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COMPLETED
NCT07842354

Antireflux Mucosal Ablation vs Fundoplication for Refractory GERD

Sponsor: Minia University

View on ClinicalTrials.gov

Summary

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.

Official title: Antireflux Mucosal Ablation Versus Laparoscopic Nissen Fundoplication for Refractory Gastroesophageal Reflux Disease: A Comparative Cohort Study of 200 Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2023-01-01

Completion Date

2024-12-31

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

PROCEDURE

Modified Antireflux Mucosal Ablation (ARMA)

Endoscopic antireflux mucosal ablation performed as a less invasive treatment for refractory gastroesophageal reflux disease. This procedure involves endoscopic ablation of the mucosa at the gastroesophageal junction to promote scarring and tightening, thereby reducing reflux.

PROCEDURE

Laparoscopic Nissen Fundoplication

Laparoscopic surgical fundoplication performed as the established surgical treatment for refractory gastroesophageal reflux disease. This procedure involves wrapping the gastric fundus around the lower esophagus to reinforce the antireflux barrier.

Locations (1)

Faculty of medicine

Minya, Minya Governorate, Egypt