Monocentric Prospective Randomized Controlled Study Comparing the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique (N-Sleeve) in Morbidly Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Presence of gastroesophageal reflux disease
研究概览
简要总结
The purpose of this study is to evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique
详细描述
Bariatric surgery is recognized as the only effective therapeutic weapon for morbidly obese patients. Gastro-Oesophageal Reflux Disease is very common (30-45% of cases) with serious consequences on the oesophageal mucosa. It could be an exacerbation of preoperative GERD symptoms or a "de novo" postoperative GERD. Medical treatment is usually effective but reoperation may be required to treat refractory GERD.GERD can lead to serious consequences on the oesophageal mucosa (esophagitis, Barrett's oesophagus, cancer). The conventional surgical treatment of GERD is fundoplication, which can be partial or total. The gastric fundus is wrapped around the oesophagus to strengthen the tone of the oesophageal sphincter. We hypothesize that the creation of a total anti-reflux fundoplication before performing LSG (Nissen + Sleeve = N-sleeve) could significantly reduce the postoperative GERD complication as compared with the standard LSG.
To evaluate the impact of the procedure N-Sleeve vs conventional sleeve gastrectomy technique on the rate of patient with GERD at 1, 6 and 12 months postoperatively. To evaluate the impact of the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve) vs conventional sleeve gastrectomy technique during all the follow-up on the gastric fistula on the staple line, on the postoperative morbidity and mortality , on the evolution of weight loss, the excess weight loss, the BMI and the excess BMI loss during the follow-up. Evaluate the impact of these procedures on the quality of life of patients at baseline and 1, 6 and 12 months postoperatively. Evaluate the safety during all the follow-up.
•Methods: Monocentric, randomized, single-blind controlled trial, with 2 parallel arms. 144 patients. The target population is all adult patients with severe or morbid obesity, who underwent multidisciplinary care and having the criteria of 2009 HAS recommendations for bariatric surgery.
Presence of gastro-oesophageal reflux will be assessed by a composite criteria: consumption of Proton Pump Inhibitor and gastroscopy at baseline and 12-month.
The N-SLEEVE technique consists of creating a gastric total fundoplication before to perform the removal of 2/3 of the stomach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Signed informed consent form
- •Subjects must be able to attend all scheduled visits and to comply with all trial procedures
- •Subjects must be covered by public health insurance
- •Contraception efficacy
- •Subjects eligible for sleeve gastrectomy after multidisciplinary evaluation according to HAS 2009 criteria: BMI ≥ 40 kg / m² with failure of the dietary treatment for at least 1 year, or a BMI ≥ 35kg / m² with at least one co-morbidity that could be improved after surgery (hypertension, obstructive sleep apnea hypopnea syndrome (OSAHS) and other severe respiratory disorders, severe metabolic disorders (especially type 2 diabetes), debilitating musculoskeletal diseases, non-alcoholic steato-hepatitis (NASH))
排除标准
- •Subject unable to read or/and write
- •Planned longer stay outside the region that prevents compliance with the visit plan
- •Current pregnancy
- •Previous bariatric surgery (ring, vertical banded gastroplasty, sleeve gastrectomy or Gastric Bypass).
- •BMI > 50 kg / m² for women and > 45kg / m² for men (dissecting the hiatus region can be a technical challenge in these cases).
- •Barrett oesophagus and esophagitis stage III and IV.
- •Long-term NSAIDs and/or corticosteroid therapy
- •No affiliation at the French social security scheme.
- •Major protected by law.
- •Deprivation of liberty by judicial or administrative decision.
- •Participation to another clinical research program.
结局指标
主要结局
Presence of gastroesophageal reflux disease
时间窗: 12 months
Gastroscopy is a standard endoscopic examination that examines the lining of the oesophagus and stomach. It can detect Helicobacter pylori and highlight the presence of: * Gastro-Oesophageal Reflux Disease * Gastritis * Esophagitis * Barrett's oesophagus * Hiatal hernia * Gastric tumor * Bile reflux * Incompetent cardia
Consumption of Proton Pump Inhibitor
时间窗: 12 months
The consumption of PPI, revealing the presence of GERD symptoms, will be recorded at each visit thanks a diary card.
次要结局
- Postoperative morbidity Month 12(Month 12)
- type of fistula Month 6(Month 6)
- type of fistula Month 12(Month 12)
- severity of fistula Month 12(Month 12)
- Weight loss Month 1(Month 1)
- Postoperative morbidity Month 1(Month 1)
- severity of fistula Month 1(Month 1)
- mortality Month 1(Month 1)
- type of fistula Month 1(Month 1)
- severity of fistula Month 6(Month 6)
- Quality of Life Month 1 : SF 12(Month 1)
- Quality of Life Month 6 : SF 12(Month 6)
- Quality of Life Month 12 : SF 12(Month 12)
- Postoperative morbidity Month 6(Month 6)
- Weight loss Month 6(Month 6)
- Weight loss Month 12(Month 12)
- mortality Month 6(Month 6)
- mortality Month 12(Month 12)
- Serious adverse event Month 1(Month 1)
- safety Month 12: number and type of adverse events(Month 12)
- safety Month 6: number and type of adverse events(Month 6)