Antireflux Mucosal Ablation Versus Laparoscopic Nissen Fundoplication for Refractory Gastroesophageal Reflux Disease: A Comparative Cohort Study of 200 Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- GERD-Health Related Quality of Life (GERD-HRQL) Score at 12 Months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
Laparoscopic Nissen Fundoplication Group
One hundred patients with refractory GERD who underwent laparoscopic Nissen fundoplication. Treatment allocation was protocol-driven and determined by a multidisciplinary team.
干预措施: Laparoscopic Nissen Fundoplication (Procedure)
Modified ARMA Group
One hundred patients with refractory GERD who underwent modified antireflux mucosal ablation (ARMA). Treatment allocation was protocol-driven and determined by a multidisciplinary team.
干预措施: Modified Antireflux Mucosal Ablation (ARMA) (Procedure)
结局指标
主要结局
GERD-Health Related Quality of Life (GERD-HRQL) Score at 12 Months
时间窗: 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.
Proton Pump Inhibitor (PPI) Cessation Rate at 12 Months
时间窗: 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.
DeMeester Score Normalization at 12 Months
时间窗: 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.
次要结局
- Operative duration(During the procedure in Minutes)
- Estimated Blood Loss(During the procedure)
- Incidence of Intraoperative and Postoperative Complications(From treatment until 12 months after treatment.)
- Complication Severity(· Time Frame: From treatment until 12 months after treatment.)
- Length of Hospital Stay(From Postoperative day 1 through 30 days after treatment.)
- Recurrence Rates(12 months after treatment)
- Routine Re-Endoscopy Findings at 6 Months (Esophagitis Assessment)(Time Frame: 6 months after treatment.)
- Routine Re-Endoscopy Findings at 6 Months (Hiatal Hernia Assessment)(· Time Frame: 6 months after treatment.)
- Routine Re-Endoscopy Findings at 6 Months (wrap Integrity)(· Time Frame: 6 months after treatment.)
- Routine Re-Endoscopy Findings at 6 Months (Mucosal Healing)(Time Frame: 6 months after treatment.)
- Treatment Success Rate(12 months after treatment)
研究者
Abdelrahman Mohamed Salah
Lecturer of General Surgery, Faculty of Medicine, Minia University, Minia, Egypt.
Minia University