïý ðëáéóßïõ ãéá ôçí ðëÞñç ôáýôéóç ôïõ óõìðôþìáôïò ìå ôá äéáãíùóôéêÜ êñéôÞñéá.

2. ÁëëáãÝò óôá êñéôÞñéá ôáîéíüìçóçò (ï ìçñõêáóìüò ðëÝïí áíÞêåé óôéò ãáóôñïäùäåêáäáêôõëéêÝò ëåéôïõñ-ãéêÝò äéáôáñá÷Ýò, êáé ôï óýíäñïìï êïéëéáêïý ëåéôïõñãéêïý Üëãïõò áðïôåëåß îå÷ùñéóôÞ êáôçãïñßá êáé ü÷é ëåéôïõñãéêÞ äéáôáñá÷Þ ôïõ ðá-÷Ýïò åíôÝñïõ).

3. ÐñïóèÞêç ðáéäéáôñéêþí êáôçãïñé-þí.

4. Áîéïëüãçóç ôçò óýóôáóçò-ìïñöÞò ôùí êïðñÜíùí ãéá ôïí êáèïñéóìü ôùí õðïïìÜäùí ôïõ óõíäñüìïõ åõåñÝèéóôïõ åíôÝñïõ (äéÜññïéá Þ äõóêïéëéüôçôá).

5. Áõóôçñüôåñá êñéôÞñéá ãéá ôç äõ-óëåéôïõñãßá ôçò ÷ïëçäü÷ïõ êýóôå-ùò êáé ôïõ óöéêôÞñá ôïõ Oddi.

Óôá êñéôÞñéá Ñþìçò ÉÉÉ áíáèåùñÞèçêå åðßóçò êáé ï ïñéóìüò ôçò ëåéôïõñãéêÞò äõóðåøßáò äßíïíôáò íÝåò äéáóôÜóåéò. ¸ôóé ðëÝïí óáí ëåéôïõñãéêÞ äõóðå-øßá ïñßæåôáé, Ýíá Þ ðåñéóóüôåñá óõ-ìðôþìáôá ôá ïðïßá åìöáíßæïíôáé áðü

ôç ãáóôñïäùäåêáäáêôõëéêÞ ðåñéï-÷Þ, ðÜíôá óå áðïõóßá ïðïéáóäÞðïôå ïñãáíéêÞò, óõóôçìáôéêÞò Þ ìåôáâïëé-êÞò íüóïõ. Ôá õðüëïéðá óõìðôþìáôá ôá ïðïßá áíáöÝñïíôáí óôá êñéôÞñéá Ñþìçò ÉÉ äåí êáëýðôïíôáé ðëÝïí áðü ôçí ´´ïìðñÝëá´´ ôçò ëåéôïõñãéêÞò äõ-óðåøßáò. Åðßóçò äçìéïõñãïýíôáé äýï õðïïìÜäåò, ïìÜäá ó÷åôéæüìåíç ìå ãåýìá êáé ïìÜäá ó÷åôéæüìåíç ìå Üë-ãïò, äßíïíôáò ôéò ïíïìáóßåò óýíäñï-ìá åðéãáóôñéêïý Üëãïõò êáé ìåôáãåõ-ìáôéêü distress óýíäñïìï. Ðñïò ôï ðáñüí ôá íÝá áõôÜ óýíäñïìá ðñÝðåé íá ÷ñçóéìïðïéïýíôáé ìüíï ãéá åñåõ-íçôéêïýò óêïðïýò êáé ü÷é óôçí êëéíéêÞ ðñÜîç, ìÝ÷ñé ôçí ðëÞñç áîéïëüãçóÞ ôïõò.

Ðëçñüôçôá êáé ðñþéìïò êïñåóìüò áíôéðñïóùðåýïõí ìéá îå÷ùñéóôÞ ïìÜäá, äéáöïñåôéêÞ áðü ôç íáõôßá êáé ôïí Ýìåôï. ÕðÜñ÷ïõí ðëÝïí äýï äéáöïñåôéêÝò ïíôüôçôåò -óýíäñïìá- ôá ïðïßá êáèïñßóôçêáí óôá êñéôÞñéá Ñþìçò ÉÉÉ: ôï óýíäñïìï êõêëéêþí åìÝ-ôùí êáé ç ÷ñüíéá éäéïðáèÞò íáõôßá.

Ôþñá, üóïí áöïñÜ ôá êñéôÞñéá ôùí ëåéôïõñãéêþí äéáôáñá÷þí ôïõ ðá÷Ý-ïò åíôÝñïõ êáé ôùí õðïïìÜäùí ôïõ óõíäñüìïõ åõåñÝèéóôïõ åíôÝñïõ, ïé êõñéüôåñåò áëëáãÝò ðïõ åðéôåëÝóèç-êáí åßíáé:1. ÅéóáãùãÞ ôçò óõ÷íüôçôáò ôùí óõ-

ìðôùìÜôùí óáí ´´êáôþöëé´´ ãéá íá óõíáíôÞóïõí ôá êñéôÞñéá (ð.÷. ôñåéò ïé ðåñéóóüôåñåò çìÝñåò ôï ìÞíá ãéá ôïõò ôñåéò ôåëåõôáßïõò ìÞíåò)

2. ÄéÜñêåéá óõìðôùìÜôùí (ìåéþèçêáí ðåñéóóüôåñï áðü Ýîé ìÞíåò)

3. ÐëÞñçò äéÜêñéóç ôùí õðïïìÜäùí ôïõ åõåñÝèéóôïõ åíôÝñïõ.

Ç åðéôñïðÞ Ñþìçò ÉÉ äçìéïýñãçóå

õðïïìÜäåò ôïõ ÉÂS âáóéæüìåíç óôç óõ÷íüôçôá ôùí êåíþóåùí, ôï ó÷Þìá ôùí êïðñÜíùí êáé ôá óõìðôþìáôá êáôÜ ôçí áöüäåõóç. ¼ìùò, ëüãù ôçò ðïëõðëïêüôçôáò óôçí êëéíéêÞ ðñÜîç áëëÜ êáé ëüãù åëëåßøåùò êáëÜ ôåê-ìçñéùìÝíùí âéâëéïãñáöéêþí äåäïìÝ-íùí, ç äçìéïõñãßá-áíáèåþñçóç ôùí õðïïìÜäùí ôïõ IBS âáóßóôçêå ìüíï óôç óýóôáóç ôùí êïðñÜíùí, êÜôé ôï ïðïßï õðïóôçñßæïõí êáé ðñüóöáôåò ìåëÝôåò.

Ç íÝá ðñïôåéíüìåíç ôáîéíüìçóç ç ïðïßá âáóßóôçêå ìüíï óôç óýóôáóç ôùí êïðñÜíùí åßíáé: IBS ìå äõóêïéëé-üôçôá, IBS ìå äéÜññïéá, ìéêôü IBS êáé ÉÂS áêáèüñéóôï.

