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Antireflux Mucosal Ablation vs Fundoplication for Refractory GERD

StatusCompleted
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
133 trials monitored
See 3 trials at risk
This study compared two treatments for patients with gastroesophageal reflux disease (GERD) that did not improve with standard acid-reducing medications. The two treatments were Antireflux Mucosal Ablation (ARMA), a newer endoscopic procedure, and laparoscopic Nissen fundoplication, a well-established surgical procedure. Two hundred patients with refractory GERD were enrolled between January 2023 and December 2024 at two tertiary referral centers in Egypt. One hundred patients underwent modified ARMA, and 100 patients underwent laparoscopic Nissen fundoplication. Treatment was determined by a multidisciplinary team according to a standardized protocol. The study looked at quality of life scores related to GERD, whether patients were able to stop taking proton pump inhibitors (PPIs), and whether their DeMeester scores returned to normal at 12 months. It also examined surgical details, complications, recurrence rates, findings from routine endoscopy at 6 months, and overall treatment success. This was a retrospective study, meaning the researchers reviewed existing medical records rather than assigning patients to treatments. The results may help doctors and patients choose the most appropriate treatment for refractory GERD.
Trial Details
NCT Number NCT07842354
Lead Sponsor Minia University
Conditions
(from sponsor)
Antireflux Mucosal Ablation, Laparoscopic Fundoplication Procedure, Refractory GERD, Endoscopic Therapy
Related terms Gastroesophageal Reflux
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov