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Completed
NCT07842354
Antireflux Mucosal Ablation vs Fundoplication for Refractory GERD
Conditions: Antireflux Mucosal Ablation, Laparoscopic Fundoplication Procedure, Refractory GERD, Endoscopic Therapy
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 200
Sponsor: Minia University
Location: Faculty of medicine Minya Minya Governorate
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.
Eligibility Criteria
Inclusion Criteria:
* Adult patients aged 18 years or older
* Diagnosis of refractory gastroesophageal reflux disease (GERD) confirmed by 24-hour pH monitoring and/or endoscopy
* Persistent GERD symptoms despite at least 8 weeks of optimized proton pump inhibitor (PPI) therapy
* Incomplete symptom control or patient intolerance to PPI therapy
* Eligible for either endoscopic or surgical antireflux intervention based on multidisciplinary team assessment
* Ability to provide informed consent for retrospective review of medical records
* Complete medical records available for the study period (January 2023 to December 2024)
Exclusion Criteria:
* Age less than 18 years
* Prior antireflux surgery or endoscopic antireflux procedure
* Severe esophageal motility disorders (e.g., achalasia, diffuse esophageal spasm)
* Esophageal stricture or stenosis
* Hiatal hernia greater than 5 cm
* Barrett's esophagus with high-grade dysplasia or carcinoma
* Active malignancy or life expectancy less than 12 months
* Contraindication to general anesthesia or laparoscopic surgery
* Pregnancy or breastfeeding
* Incomplete follow-up data at 12 months
* Patients who declined participation in the retrospective record review
Source: ClinicalTrials.gov (NCT07842354). StuddyBuddy aggregates publicly available trial information.