Ïé áóèåíåßò ìå ìéêôü IBS åìöáíßæïõí óêëçñÜ êáé ðïëôþäç êüðñáíá áíÜ ðåñéüäïõò ùñþí Þ çìåñþí, åíþ ïé áóèåíåßò ìå åíáëëáãÝò ôùí ´´óõíç-èåéþí´´ ôïõ åíôÝñïõ áëëÜæïõí õðï-ïìÜäá áíÜ ðåñéüäïõò åâäïìÜäùí Þ êáé ìçíþí. Ôï ó÷Þìá ôùí êïðñÜíùí êáèïñßæåôáé óýìöùíá ìå ôçí êëßìáêá Bristol óõó÷åôßæoíôÜò ôï ìå ôï ÷ñüíï äéÝëåõóÞò ôïõò áðü ôï Ýíôåñï.

Êëåßíïíôáò, ç óçìáíôéêüôåñç áëëáãÞ ç ïðïßá Ýëáâå ÷þñá óôéò ëåéôïõñãéêÝò äéáôáñá÷Ýò ôçò ÷ïëçäü÷ïõ êýóôåùò êáé ôïõ óöéãêôÞñá ôïõ Oddi, åßíáé üôé ðëÝïí, äåí áíáöÝñåôáé ãåíéêÜ óáí ëåéôïõñãéêÝò äéáôáñá÷Ýò ôùí ÷ïëç-öüñùí, áëëÜ åöåîÞò ëáìâÜíåôáé õð´ üøéí ôï áíôßóôïé÷ï áíáôïìéêü óçìåßï ãÝíåóçò ôïõ ðñïâëÞìáôïò.

Åðßóçò ï üñïò billiary- like syndrome áíáðôý÷èçêå óõíáéíåôéêÜ: 1. ¢ëãïò åíôïðéóìÝíï óôï åðéãÜóôñéï

Þ/ êáé óôï äåîéü Üíù ôåôáñôçìüñéï 2. ÕðïôñïðéÜæïíôá åðåéóüäéá åìöá-

Áðü ôç Ñþìç óôï Los Angeles ÊñéôÞñéá Ñþìçò ÉÉÉ ãéá ôéò ËåéôïõñãéêÝò Äéáôáñá÷Ýò ôïõ Ãáóôñåíôåñéêïý ÓõóôÞìáôïò

ãñÜöåé ï Êùíóôáíôßíïò ÆùãñÜöïò

Êá

ôåõè

õíôÞ

ñéåò

Ïäç

ãßåò

ÊáôåõèõíôÞñéåò Ïäçãßåò

endo_no4e.indd 24 18/4/2007 2:48:17 ìì

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íéæüìåíá óå äéáöïñåôéêÜ ÷ñïíéêÜ äéáóôÞìáôá (ü÷é êáèçìåñéíÜ)

3. Åðåéóüäéá Üëãïõò äéÜñêåéáò 30 ëå-ðôþí Þ êáé ðåñéóóüôåñï, ìå áõîá-íüìåíç Ýíôáóç (ìÝóç Þ õøçëÞ) ôá ïðïßá åðçñåÜæïõí ôçí êáèçìåñéíü-

ôçôá ôïõ áóèåíïýò Þ ôïí ïäçãïýí

óôï íïóïêïìåßï.

Åíéó÷õôéêÜ óõìðôþìáôá åßíáé åÜí ï

ðüíïò åìöáíéóôåß ìå Ýíá áðü ôá ðá-

ñáêÜôù:

1. Óõíäõáóìüò ìå íáõôßá Þ Ýìåôï 2. Áêôéíïâïëåß óôçí ðåñéï÷Þ ôçò ðëÜ-

ôçò Þ óôç äåîéÜ ùìïðëáôéáßá ÷þñá êáé

3. ÍõêôåñéíÞ áöýðíéóç.

Êá

ôåõè

õíôÞ

ñéåò

Ïäç

ãßåò

ÐÉÍÁÊÁÓ 1: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÇ ËÅÉÔÏÕÑÃÉÊÇ ÄÕÓÐÅØÉÁ

ÄéÜñêåéá óõìðôùìÜôùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, êáé ôá ïðïßá åìöáíßæïíôáé ìå Ýíá Þ ðåñéóóüôåñá áðü ôá ðáñáêÜôù:

* ÌåôáãåõìáôéêÞ ðëçñüôçôá * Åðéãáóôñéêü Üëãïò

* Ðñþéìïò êïñåóìüò * Åðéãáóôñéêüò êáýóïò

ÊÁÉ

* ÊáíÝíá óôïé÷åßï éóôéêÞò âëÜâçò (óõìðåñéëáìâáíïìÝíçò ôçò åíäïóêüðçóçò ôïõ áíùôÝñïõ ðåðôéêïý) ôï ïðïßï íá äéêáéïëïãåß ôá óõìðôþìáôá.

ÐÉÍÁÊÁÓ 2: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÅÐÉÃÁÓÔÑÉÊÏÕ ÁËÃÏÕÓ

ÄéÜñêåéá ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, ìå ÏËÁ ôá ðáñáêÜôù:

Ðüíïò êáé êáýóïò ôá ïðïßá: * ÅíáëëÜóóïíôáé

* Åíôïðßæïíôáé óôï åðéãÜóôñéï, ôïõëÜ÷éóôïí ìÝóçò åíôÜóåùò, ìéá öïñÜ ôçí åâäïìÜäá

Êáé Ï×É 1. ãåíéêåõìÝíá Þ åíôïðéóìÝíá óå Üëëç ðåñéï÷Þ ôçò êïéëßáò Þ ôïõ èþñáêá

2. íá åðÝñ÷åôáé áíáêïýöéóç ìå ôçí áöüäåõóç Þ ôçí åêôüíùóç áåñßùí

3. íá ðëçñïß ôá êñéôÞñéá ãéá äéáôáñá÷Ýò ôçò ÷ïëçäü÷ïõ êýóôçò Þ ôïõ óöéãêôÞñá ôïõ Oddi

ÐÉÍÁÊÁÓ 3: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÌÅÔÁÃÅÕÌÁÔÉÊÏ DISTRESS ÓÕÍÄÑÏÌÏ

ÔïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò 6 ôåëåõôáßïõò ìÞíåò, ìå Ýíá áðü ôá ðáñáêÜôù:

* ÌåôáãåõìáôéêÝò åíï÷ëÞóåéò 1. ïé ïðïßåò åìöáíßæïíôáé ìåôÜ áðü êáíïíéêïý ìåãÝèïõò ãåýìáôá

2. ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò ôçí åâäïìÜäá

¹

* Ðñþéìïò êïñåóìüò 1. ðïõ åìðïäßæåé ôçí ïëïêëÞñùóç åíüò êáíïíéêïý ìåãÝèïõò ãåýìáôïò

2. êáé åìöáíßæåôáé ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò ôçí åâäïìÜäá

ÊáôåõèõíôÞñéåò Ïäçãßåò

ÐÉÍÁÊÁÓ 4: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÊÕÊËÉÊÙÍ ÅÌÅÔÙÍ

ÔïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç ôïõò ôåëåõôáßïõò 6 ìÞíåò, ìå:

* ÔõðéêÜ åðåéóüäéá åìÝôùí ìå ïîåßá Ýíáñîç êáé äéÜñêåéá 1 åâäïìÜäáò ôïõëÜ÷éóôïí* 3 Þ ðåñéóóüôåñá îå÷ùñéóôÜ åðåéóüäéá ôá ðñïçãïýìåíá Ýôç* Áðïõóßá íáõôßáò êáé åìÝôùí ìåôáîý ôùí åðåéóïäßùí

Åíéó÷õôéêÜ êñéôÞñéá: Éóôïñéêü êåöáëáëãßáò, ôýðïõ çìéêñáíßáò Þ ïéêïãåíåéáêïý éóôïñéêïý çìéêñáíßáò.

