CompletedNot Applicable

Comparative Analysis of Postoperative Manometry Outcomes in Nissen vs Toupet Fundoplication

Egypt20 participantsStarted 2024-03-10

Plain-language summary

This randomized controlled trial investigates the effects of laparoscopic Nissen and Toupet fundoplication on postoperative esophageal manometry findings in patients with gastroesophageal reflux disease (GERD). The study, conducted at Ain Shams University Hospitals, involved 20 adult patients randomly assigned to undergo either procedure. Preoperative and postoperative high-resolution manometry (HRM) was used to assess lower esophageal sphincter (LES) pressure and esophageal motility.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients between 18 and 65 years of age * Patients with pre-operable low LES pressure proven by High resolution manometry. * Patients refractory to medical therapy: Persistent symptoms after 12 weeks of maximal medical therapies, recurrence upon cessation of medications. * Patients who are non-compliance with medical therapies or inability to tolerate medical therapies . * Patients with esophageal motility more than 30% Exclusion Criteria: * Patients with esophageal motility less than 30%. * Patent with morbidly obese (BMI more than 35 kg/m2), * Patients with recent upper abdominal surgery or severely shortened esophagus * Extremes of age less than 18 and more than 65. * Patients who are unfit for general anesthesia (ASAIII,IV or V)..

What they're measuring

Lower Esophageal Sphincter (LES) Resting Pressure

Timeframe: 6 Weeks Postoperative

Trial details

NCT IDNCT06986902

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-03-15

View on ClinicalTrials.gov More GERD - Gastro-Esophageal Reflux Disease trials