Evaluation of Possible Postoperative Complications After Nissen Sleeve Gastrectomy. French Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Study postoperative morbidity after nissen sleeve gastrectomy in Nantes
研究概览
简要总结
The purpose of this study is to evaluate the impact about complications between the procedure (sleeve gastrectomy technique with a Nissen fundoplication (N-Sleeve)) and conventional sleeve gastrectomy technique
详细描述
Obesity is currently a major health problem. 2% of the French adult population is morbidly obese (BMI>40kg/m²). In this case, the only effective treatment is bariatric surgery. More than 50,000 acts of bariatric surgery were performed in 2018 in France. Three main operations are considered: Sleeve Gastrectomy (SG), Roux en Y Gastric Bypass (RYGB) and Gastric Banding.
SG was validated by the Haute Autorité de Santé (HAS) in 2008 and is the most widely used procedure in France (35,580 operations in 2018). It consists of a 2/3 partial gastrectomy. Long-term weight loss of 61 ± 23% is expected, with significant improvement in obesity-related comorbidities.
However, this technique is associated with postoperative complications. Gastric fistula (2%), most often located at the upper end of the stapling line, bleeding from the gastric section (2%) and gastric stenosis (1%) are the most frequent early postoperative complications that may require reoperation. In addition, gastroesophageal reflux disease (GERD) is very common (30-57%), and can have serious consequences for the esophageal mucosa (esophagitis, Barrett's esophagus, cancer). Alarmingly high rates of Barrett's esophagus (17-18%) after SG have recently been described in the long term, causing concern in the medical community. This may be an exacerbation of preoperative GERD symptoms or "de novo" postoperative GERD. Medical treatment is generally effective (proton pump inhibitors (PPIs)). However, the long-term safety of PPIs has not been demonstrated. What's more, these patients' quality of life may be considerably reduced, and re-intervention (gastric Y-bypass) may be necessary to treat refractory GERD.
The classic surgical treatment for GERD, independently of bariatric surgery, is fundoplication, which can be partial (180°: Toupet technique) or total (360°: Nissen technique). The gastric fundus is wrapped around the esophagus to reinforce the esophageal sphincter.
Nissen-Sleeve Gastrectomy (Nissen-SG) is an innovative technique performed in expert centers in France. It consists in creating a total anti-reflux fundoplicature (Nissen) before performing a SG.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •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).
- •Previous reflux surgery
- •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.
- •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
Study postoperative morbidity after nissen sleeve gastrectomy in Nantes
时间窗: 30 days post operation
Collection of complications at 30 days post-op (aphagia, valve necrosis, fistula, etc.) and classification according to Dindo-Clavien.
postoperative morbidity of nissen sleeve gastrectomy with sleeve gastrectomy in France
时间窗: 30 days post operation
Comparison of Nissen Sleeve Gastrectomy data at 30d post-op (aphagia, valve necrosis, fistula...) with published PMSI sleeve gastrectomy data.
次要结局
未报告次要终点