ÐÉÍÁÊÁÓ 5: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÇ ×ÑÏÍÉÁ ÉÄÉÏÐÁÈÇ ÍÁÕÔÉÁ

ÄéÜñêåéá åðåéóïäßùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç 6 ìÞíåò ðñéí.

* Íáõôßá ç ïðïßá åìöáíßæåôáé ôïõëÜ÷éóôïí ìåñéêÝò öïñÝò êáôÜ ôç äéÜñêåéá ôçò åâäïìÜäáò ôïõò 3 ôåëåõôáßïõò ìÞíåò* Äåí áêïëïõèåß óõíÞèùò Ýìåôïò* Áðïõóßá ðáèïëïãéêþí åõñçìÜôùí óôçí åíäïóêüðçóç ôïõ áíùôÝñïõ ðåðôéêïý Þ ìåôáâïëéêÞò íüóïõ ç ïðïßá äéêáéïëïãåß ôç íáõôßá

ÐÉÍÁÊÁÓ 6: ÄÉÁÃÍÙÓÔÉÊÁ ÊÑÉÔÇÑÉÁ ÃÉÁ ÔÏ ÓÕÍÄÑÏÌÏ ÅÕÅÑÅÈÉÓÔÏÕ ÅÍÔÅÑÏÕ

ÄéÜñêåéá åðåéóïäßùí ôïõëÜ÷éóôïí 3 ìÞíåò, ìå Ýíáñîç 6 ìÞíåò ðñéí, áðïôåëïýìåíá áðü õðïôñïðéÜæïíôá êïéëéáêÜ Üëãç Þ äõóöïñßá**, óå óõíäõáóìü ìå äýï Þ ðåñéóóüôåñá áðü ôá áêüëïõèá:

* ¾öåóç óõìðôùìÜôùí ìå ôéò êåíþóåéò êáé /Þ* Ýíáñîç ôùí óõìðôùìÜôùí ðïõ óõíäõÜæåôáé ìå áëëáãÞ ôçò óõ÷íüôçôáò ôùí êåíþóåùí êáé /Þ* Ýíáñîç ôùí óõìðôùìÜôùí ðïõ óõíäõÜæåôáé ìå áëëáãÞ ôçò ìïñöÞò ôùí êïðñÜíùí.

** Ùò äõóöïñßá ðåñéãñÜöåôáé ç äõóÜñåóôç áßóèçóç êáé ü÷é ðüíïò

endo_no4e.indd 25 18/4/2007 2:48:18 ìì

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Appendix A

Rome III

Diagnostic

Criteria for

Functional

Gastrointestinal

Disorders

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Appendix A: Rome III Diagnostic Criteria for FGIDs

A. Functional Esophageal Disorders

A1. Functional HeartburnDiagnostic criteria* Must include all of the following:

. Burning retrosternal discomfort or pain

. Absence of evidence that gastroesophageal acid reflux is the cause of the

symptom

. Absence of histopathology-based esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

A2. Functional Chest Pain of Presumed Esophageal OriginDiagnostic criteria* Must include all of the following:

. Midline chest pain or discomfort that is not of burning quality

. Absence of evidence that gastroesophageal reflux is the cause of the symptom

. Absence of histopathology-based esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

A3. Functional DysphagiaDiagnostic criteria* Must include all of the following:

. Sense of solid and/or liquid foods sticking, lodging, or passing abnormally

through the esophagus

. Absence of evidence that gastroesophageal reflux is the cause of the symptom

. Absence of histopathology-based esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

A4. GlobusDiagnostic criteria* Must include all of the following:

. Persistent or intermittent, nonpainful sensation of a lump or foreign body

in the throat

. Occurrence of the sensation between meals

. Absence of dysphagia or odynophagia

. Absence of evidence that gastroesophageal reflux is the cause of the symptom

. Absence of histopathology-based esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

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Appendix A: Rome III Diagnostic Criteria for FGIDs

B. Functional Gastroduodenal Disorders

B1. FUNCTIONAL DYSPEPSIA Diagnostic criteria* Must include:

. One or more of the following:

a. Bothersome postprandial fullness

b. Early satiation

c. Epigastric pain

d. Epigastric burning

AND

. No evidence of structural disease (including at upper endoscopy) that is likely

to explain the symptoms

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B1a. Postprandial Distress SyndromeDiagnostic criteria* Must include one or both of the following:

. Bothersome postprandial fullness, occurring after ordinary-sized meals,

at least several times per week

. Early satiation that prevents finishing a regular meal, at least several times

per week

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

Supportive criteria . Upper abdominal bloating or postprandial nausea or excessive belching

can be present

. Epigastric pain syndrome may coexist

B1b. Epigastric Pain SyndromeDiagnostic criteria* Must include all of the following:

. Pain or burning localized to the epigastrium of at least moderate severity,

at least once per week

. The pain is intermittent

. Not generalized or localized to other abdominal or chest regions

. Not relieved by defecation or passage of flatus

. Not fulfilling criteria for gallbladder and sphincter of Oddi disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

Supportive criteria . The pain may be of a burning quality, but without a retrosternal component

. The pain is commonly induced or relieved by ingestion of a meal, but may

occur while fasting

. Postprandial distress syndrome may coexist

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Appendix A: Rome III Diagnostic Criteria for FGIDs

B2. BELCHING DISORDERS

B2a. AerophagiaDiagnostic criteria* Must include all of the following:

. Troublesome repetitive belching at least several times a week

. Air swallowing that is objectively observed or measured

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B2b. Unspecified Excessive BelchingDiagnostic criteria* Must include all of the following:

. Troublesome repetitive belching at least several times a week

. No evidence that excessive air swallowing underlies the symptom

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B3. NAUSEA AND VOMITING DISORDERS

B3a. Chronic Idiopathic NauseaDiagnostic criteria* Must include all of the following:

. Bothersome nausea occurring at least several times per week

. Not usually associated with vomiting

. Absence of abnormalities at upper endoscopy or metabolic disease

that explains the nausea

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B3b. Functional VomitingDiagnostic criteria* Must include all of the following:

. On average one or more episodes of vomiting per week

. Absence of criteria for an eating disorder, rumination, or major

psychiatric disease according to DSM-IV

. Absence of self-induced vomiting and chronic cannabinoid use and

absence of abnormalities in the central nervous system or metabolic

diseases to explain the recurrent vomiting

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

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Appendix A: Rome III Diagnostic Criteria for FGIDs

B3c. Cyclic Vomiting SyndromeDiagnostic criteria Must include all of the following:

. Stereotypical episodes of vomiting regarding onset (acute) and duration

(less than one week)

. Three or more discrete episodes in the prior year

. Absence of nausea and vomiting between episodes

Supportive criterion History or family history of migraine headaches

B4. Rumination Syndrome in AdultsDiagnostic criteria Must include both of the following:

. Persistent or recurrent regurgitation of recently ingested food into the mouth

with subsequent spitting or remastication and swallowing

. Regurgitation is not preceded by retching

Supportive criteria . Regurgitation events are usually not preceded by nausea

. Cessation of the process when the regurgitated material becomes acidic

. Regurgitant contains recognizable food with a pleasant taste

C. Functional Bowel Disorders

C1. Irritable Bowel SyndromeDiagnostic criterion*Recurrent abdominal pain or discomfort** at least days/month in the last

months associated with two or more of the following:

. Improvement with defecation

. Onset associated with a change in frequency of stool

. Onset associated with a change in form (appearance) of stool

* Criterion fulfilled for the last months with symptom onset at least months prior to diagnosis

** “Discomfort” means an uncomfortable sensation not described as pain.

In pathophysiology research and clinical trials, a pain/discomfort frequency of at least days a week during screening evaluation is recommended for subject eligibility.

