The SLEEVE-GERD Trial: A Comparative Study of Nissen-Sleeve and Roux-en-Y Gastric Bypass in Obese Patients With GERD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 560
- 试验地点
- 2
- 主要终点
- GERD Symptom Remission
研究概览
简要总结
This randomized clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y Gastric Bypass (RYGB), which is the current standard surgical option for obese patients with GERD.
Both procedures are widely used to treat severe obesity, but they differ in how they affect the digestive system and the potential for reflux control, nutritional outcomes, and future surgical options. N-SG is a newer technique that preserves the natural pathway of the gastrointestinal tract and allows standard endoscopic access to the bile ducts, which may be beneficial for long-term patient care. RYGB, on the other hand, bypasses part of the stomach and small intestine, which may lead to better reflux resolution but carries risks of nutritional deficiencies and altered anatomy.
Eligible participants with obesity and GERD symptoms will be randomly assigned to receive either N-SG or RYGB. The primary goal is to evaluate whether N-SG is not inferior to RYGB in reducing GERD symptoms one year after surgery. Secondary outcomes include weight loss, quality of life, surgical complications, and changes in the hormone ghrelin, which is involved in appetite regulation.
In addition, a larger control group of patients without GERD undergoing standard sleeve gastrectomy will be recruited to allow further comparisons. All participants will be followed for one year after surgery, with blood samples, questionnaires, and clinical data collected to assess both metabolic and reflux-related outcomes.
This study is being conducted at the University Hospital in Kraków, Poland, and aims to improve the personalization of bariatric treatment for patients suffering from both obesity and reflux.
详细描述
This randomized clinical trial is designed to compare the safety and effectiveness of Nissen-Sleeve Gastrectomy (N-SG) versus Roux-en-Y Gastric Bypass (RYGB) in patients with obesity and symptoms of gastroesophageal reflux disease (GERD). N-SG is a modified sleeve gastrectomy procedure that incorporates an anti-reflux mechanism based on the Nissen fundoplication technique, while RYGB is a well-established bariatric procedure with proven anti-reflux efficacy.
Background and Rationale:
Severe obesity (BMI ≥ 40 or ≥ 35 with comorbidities) is a growing health problem and is frequently associated with GERD. While sleeve gastrectomy (SG) is currently the most widely performed bariatric procedure globally, it has been associated with the development or worsening of GERD in a significant number of cases. RYGB has become the standard surgical approach in obese patients with pre-existing GERD due to its high rate of reflux symptom resolution. However, RYGB involves more complex anatomical changes, carries a risk of nutritional deficiencies, and limits future endoscopic access to the biliary tract.
The Nissen-Sleeve Gastrectomy (N-SG), first described by David Nocca in 2016, combines SG with a 360-degree gastric fundoplication wrap (similar to that used in traditional Nissen fundoplication). This technique preserves gastrointestinal continuity and potentially maintains endoscopic access to the duodenum, while adding a reflux barrier. Early observational studies suggest favorable outcomes in terms of GERD resolution while retaining the benefits of SG. However, no large-scale randomized controlled trial has compared N-SG with RYGB in this specific patient population.
Study Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study. Due to the nature of the surgical interventions, masking of participants and healthcare providers is not feasible. Both the patients and the surgical team are aware of the assigned intervention. Outcome assessors and data analysts will be blinded during statistical analysis to minimize potential bias.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For N-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms:
- •Age ≥ 18 years
- •Written informed consent provided
- •Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities)
- •Presence of symptomatic gastroesophageal reflux disease (GERD), defined by at least one of the following:
- •Regular use of proton pump inhibitors (PPIs)
- •GerdQ score > 6
- •Endoscopic evidence of esophagitis (Los Angeles classification grade B or higher)
- •For Sleeve Gastrectomy (SG) observational control group:
- •Age ≥ 18 years
- •Written informed consent provided
- •Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities)
- •No symptoms or history of GERD
排除标准
- •History of prior anti-reflux surgery
- •History of upper gastrointestinal tract surgery
- •Active smoking or history of nicotine use
- •Severe cardiac insufficiency (New York Heart Association Class III or IV)
- •Pregnancy or planned pregnancy during the study period (if applicable based on future additions)
- •Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the study protocol or would pose additional risk
结局指标
主要结局
GERD Symptom Remission
时间窗: 12 months post-surgery
Resolution of GERD symptoms, defined as: No need for proton pump inhibitors (PPIs) for at least 60 consecutive days, and GerdQ questionnaire score \< 7 at 12-month follow-up. Comparison between Nissen-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms.
次要结局
- Percent Excess Weight Loss (%EWL)(12 months post-surgery)
- Percent Total Weight Loss (%TWL)(12 months post-surgery)
- Change in Serum Ghrelin Levels(Baseline (day of surgery), postoperative day 1, day 7 after discharge, and 12 months post-surgery)
- Change in Body Mass Index (BMI)(Difference in BMI from baseline to 12 months. Compared across all three study arms.)
- Postoperative Complication Rate (Clavien-Dindo Classification ≥ Grade III)(Up to 30 days post-surgery)
- Quality of Life (QoL) Score(12 months post-surgery)
- GERD Related Quality of Life(12 months post-surgery)
研究者
Michał Pędziwiatr
Chair of Surgery Department
Jagiellonian University