A Prospective, Randomised Controlled Study To Compare Antral Resection Versus Antral Preservation During Laproscopic Sleeve Gastrectomy For Morbidly Obese
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- AIIMS
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Percent excess weight loss
研究概览
简要总结
Bariatric or Metabolic surgery has emerged as an effective and durable treatment for morbidly obese as it induces good weight loss,decreased comorbidities like Diabetes and hypertension and gives a better quality of life.
Laproscopic Sleeve gastrectomy is one of the type of various surgeries done for morbidly obese patients but there are various controversies regarding the operating technique such as the size of the bougie used, distance of pylorus from the staple line,reinforcement of staple line and use of intraoperative seal test.
Our study will deal with one of the debatable issue that is the distance of pylorus from staple line. Patient will be randomised in two groups i.e Antral preservation (5 cm from pylorus) and Antral resection (2cm from the pylorus) and the outcomes will be measured at 0, 3,6 and 12 months in terms of weight loss as primary outcome and comorbidity resolution , complication and gastric emptying time as secondary outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Includes accepted indications for bariatric surgery like 1.Body mass index (BMI) ≥ 40 kg/m2 or BMI ≥ 35 kg/m2 with atleast one co-morbidity associated with obesity (type 2 diabetes, hypertension, dyslipidemia, obstructive sleep apnea) 2.Age between 20 and 60years 3.Failure of conservative treatment over2 years.
排除标准
- •1.Significant GERD symptoms 2.Erosive esophagitis on UGIE 3.Poorly controlled significant medical or psychiatric disorders 4.Active alcohol or substance abuse 5.Active duodenal/gastric ulcer disease 6.Previous major gastrointestinal surgery 7.End-stage organ disease.
结局指标
主要结局
Percent excess weight loss
时间窗: 3, 6 and 12 months
次要结局
- 1.Gastric emptying time(2.GERD symptoms)