C2. Functional BloatingDiagnostic criteria* Must include both of the following:

. Recurrent feeling of bloating or visible distension at least days/month in

the last months

. Insufficient criteria for a diagnosis of functional dyspepsia, irritable bowel

syndrome, or other functional GI disorder

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

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Appendix A: Rome III Diagnostic Criteria for FGIDs

C3. Functional ConstipationDiagnostic criteria*

. Must include two or more of the following:

a. Straining during at least % of defecations

b. Lumpy or hard stools in at least % of defecations

c. Sensation of incomplete evacuation for at least % of defecations

d. Sensation of anorectal obstruction/blockage for at least % of defecations

e. Manual maneuvers to facilitate at least % of defecations (e.g., digital

evacuation, support of the pelvic floor)

f. Fewer than three defecations per week

. Loose stools are rarely present without the use of laxatives

. Insufficient criteria for irritable bowel syndrome

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

C4. Functional DiarrheaDiagnostic criterion*

Loose (mushy) or watery stools without pain occurring in at least % of stools

* Criterion fulfilled for the last months with symptom onset at least months prior to diagnosis

C5. Unspecified Functional Bowel DisorderDiagnostic criterion*

Bowel symptoms not attributable to an organic etiology that do not meet criteria

for the previously defined categories

* Criterion fulfilled for the last months with symptom onset at least months prior to diagnosis

D. Functional Abdominal Pain Syndrome

D. Functional Abdominal Pain SyndromeDiagnostic criteria* Must include all of the following:

. Continuous or nearly continuous abdominal pain

. No or only occasional relationship of pain with physiological events

(e.g., eating, defecation, or menses)

. Some loss of daily functioning

. The pain is not feigned (e.g., malingering)

. Insufficient symptoms to meet criteria for another functional gastrointestinal

disorder that would explain the pain

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

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Appendix A: Rome III Diagnostic Criteria for FGIDs

E. Functional Gallbladder and Sphincter of Oddi Disorders

E. Functional Gallbladder and Sphincter of Oddi DisordersDiagnostic criteria Must include episodes of pain located in the epigastrium

and/or right upper quadrant and all of the following: . Episodes lasting minutes or longer

. Recurrent symptoms occurring at different intervals (not daily)

. The pain builds up to a steady level

. The pain is moderate to severe enough to interrupt the patient’s daily activities

or lead to an emergency department visit

. The pain is not relieved by bowel movements

. The pain is not relieved by postural change

. The pain is not relieved by antacids

. Exclusion of other structural disease that would explain the symptoms

Supportive criteria The pain may present with one or more of the following:

. Associated with nausea and vomiting

. Radiates to the back and/or right infra subscapular region

. Awakens from sleep in the middle of the night

E1. Functional Gallbladder DisorderDiagnostic criteria Must include all of the following:

. Criteria for functional gallbladder and sphincter of Oddi disorder

. Gallbladder is present

. Normal liver enzymes, conjugated bilirubin, and amylase/lipase

E2. Functional Biliary Sphincter of Oddi DisorderDiagnostic criteria Must include both of the following:

. Criteria for functional gallbladder and sphincter of Oddi disorder

. Normal amylase/lipase

Supportive criterion Elevated serum transaminases, alkaline phosphatase, or conjugated bilirubin

temporarily related to at least two pain episodes

E3. Functional Pancreatic Sphincter of Oddi DisorderDiagnostic criteria Must include both of the following:

. Criteria for functional gallbladder and sphincter of Oddi disorder and

. Elevated amylase/lipase

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Appendix A: Rome III Diagnostic Criteria for FGIDs

F. Functional Anorectal Disorders

F1. Functional Fecal IncontinenceDiagnostic criteria*

. Recurrent uncontrolled passage of fecal material in an individual with a

developmental age of at least years and one or more of the following:

a. Abnormal functioning of normally innervated and structurally

intact muscles

b. Minor abnormalities of sphincter structure and/or innervation

c. Normal or disordered bowel habits, (i.e., fecal retention or diarrhea)

d. Psychological causes

AND

. Exclusion of all the following:

a. Abnormal innervation caused by lesion(s) within the brain (e.g., dementia),

spinal cord, or sacral nerve roots, or mixed lesions (e.g., multiple

sclerosis), or as part of a generalized peripheral or autonomic neuropathy

(e.g., due to diabetes)

b. Anal sphincter abnormalities associated with a multisystem disease

(e.g., scleroderma)

c. Structural or neurogenic abnormalities believed to be the major or primary

cause of fecal incontinence

* Criteria fulfilled for the last months

F2. FUNCTIONAL ANORECTAL PAIN

F2a. Chronic ProctalgiaDiagnostic criteria* Must include all of the following:

. Chronic or recurrent rectal pain or aching

. Episodes last minutes or longer

. Exclusion of other causes of rectal pain such as ischemia, inflammatory

bowel disease, cryptitis, intramuscular abscess, anal fissure, hemorrhoids,

prostatitis, and coccygodynia

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

Chronic proctalgia may be further characterized into levator ani syndrome or unspecif ied anorectal pain based on digital rectal examination.

F2a.1. Levator Ani SyndromeDiagnostic criterion Symptom criteria for chronic proctalgia and tenderness during posterior traction

on the puborectalis

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Appendix A: Rome III Diagnostic Criteria for FGIDs

F2a.2. Unspecified Functional Anorectal PainDiagnostic criterion

Symptom criteria for chronic proctalgia but no tenderness during posterior

traction on the puborectalis

F2b. Proctalgia FugaxDiagnostic criteria Must include all of the following:

. Recurrent episodes of pain localized to the anus or lower rectum

. Episodes last from seconds to minutes

. There is no anorectal pain between episodes

For research purposes criteria must be fulfilled for months; however, clinical diagnosis and evaluation may be made prior to months.

