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.
Gastroesophageal reflux disease (GERD) that does not respond to proton pump inhibitor (PPI) therapy remains a significant clinical challenge. Laparoscopic Nissen fundoplication is the established surgical option for refractory GERD, but it carries risks of gas-bloat syndrome, dysphagia, and other complications. Antireflux mucosal ablation (ARMA) has emerged as a less invasive endoscopic alternative, but comparative data with fundoplication are limited. This retrospective comparative cohort study enrolled 200 patients with refractory GERD 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 allocation was protocol-driven and determined by a multidisciplinary team. Primary outcomes included GERD-Health Related Quality of Life (GERD-HRQL) scores, PPI cessation rates, and DeMeester score normalization at 12 months. Secondary outcomes included operative parameters, complications, recurrence rates, routine re-endoscopy findings at 6 months, and treatment success rates. Between-group differences were assessed using the chi-square test for proportions and the independent samples t-test or Mann-Whitney U test for continuous variables. This study aims to provide comparative evidence on the safety and effectiveness of ARMA versus laparoscopic Nissen fundoplication in patients with refractory GERD, potentially informing clinical decision-making and treatment selection.
Study Type
OBSERVATIONAL
Enrollment
200
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.
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.
Faculty of medicine
Minya, Minya Governorate, Egypt
GERD-Health Related Quality of Life (GERD-HRQL) Score at 12 Months
Change in GERD-Health Related Quality of Life (GERD-HRQL) scores from baseline to 12 months after treatment. The GERD-HRQL is a validated questionnaire that assesses heartburn, regurgitation, and dysphagia symptoms and their impact on quality of life. Lower scores indicate better symptom control and improved quality of life.
Time frame: Baseline and 12 months after treatment
Proton Pump Inhibitor (PPI) Cessation Rate at 12 Months
Proportion of patients who were able to completely discontinue proton pump inhibitor (PPI) therapy at 12 months after treatment. PPI cessation was defined as no regular use of PPI medications for at least 7 consecutive days prior to the 12-month assessment.
Time frame: 12 months after treatment
DeMeester Score Normalization at 12 Months
Proportion of patients who achieved normalization of the DeMeester score at 12 months after treatment. The DeMeester score is derived from 24-hour pH monitoring and a score below 14.7 was considered normal. Normalization indicates adequate control of acid reflux.
Time frame: 12 months after treatment
Operative duration
Duration of the surgical procedure.
Time frame: During the procedure in Minutes
Estimated Blood Loss
Estimated volume of blood lost during the surgical procedure. Unit of Measure: Milliliters (mL)
Time frame: During the procedure
Incidence of Intraoperative and Postoperative Complications
Incidence of patients who experienced any intraoperative or postoperative complication..." (e.g., bleeding, perforation, dysphagia, gas-bloat syndrome, need for reintervention). · Unit of Measure: Percentage of participants (or "Number of participants")
Time frame: From treatment until 12 months after treatment.
Complication Severity
Severity of complications classified according to the Clavien-Dindo classification system.
Time frame: · Time Frame: From treatment until 12 months after treatment.
Length of Hospital Stay
Duration of hospitalization following the surgical procedure.
Time frame: From Postoperative day 1 through 30 days after treatment.
Recurrence Rates
Proportion of patients who experienced recurrence of GERD symptoms or required reintroduction of PPI therapy or additional antireflux intervention after initial treatment success.
Time frame: 12 months after treatment
Routine Re-Endoscopy Findings at 6 Months (Esophagitis Assessment)
Presence and severity of esophagitis as assessed by routine upper gastrointestinal endoscopy.
Time frame: Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (Hiatal Hernia Assessment)
Presence and size of hiatal hernia as assessed by routine upper gastrointestinal endoscopy.
Time frame: · Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (wrap Integrity)
Assessment of wrap integrity (for Nissen fundoplication) via routine upper gastrointestinal endoscopy. Unit of Measure: Number of participants
Time frame: · Time Frame: 6 months after treatment.
Routine Re-Endoscopy Findings at 6 Months (Mucosal Healing)
Assessment of mucosal healing (for ARMA) via routine upper gastrointestinal endoscopy. · Unit of Measure: Number of participants.
Time frame: Time Frame: 6 months after treatment.
Treatment Success Rate
Proportion of patients who achieved treatment success, defined as a composite endpoint of at least 50% improvement in GERD-HRQL score, PPI cessation, and no need for repeat antireflux intervention at 12 months.
Time frame: 12 months after treatment
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