Laparoscopic Gastric Bypass Versus Laparoscopic Banded Gastric Bypass, a Randomized Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Postoperative complications at 10 years
研究概览
简要总结
This study try to identify differences in length of operation, weight loss and complications, between two different bariatric surgical techniques, the laparoscopic Roux-en-Y gastric bypass and the laparoscopic Roux-en-Y banded gastric bypass. The study will be conducted in a Spanish public health system hospital. The patients of the trial will have the preoperative studies, hospital treatment during the admission, postoperative treatment and follow up as any other patient included in the hospital bariatric surgery program. The study cases will have placed around the gastric pouch a band of polypropylene mesh, and will be randomly choose between the participants.
Patients will be randomized in a 5/3 (study/control) ratio.
详细描述
One group of patients of the study will have done the simplified laparoscopic gastric bypass, with a vertical gastric pouch of about 20 ml, a 150 cm Roux-en-Y limb constructed in an antegastric antecolic fashion, and a biliary limb of 100 cm. Anastomosis will be done with endoscopic surgical linear stapler, closing the apertures with continuous absorbable running sutures. The Petersen space and the mesenteric defect will be closed with non-absorbable sutures.
The other group of patients will have performed the laparoscopic Roux-en-Y banded gastric bypass. This technique is identical to the one performed in the other group, but differs in that a polypropylene mesh (10x65 mm) is placed 15 mm proximal to the anastomosis around the gastric pouch, and the gastric pouch is about 15 mm longer.
The investigators randomly assigned 50 patients to the study group (Laparoscopic Roux-en-Y banded gastric bypass) and 30 to the control group (Laparoscopic Roux-en-Y gastric bypass) , n=80, and were also blinded to the surgeon until surgery.
One of the methods is basically the same than the other, but for the placement of the polypropylene mesh around the gastric pouch above the anastomosis, and patient series with Laparoscopic Roux-en-Y banded gastric bypass showed long term better weight loss than other series with not banded gastric bypass, thus it is expected a difference in long term weight loss between groups.
Fisher Test will be used for the statistical analysis, assuming a risk of 0.05 and a statistical power of 90%.
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
- Single (Participant)
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
- •criteria for bariatric surgery published in 1991 for the National Institutes of Health of the USA.
- •Body mass index (BMI)> 40 and <55 kg/m2
- •Obesity for more than 5 years of evolution
- •Fail in medical supervised weight loss program
- •patient knowing of the mechanism of weight loss after surgery and agreement to collaborate with medical recommendations, diet, medical treatment, as well as the visit established in the follow up program
- •patient accepting that surgery objective is not to achieve the ideal weight.
- •signed specific informed consent
- •women will agree in avoid gestation during one year after surgery
排除标准
- •Patients unable to sign the informed consent form because of a mental disorder.
- •endocrine diseases causing obesity
- •unstable mental disorder, evaluated for a psychiatry MD.
- •high anesthetic risk making surgery too risky.
- •Malignant neoplasm
- •Inflammatory bowel disease
- •Severe liver disease
- •Digestive disease that makes unwise the bypass technique (mainly gastric illness that may required upper endoscopy for control)
- •abdominal wall hernias
- •Symptomatic biliary pathology that requires cholechistectomy at the same time of the bariatric surgery
- •any known pathology that requieres or recomend simultaneous surgery at the time of the bariatric surgery.
结局指标
主要结局
Postoperative complications at 10 years
时间窗: 10 years
Number of participants with adverse events (surgical complications) and/or abnormal Laboratory values that are related to treatment
Change from operation date, in excess weight loss at 10 years
时间窗: 10 years
% of excess weight loss at 10 years
次要结局
- Total Hospital cost at 3 months(up to 3 months)
- Excess weight loss at 5 years(5 years)
- Postoperative complications 2 years(2 years)
- Postoperative complications 3 years(3 years)
- Postoperative complications 1 year(1 year)
- Postoperative complications 5 years(5 years)
研究者
Miguel J. Garcia-Oria
MD, PhD
Puerta de Hierro University Hospital