F3. Functional Defecation DisordersDiagnostic criteria*

. The patient must satisfy diagnostic criteria for functional constipation**

. During repeated attempts to defecate must have at least two of the following:

a. Evidence of impaired evacuation, based on balloon expulsion test

or imaging

b. Inappropriate contraction of the pelvic floor muscles (i.e., anal sphincter or

puborectalis) or less than % relaxation of basal resting sphincter pressure

by manometry, imaging, or EMG

c. Inadequate propulsive forces assessed by manometry or imaging

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

** Diagnostic criteria for functional constipation: () Must include two or more of the following: (a) Straining during at least % of defeca-tions, (b) Lumpy or hard stools in at least % of defecations, (c) Sensation of incomplete evacuation for at least % of defecations, (d) Sensation of anorectal obstruction/blockage for at least % of defecations, (e) Manual maneuvers to facilitate at least % of defeca-tions (e.g., digital evacuation, support of the pelvic floor), (f ) Fewer than three defecations per week. () Loose stools are rarely present without the use of laxatives. () Insufficient criteria for irritable bowel syndrome.

F3a. Dyssynergic DefecationDiagnostic criterion

Inappropriate contraction of the pelvic floor or less than % relaxation of basal

resting sphincter pressure with adequate propulsive forces during attempted

defecation

F3b. Inadequate Defecatory PropulsionDiagnostic criterion

Inadequate propulsive forces with or without inappropriate contraction or less

than % relaxation of the anal sphincter during attempted defecation

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Appendix A: Rome III Diagnostic Criteria for FGIDs

G. Childhood Functional GI Disorders: Infant/Toddler

G1. Infant RegurgitationDiagnostic criteria Must include both of the following in otherwise healthy infants

3 weeks to 12 months of age: . Regurgitation two or more times per day for or more weeks

. No retching, hematemesis, aspiration, apnea, failure to thrive, feeding or

swallowing difficulties, or abnormal posturing

G2. Infant Rumination SyndromeDiagnostic criteria Must include all of the following for at least 3 months:

. Repetitive contractions of the abdominal muscles, diaphragm, and tongue

. Regurgitation of gastric content into the mouth, which is either expectorated

or rechewed and reswallowed

. Three or more of the following:

a. Onset between and months

b. Does not respond to management for gastroesophageal reflux disease,

or to anticholinergic drugs, hand restraints, formula changes, and

gavage or gastrostomy feedings

c. Unaccompanied by signs of nausea or distress

d. Does not occur during sleep and when the infant is interacting with

individuals in the environment

G3. Cyclic Vomiting SyndromeDiagnostic criteria Must include both of the following:

. Two or more periods of intense nausea and unremitting vomiting or retching

lasting hours to days

. Return to usual state of health lasting weeks to months

G4. Infant ColicDiagnostic criteria Must include all of the following in infants from birth to

4 months of age: . Paroxysms of irritability, fussing or crying that starts and stops without

obvious cause

. Episodes lasting or more hours/day and occurring at least days/wk for

at least week

. No failure to thrive

G5. Functional DiarrheaDiagnostic criteria Must include all of the following:

. Daily painless, recurrent passage of three or more large, unformed stools

. Symptoms that last more than weeks

. Onset of symptoms that begins between and months of age

. Passage of stools that occurs during waking hours

. There is no failure-to-thrive if caloric intake is adequate

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Appendix A: Rome III Diagnostic Criteria for FGIDs

G6. Infant DyscheziaDiagnostic criteria Must include both of the following in an infant less than 6 months of age

. At least minutes of straining and crying before successful passage of soft stools

. No other health problems

G7. Functional ConstipationDiagnostic criteria Must include one month of at least two of the following

in infants up to 4 years of age: . Two or fewer defecations per week

. At least one episode/week of incontinence after the acquisition of toileting skills

. History of excessive stool retention

. History of painful or hard bowel movements

. Presence of a large fecal mass in the rectum

. History of large diameter stools which may obstruct the toilet

Accompanying symptoms may include irritability, decreased appetite, and/or early

satiety. The accompanying symptoms disappear immediately following passage of a

large stool.

H. Childhood Functional GI Disorders: Child/Adolescent

H1. VOMITING AND AEROPHAGIA

H1a. Adolescent Rumination Syndrome Diagnostic criteria* Must include all of the following:

. Repeated painless regurgitation and rechewing or expulsion of food that

a. begin soon after ingestion of a meal

b. do not occur during sleep

c. do not respond to standard treatment for gastroesophageal reflux

. No retching

. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process

that explains the subject’s symptoms

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

H1b. Cyclic Vomiting Syndrome Diagnostic criteria Must include both of the following:

. Two or more periods of intense nausea and unremitting vomiting or retching lasting

hours to days

. Return to usual state of health lasting weeks to months

H1c. AerophagiaDiagnostic criteria* Must include at least two of the following:

. Air swallowing

. Abdominal distention due to intraluminal air

. Repetitive belching and/or increased flatus

* Criteria fulfilled at least once per week for at least months prior to diagnosis

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Appendix A: Rome III Diagnostic Criteria for FGIDs

H2. ABDOMINAL PAIN-RELATED FUNCTIONAL GI DISORDERS

H2a. Functional DyspepsiaDiagnostic criteria* Must include all of the following:

. Persistent or recurrent pain or discomfort centered in the upper abdomen

(above the umbilicus)

. Not relieved by defecation or associated with the onset of a change in stool

frequency or stool form (i.e., not irritable bowel syndrome)

. No evidence of an inflammatory, anatomic, metabolic or neoplastic process

that explains the subject’s symptoms

* Criteria fulfilled at least once per week for at least months prior to diagnosis

H2b. Irritable Bowel SyndromeDiagnostic criteria* Must include both of the following:

. Abdominal discomfort** or pain associated with two or more of the following

at least % of the time:

a. Improvement with defecation

b. Onset associated with a change in frequency of stool

c. Onset associated with a change in form (appearance) of stool

. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process

that explains the subject’s symptoms

* Criteria fulfilled at least once per week for at least months prior to diagnosis

** “Discomfort” means an uncomfortable sensation not described as pain.

H2c. Abdominal MigraineDiagnostic criteria* Must include all of the following:

. Paroxysmal episodes of intense, acute periumbilical pain that lasts for

hour or more

. Intervening periods of usual health lasting weeks to months

. The pain interferes with normal activities

. The pain is associated with of the following:

a. Anorexia

b. Nausea

c. Vomiting

d. Headache

e. Photophobia

f. Pallor

. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process

considered that explains the subject’s symptoms

* Criteria fulfilled two or more times in the preceding months

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Appendix A: Rome III Diagnostic Criteria for FGIDs

H2d. Childhood Functional Abdominal PainDiagnostic criteria* Must include all of the following:

. Episodic or continuous abdominal pain

. Insufficient criteria for other FGIDs

. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process

that explains the subject’s symptoms

* Criteria fulfilled at least once per week for at least months prior to diagnosis

H2d1. Childhood Functional Abdominal Pain SyndromeDiagnostic criteria* Must satisfy criteria for childhood functional abdominal pain and

have at least 25% of the time one or more of the following: . Some loss of daily functioning

. Additional somatic symptoms such as headache, limb pain, or difficulty

sleeping

* Criteria fulfilled at least once per week for at least months prior to diagnosis

H3. CONSTIPATION AND INCONTINENCE

H3a. Functional Constipation Diagnostic criteria* Must include two or more of the following in a child with a

developmental age of at least 4 years with insufficient criteria for diagnosis of IBS:

