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Study identifier: NCT07722663 Synced from ClinicalTrials.gov · August 02, 2026
● Completed

Endoscopic Classification of Fundoplication Integrity Predicts Pathologic Reflux

Condition: Gastro Esophageal Reflux  ·  Sponsor: IRCCS Policlinico S. Donato

PhaseN/A
Planned participants153
Who can joinAll sexes, 18 Years to 90 Years
Healthy volunteersNo

About this study

This single-center, two-phase cohort study aimed to develop and validate a simple endoscopic classification of fundoplication integrity after anti-reflux surgery (ARS - Nissen or Toupet fundoplication). Consecutive adult patients undergoing endoscopy, high-resolution manometry (HRM), and reflux monitoring after ARS were included. Retroflexed endoscopic videoclips were reviewed blinded to clinical and functional results. In the development cohort (2018-2024, n=73), individual endoscopic parameters were tested against pathologic GERD (Lyon 2.0 criteria). Three parameters significantly correlated with pathologic reflux: (1) intrathoracic valve location, (2) disrupted valve (deep anterior and/or posterior grooves), and (3) visible hiatal opening. Patients were stratified according to the number of impaired mechanisms (0-3). Symptom burden, manometric abnormalities, and reflux metrics worsened progressively with increasing impairment. The rate of pathologic GERD rose from 11.8% (0 mechanisms) to 37.5% (1-2 mechanisms) to 85.7% (3 mechanisms). The classification was then prospectively validated in an independent cohort (2024-2026, n=49), reproducing the same stepwise correlation. The number of impaired mechanisms showed excellent discriminatory capacity for pathologic GERD (AUC 0.860 in development, 0.870 in validation; overall AUC 0.869). This simple endoscopic classification, based on only three objective parameters, reliably identifies fundoplication failure and correlates with …

This description comes directly from the study's public registry record.

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Locations (1)

IRCCS Policlinico San DonatoSan Donato Milanese, Milan, Italy

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