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NCT Number: NCT07842354

Antireflux Mucosal Ablation vs Fundoplication for Refractory GERD

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.

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Key information

Conditions

Antireflux Mucosal Ablation Deglutition Disorders Digestive System Diseases Endoscopic Therapy Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Laparoscopic Fundoplication Procedure Refractory GERD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of medicine

Minya, Minya Governorate, 61611, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Antireflux Mucosal Ablation (ARMA)

Procedure

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 Nissen fundoplication

Procedure

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.

Primary outcomes

  1. GERD-Health Related Quality of Life (GERD-HRQL) Score at 12 Months

    Time frame: Baseline and 12 months after treatment

    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.

  2. Proton Pump Inhibitor (PPI) Cessation Rate at 12 Months

    Time frame: 12 months after treatment

    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.

  3. DeMeester Score Normalization at 12 Months

    Time frame: 12 months after treatment

    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.

Secondary outcomes

  1. Operative duration

    Time frame: During the procedure in Minutes

    Duration of the surgical procedure.

  2. Estimated Blood Loss

    Time frame: During the procedure

    Estimated volume of blood lost during the surgical procedure. Unit of Measure: Milliliters (mL)

  3. Incidence of Intraoperative and Postoperative Complications

    Time frame: From treatment until 12 months after treatment.

    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")

  4. Complication Severity

    Time frame: · Time Frame: From treatment until 12 months after treatment.

    Severity of complications classified according to the Clavien-Dindo classification system.

  5. Length of Hospital Stay

    Time frame: From Postoperative day 1 through 30 days after treatment.

    Duration of hospitalization following the surgical procedure.

  6. Recurrence Rates

    Time frame: 12 months after treatment

    Proportion of patients who experienced recurrence of GERD symptoms or required reintroduction of PPI therapy or additional antireflux intervention after initial treatment success.

  7. Routine Re-Endoscopy Findings at 6 Months (Esophagitis Assessment)

    Time frame: Time Frame: 6 months after treatment.

    Presence and severity of esophagitis as assessed by routine upper gastrointestinal endoscopy.

  8. Routine Re-Endoscopy Findings at 6 Months (Hiatal Hernia Assessment)

    Time frame: · Time Frame: 6 months after treatment.

    Presence and size of hiatal hernia as assessed by routine upper gastrointestinal endoscopy.

  9. Routine Re-Endoscopy Findings at 6 Months (wrap Integrity)

    Time frame: · Time Frame: 6 months after treatment.

    Assessment of wrap integrity (for Nissen fundoplication) via routine upper gastrointestinal endoscopy. Unit of Measure: Number of participants

  10. Routine Re-Endoscopy Findings at 6 Months (Mucosal Healing)

    Time frame: Time Frame: 6 months after treatment.

    Assessment of mucosal healing (for ARMA) via routine upper gastrointestinal endoscopy.

    · Unit of Measure: Number of participants.

  11. Treatment Success Rate

    Time frame: 12 months after treatment

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 25, 2026
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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