. Two or fewer defecations in the toilet per week

. At least one episode of fecal incontinence per week

. History of retentive posturing or excessive volitional stool retention

. History of painful or hard bowel movements

. Presence of a large fecal mass in the rectum

. History of large diameter stools which may obstruct the toilet

* Criteria fulfilled at least once per week for at least months prior to diagnosis

H3b. Nonretentive Fecal IncontinenceDiagnostic criteria* Must include all of the following in a child with a developmental

age at least 4 years: . Defecation into places inappropriate to the social context at least once per

month

. No evidence of an inflammatory, anatomic, metabolic, or neoplastic process

that explains the subject’s symptoms

. No evidence of fecal retention

* Criteria fulfilled for at least months prior to diagnosis

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Appendix B

Comparison Table of

Rome II & Rome III

Adult Diagnostic

Criteria

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ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA

A. Functional Esophageal Disorders A. Functional Esophageal Disorders

A1. Functional Heartburn

Diagnostic criteria* Must include all of the following:

. Burning retrosternal discomfort or pain

. Absence of evidence that gastroesophageal

acid reflux is the cause of the symptom

. Absence of histopathology-based

esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

A4. Functional Heartburn

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Burning retrosternal discomfort or pain;

and

. Absence of pathologic gastroesophageal

reflux, achalasia, or other motility disorder

with a recognized pathologic basis.

A2. Functional Chest Pain of Presumed Esophageal Origin

Diagnostic criteria* Must include all of the following:

. Midline chest pain or discomfort that is not

of burning quality

. Absence of evidence that gastroesophageal

reflux is the cause of the symptom

. Absence of histopathology-based

esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

A3. Functional Chest Pain of Presumed Esophageal Origin

At least 12 weeks, which need not be consecutive, within the preceding 12 months of:

. Midline chest pain or discomfort that is not

of burning quality; and

. Absence of pathologic gastroesophageal

reflux, achalasia, or other motility disorder

with a recognized pathologic basis.

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A3. Functional Dysphagia

Diagnostic criteria* Must include all of the following:

. Sense of solid and/or liquid foods sticking,

lodging, or passing abnormally through the

esophagus

. Absence of evidence that gastroesophageal

reflux is the cause of the symptom

. Absence of histopathology-based

esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

A5. Functional Dysphagia

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Sense of solid and/or liquid foods sticking,

lodging, or passing abnormally through the

esophagus; and

. Absence of pathologic gastroesophageal

reflux, achalasia, or other motility disorder

with a recognized pathologic basis.

A4. Globus

Diagnostic criteria* Must include all of the following:

. Persistent or intermittent, nonpainful

sensation of a lump or foreign body in

the throat

. Occurrence of the sensation between meals

. Absence of dysphagia or odynophagia

. Absence of evidence that gastroesophageal

reflux is the cause of the symptom

. Absence of histopathology-based

esophageal motility disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

A1. Globus

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. The persistent or intermittent sensation of a

lump or foreign body in the throat;

. Occurrence of the sensation between meals;

. Absence of dysphagia and odynophagia; and

. Absence of pathologic gastroesophageal

reflux, achalasia, or other motility disorder

with a recognized pathologic basis (e.g.,

scleroderma of the esophagus).

Rome III criteria do not include unspecif ied functional esophageal disorder as in Rome II.

A6. Unspecified Functional Esophageal Disorder

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Unexplained symptoms attributed to the

esophagus that do not fit into the previously

described categories; and

. Absence of pathologic gastroesophageal

reflux, achalasia, or other motility disorder

with a recognized pathologic basis.

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ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA

B. Functional Gastroduodenal Disorders

B. Functional Gastroduodenal Disorders

Note major changes in classification for dyspepsia and nausea and vomiting disorders

B1. Functional Dyspepsia

Diagnostic criteria* Must include:

. One or more of the following:

a. Bothersome postprandial fullness

b. Early satiation

c. Epigastric pain

d. Epigastric burning

AND

. No evidence of structural disease (including

at upper endoscopy) that is likely to explain

the symptoms

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B1a. Postprandial Distress Syndrome

Diagnostic criteria* Must include one or both of the following:

. Bothersome postprandial fullness,

occurring after ordinary-sized meals, at

least several times per week

. Early satiation that prevents finishing a

regular meal, at least several times per

week

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

Supportive criteria

. Upper abdominal bloating or

postprandial nausea or excessive belching

can be present

. Epigastric pain syndrome may coexist

B1. Functional Dyspepsia

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Persistent or recurrent symptoms (pain

or discomfort centered in the upper

abdomen);

. No evidence of organic disease (including

at upper endoscopy) that is likely to explain

the symptoms; and

. No evidence that dyspepsia is exclusively

relieved by defecation or associated with the

onset of a change in stool frequency or stool

form.

B1a. Ulcer-like dyspepsia Pain centered in the upper abdomen is the

predominant (most bothersome) symptom.

B1b. Dysmotility-like dyspepsia An unpleasant or troublesome nonpainful

sensation (discomfort) centered in the

upper abdomen is the predominant

symptom; this sensation may be

characterized by or associated with upper

abdominal fullness, early satiety, bloating,

or nausea.

B1c. Unspecified (nonspecific) dyspepsia Symptomatic patients whose symptoms

do not fulfill the criteria for ulcer-like or

dysmotility-like dyspepsia.

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B1b. Epigastric Pain Syndrome

Diagnostic criteria* Must include all of the following:

. Pain or burning localized to the

epigastrium of at least moderate severity,

at least once per week

. The pain is intermittent

. Not generalized or localized to other

abdominal or chest regions

. Not relieved by defecation or passage of

flatus

. Not fulfilling criteria for gallbladder and

sphincter of Oddi disorders

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

Supportive criteria

. The pain may be of a burning quality, but

without a retrosternal component

. The pain is commonly induced or

relieved by ingestion of a meal, but may

occur while fasting

. Postprandial distress syndrome may

coexist

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B2. Belching Disorders

B2a. Aerophagia

Diagnostic criteria* Must include all of the following:

. Troublesome repetitive belching at least

several times a week

. Air swallowing that is objectively

observed or measured

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B2b. Unspecified Excessive Belching

Diagnostic criteria* Must include all of the following:

. Troublesome repetitive belching at least

several times a week

. No evidence that excessive air swallowing

underlies the symptom

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B2. Aerophagia

At least 12 weeks, which need not be consecutive, or more in the preceding 12 months of:

. Air swallowing that is objectively observed;

and

. Troublesome repetitive belching.

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B3. Nausea and Vomiting Disorders

B3a. Chronic Idiopathic Nausea

Diagnostic criteria* Must include all of the following:

. Bothersome nausea occurring at least

several times per week

. Not usually associated with vomiting

. Absence of abnormalities at upper

endoscopy or metabolic disease that

explains the nausea

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B3b. Functional Vomiting

Diagnostic criteria* Must include all of the following:

. On average one or more episodes of

vomiting per week

. Absence of criteria for an eating disorder,

rumination, or major psychiatric disease

according to DSM-IV

. Absence of self-induced vomiting and

chronic cannabinoid use and absence

of abnormalities in the central nervous

system or metabolic diseases to explain

the recurrent vomiting

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

B3. Functional Vomiting

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Frequent episodes of vomiting, occurring

on at least three separate days in a week over

three months;

. Absence of criteria for an eating disorder,

rumination, or major psychiatric disease

according to DSM-IV;

. Absence of self-induced and medication-

induced vomiting; and

. Absence of abnormalities in the gut or

central nervous system, and metabolic

diseases to explain the recurrent vomiting.

