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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
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
endo_no12 c.indd 9 13/5/2009 3:30:08 µµ
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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
25
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
Appendix A
Rome III
Diagnostic
Criteria for
Functional
Gastrointestinal
Disorders
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
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
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
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
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
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
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
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
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
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
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
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
Appendix B
Comparison Table of
Rome II & Rome III
Adult Diagnostic
Criteria
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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
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.
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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.
ROME III DIAGNOSTIC CRITERIA ROME II DIAGNOSTIC CRITERIA
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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