Evaluation of Minimally Invasive Bariatric Surgery Using a Single Laparoscopic Trocar (Single Incision of 2.5 to 3 cm) Versus 4 to 7 Trocars in Sleeve Gastrectomy
试验速览
- 阶段
- 不适用
- 入组人数
- 332
- 试验地点
- 2
- 主要终点
- Complication rate
研究概览
简要总结
Demonstrate non-inferiority of the single port for sleeve gastrectomy compared to the reference method in terms of complications using a score of morbidity and mortality at 6 and 24 months: Rate of fistula, intra and extra abdominal abcess, hemorrhage, gastric stenosis, splenic lesions, hernia, residual gastric pouch and mortality
详细描述
The single port surgery is the natural evolution of laparoscopy. To date only few studies have evaluated the feasibility of this technique in sleeve gastrectomy. The investigators want to demonstrate the non-inferiority in terms of morbidity-mortality of use single trocar in sleeve gastrectomy compared the multiport technique. Moreover it should highlight the non-inferiority in terms of anatomical quality, reduction of excess weight lost, reduction of comorbidities, decrease post operative pain, improved quality of life and evaluate medico-economic impact of these technique to validating this new surgical approach for bariatric surgery. The study will be multicentric with 6 university center (Montpellier, Amiens, Lille, Creteil, Poissy and Montsouris Institut). 388 patients will be included in the tow group of the prospective randomise study.
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
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
- •BMI> 35 kg/m2 with comorbidity (s) or> 40 kg/m2
- •Patients aged 18 to 65 years
- •Discussion and decision sleeve gastrectomy multidisciplinary meeting
- •Free, informed and written consent
- •Affiliation to a social security or other assurance
- •Exclusion Criteria - Anesthetics
排除标准
- •Uncontrolled severe infection
- •Liver disease other than obesity pathology
- •Pregnancy (positive hCG)
- •Large hiatal hernia
- •Esophagitis uncontrolled
- •History of gastric bypass and gastric surgery other than gastric banding
- •Saving Justice guardianship
- •Participation in another ongoing study
- •Cognitive or severe mental illness
- •Severe and non-stabilized eating disorders
- •Addiction to alcohol and psychoactive substances"
结局指标
主要结局
Complication rate
时间窗: up to 24 months
The principal criteria of analysis will be a score of morbidity and mortality at 24 months including: rate of fistula and intra-abdominal abscesses, the bleeding rate, the rate of gastric stenosis, rate splenic lesions, residual pouch or parietal damage (abscesses, incisional hernia, hematoma, delayed wound healing), and death
次要结局
- Reduction of excess weight by measuring BMI in kg / m2 pre-and postoperatively(up 3, 6, 12 and 24 months)
- Complication rate(up 3, 6, 9, and 12 months)