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B3c. Cyclic Vomiting Syndrome

Diagnostic criteria Must include all of the following:

. Stereotypical episodes of vomiting

regarding onset (acute) and duration

(less than one week)

. Three or more discrete episodes in the

prior year

. Absence of nausea and vomiting between

episodes

Supportive criteria

History or family history of migraine

headaches

B4. Rumination Syndrome in Adults

Diagnostic criteria* Must include both of the following:

. Persistent or recurrent regurgitation of

recently ingested food into the mouth with

subsequent spitting or remastication and

swallowing

. Regurgitation is not preceded by retching

Supportive criteria

. Regurgitation events are usually not

preceded by nausea

. Cessation of the process when the

regurgitated material becomes acidic

. Regurgitant contains recognizable food

with a pleasant taste

The Rome III criteria classify rumination as a functional gastroduodenal disorder. In the Rome II classification, rumination was considered a func-tional esophageal disorder.

A2. Rumination Syndrome

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Persistent or recurrent regurgitation of

recently ingested food into the mouth with

subsequent remastication and swallowing;

. Absence of nausea and vomiting;

. Cessation of the process when the

regurgitated material becomes acidic; and

. Absence of pathologic gastroesophageal

reflux, achalasia, or other motility disorder

with a recognized pathologic basis as the

primary disorder.

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ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA

C. Functional Bowel Disorders C. Functional Bowel Disorders

C1. Irritable Bowel Syndrome

Diagnostic criterion*

Recurrent abdominal pain or discomfort** at

least 3 days/month in last 3 months associated

with two or more of the following:

. Improvement with defecation

. Onset associated with a change in frequency

of stool

. Onset associated with a change in form

(appearance) of stool

* Criterion fulfilled for the last months with symptom onset at least months prior to diagnosis

**“Discomfort” means an uncomfortable sensation not described as pain.

In pathophysiology research and clinical trials, a pain/discomfort frequency of at least days a week during the screening evaluation is recommended for subject eligibility.

C1. Irritable Bowel Syndrome

At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discom-fort or pain that has two out of three features:

. Relieved with defecation; and/or

. Onset associated with a change in frequency

of stool; and/or

. Onset associated with a change in form

(appearance) of stool.

Symptoms that Cumulatively Support the Diagnosis of Irritable Bowel Syndrome

– Abnormal stool frequency (for research

purposes “abnormal” may be defined as

greater than bowel movements per day

and less than bowel movements per week);

– Abnormal stool form (lumpy/hard or loose/

watery stool);

– Abnormal stool passage (straining, urgency,

or feeling of incomplete evacuation);

– Passage of mucus;

– Bloating or feeling of abdominal distension.

C2. Functional Bloating

Diagnostic criteria* Must include both of the following:

. Recurrent feeling of bloating or visible

distension at least days/month in the last

months

. Insufficient criteria for a diagnosis of

functional dyspepsia, irritable bowel

syndrome, or other functional GI disorder

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

C2. Functional Abdominal Bloating

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Feeling of abdominal fullness, bloating, or

visible distension; and

. Insufficient criteria for a diagnosis of

functional dyspepsia, irritable bowel

syndrome, or other functional disorder.

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C3. Functional Constipation

Diagnostic criteria*

. Must include two or more of the following:

a. Straining during at least % of

defecations

b. Lumpy or hard stools in at least % of

defecations

c. Sensation of incomplete evacuation for

at least % of defecations

d. Sensation of anorectal obstruction/

blockage for at least % of defecations

e. Manual maneuvers to facilitate at

least % of defecations (e.g., digital

evacuation, support of the pelvic floor)

f. Fewer than three defecations per week

. Loose stools are rarely present without the

use of laxatives

. Insufficient criteria for irritable bowel

syndrome

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

C3. Functional Constipation

At least 12 weeks, which need not be consecutive, in the preceding 12 months of two or more of:

. Straining > / of defecations;

. Lumpy or hard stools > / of defecations;

. Sensation of incomplete evacuation > / of

defecations;

. Sensation of anorectal obstruction/blockage

> / of defecations;

. Manual maneuvers to facilitate > / of

defecations (e.g., digital evacuation, support

of the pelvic floor); and/or

. < defecations per week.

Loose stools are not present, and there are insufficient criteria for IBS.

C4. Functional Diarrhea

Diagnostic criterion*

Loose (mushy) or watery stools without pain

occurring in at least % of stools

* Criterion fulfilled for the last months with symptom onset at least months prior to diagnosis

C4. Functional Diarrhea

At least 12 weeks, which need not be consecutive, in the preceding 12 months of:

. Loose (mushy) or watery stools

. Present > / of the time; and

. No abdominal pain.

C.5. Unspecified Functional Bowel Disorder

Diagnostic criterion*

Bowel symptoms not attributable to an

organic etiology that do not meet criteria for

the previously defined categories

* Criterion fulfilled for the last months with symptom onset at least months prior to diagnosis

C5. Unspecified Functional Bowel Disorder

Bowel symptoms in the absence of organic

disease that do not fit into the previously

defined categories of functional bowel

disorders.

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D. Functional Abdominal Pain Syndrome

D. Functional Abdominal Pain

D. Functional Abdominal Pain Syndrome

Diagnostic criteria* Must include all of the following:

. Continuous or nearly continuous

abdominal pain

. No or only occasional relationship of pain

with physiological events (e.g., eating,

defecation, or menses)

. Some loss of daily functioning

. The pain is not feigned (e.g., malingering)

. Insufficient symptoms to meet criteria for

another functional gastrointestinal disorder

that would explain the pain

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

D1. Functional Abdominal Pain Syndrome

At least 6 months of:

. Continuous or nearly continuous

abdominal pain; and

. No or only occasional relationship of pain

with physiological events (e.g., eating,

defecation, or menses); and

. Some loss of daily functioning; and

. The pain is not feigned (e.g., malingering),

and

. Insufficient criteria for other functional

gastrointestinal disorders that would

explain the abdominal pain.

The Rome III Criteria do not include Unspecified Functional Abdominal Pain

D2. Unspecified Functional Abdominal Pain

This is functional abdominal pain that fails to

reach criteria for functional abdominal pain

syndrome.

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E. Functional Gallbladder and Sphincter of Oddi Disorders

E. Functional Disorders of the Biliary Tract and the Pancreas

E. Functional Gallbladder and Sphincter of Oddi Disorders

Diagnostic criteria Must include episodes of pain located in the epigastrium and/or right upper quadrant and all of the following:

. Episodes lasting minutes or longer

. Recurrent symptoms occurring at different

intervals (not daily)

. The pain builds up to a steady level

. The pain is moderate to severe enough to

interrupt the patient’s daily activities or lead

to an emergency department visit

. The pain is not relieved by bowel

movements

. The pain is not relieved by postural change

. The pain is not relieved by antacids

. Exclusion of other structural disease that

would explain the symptoms

Supportive criteria

The pain may present with one or more of the

following:

. Associated with nausea and vomiting

. Radiates to the back and/or right infra

subscapular region

. Awakens from sleep in the middle of the

night

E1. Functional Gallbladder Disorder

Diagnostic criteria Must include all of the following:

. Criteria for functional gallbladder and

sphincter of Oddi disorder and

. Gallbladder is present

. Normal liver enzymes, conjugated

bilirubin, and amylase/lipase

E1. Gallbladder Dysfunction

Episodes of severe steady pain located in the epi-gastrium and right upper quadrant, and all of the following:

. Symptom episodes last minutes or more,

with pain-free intervals;

. Symptoms have occurred on one or more

occasions in the previous months;

. The pain is steady and interrupts daily

activities or requires consultation with a

physician;

. There is no evidence of structural

abnormalities to explain the symptoms;

. There is abnormal gallbladder functioning

with regard to emptying.

E2. Sphincter of Oddi Dysfunction

Episodes of severe steady pain located in the epi-gastrium and right upper quadrant, and all of the following:

. Symptom episodes last minutes or more,

with pain-free intervals; and

. Symptoms have occurred on one or more

occasions in the previous months; and

. The pain is steady and interrupts daily

activities or requires consultation with a

physician; and

. There is no evidence of structural

abnormalities to explain the symptoms.

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E2. Functional Biliary Sphincter of Oddi Disorder

Diagnostic criteria Must include both of the following:

. Criteria for functional sphincter of Oddi

disorder

. Normal amylase/lipase

Supportive criterion

Elevated serum transaminases, alkaline

phosphatase, or conjugated bilirubin

temporarily related to at least two pain

episodes

E3. Functional Pancreatic Sphincter of Oddi Disorder

Diagnostic criteria Must include both of the following:

. Criteria for functional gallbladder and

sphincter of Oddi Disorder and

. Elevated amylase/lipase

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ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA

F. Functional Anorectal Disorders F. Functional Disorders of the Anus and Rectum

F1. Functional Fecal Incontinence

Diagnostic criteria*

. Recurrent uncontrolled passage of

fecal material in an individual with a

developmental age of at least years and one

or more of the following:

a. Abnormal functioning of normally

innervated and structurally intact

muscles

b. Minor abnormalities of sphincter

structure and/or innervation

c. Normal or disordered bowel habits, (i.e.,

fecal retention or diarrhea)

d. Psychological causes

AND

. Exclusion of all of the following:

a. Abnormal innervation caused by

lesion(s) within the brain (e.g.,

dementia), spinal cord, or sacral nerve

roots, or mixed lesions (e.g., multiple

sclerosis), or as part of a generalized

peripheral or autonomic neuropathy

(e.g., due to diabetes)

b. Anal sphincter abnormalities associated

with a multisystem disease (e.g.

scleroderma)

c. Structural or neurogenic abnormalities

believed to be the major or primary cause

of fecal incontinence.

* Criteria fulfilled for the last months

F1. Functional Fecal Incontinence

Recurrent uncontrolled passage of fecal material for at least one month, in an individual with a developmental age of at least 4 years, associated with:

. Fecal impaction; or

. Diarrhea; or

. Nonstructural anal sphincter dysfunction.

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ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA

F2. Functional Anorectal Pain

F2a. Chronic Proctalgia

Diagnostic criteria* Must include all of the following:

. Chronic or recurrent rectal pain or

aching

. Episodes last minutes or longer

. Exclusion of other causes of rectal pain

such as ischemia, inflammatory bowel

disease, cryptitis, intramuscular abscess,

anal fissure, hemorrhoids, prostatitis, and

coccygodynia

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

Chronic proctalgia may be further characterized into levator ani syndrome or unspecified anorectal pain based on digital rectal examination.

F2a.1. Levator Ani Syndrome

Diagnostic criterionSymptom criteria for chronic proctalgia

and tenderness during posterior traction

on the puborectalis

F2a.2. Unspecified Functional Anorectal Pain

Diagnostic criterionSymptom criteria for chronic proctalgia

but no tenderness during posterior

traction on the puborectalis

F2. Functional Anorectal Pain

F2a. Levator Ani Syndrome

At least 12 weeks, which need not be consecu-tive, in the preceding 12 months of:

. Chronic or recurrent rectal pain or

aching;

. Episodes last minutes or longer; and

. Other causes of rectal pain such as

ischemia, inflammatory bowel disease,

cryptitis, intramuscular abscess, fissure,

hemorrhoids, prostatitis, and solitary

rectal ulcer have been excluded.

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F2b. Proctalgia Fugax

Diagnostic criteria Must include all of the following:

. Recurrent episodes of pain localized to

the anus or lower rectum

. Episodes last from seconds to minutes

. There is no anorectal pain between

episodes

For research purposes criteria must be fulfilled for months; however, clinical diagnosis and evaluation may be made prior to months.

F2b. Proctalgia Fugax . Recurrent episodes of pain localized to

the anus or lower rectum;

. Episodes last from seconds to minutes;

and

. There is no anorectal pain between

episode

F3. Functional Defecation Disorders

Diagnostic criteria*

. The patient must satisfy diagnostic criteria

for functional constipation**

. During repeated attempts to defecate must

have at least two of the following:

a. Evidence of impaired evacuation, based

on balloon expulsion test or imaging

b. Inappropriate contraction of the pelvic

floor muscles (i.e., anal sphincter or

puborectalis) or less than % relaxation

of basal resting sphincter pressure by

manometry, imaging, or EMG

c. Inadequate propulsive forces assessed by

manometry or imaging

* Criteria fulfilled for the last months with symptom onset at least months prior to diagnosis

** Diagnostic criteria for functional constipation: () Must include two or more of the following: (a) Straining during at least % of defecations, (b) Lumpy or hard stools in at least % of defecations, (c) Sensation of incomplete evacuation for at least % of defecations, (d) Sensation of anorectal obstruction/blockage for at least % of defecations, (e) Manual maneuvers to facilitate at least % of defecations (e.g., digital evacuation, support of the pelvic floor), (f ) Fewer than three defecations per week. () Loose stools are rarely present without the use of laxatives. () There are insufficient criteria for irritable bowel syndrome.

F3. Pelvic Floor Dyssynergia

. The patient must satisfy diagnostic criteria

for functional constipation in Diagnostic

criteria C3;

. There must be manometric, EMG, or

radiologic evidence for inappropriate

contraction or failure to relax the pelvic

floor muscles during repeated attempts to

defecate;

. There must be evidence of adequate

propulsive forces during attempts to

defecate, and

. There must be evidence of incomplete

evacuation.

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F3a. Dyssynergic Defecation

Diagnostic criterionInappropriate contraction of the pelvic floor

or less than % relaxation of basal resting

sphincter pressure with adequate propulsive

forces during attempted defecation

F3b. Inadequate Defecatory Propulsion

Diagnostic criterionInadequate propulsive forces with or

without inappropriate contraction or less

than % relaxation of the anal sphincter

during attempted defecation

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