Closing the Anastomoses During Laparoscopic Gastric Bypass Surgery: A Comparison of Traditional and Knotless Sutures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 主要终点
- Complication rate.
研究概览
简要总结
Background
Excess weight and obesity is the fifth leading risk factor for global death. Bariatric surgery is considered as the only effective long-term treatment for morbid obesity. Laparoscopic Roux-en-Y gastric bypass is one of the best surgical procedures, since it achieves excellent long-term results with a low complication rate. Intestinal anastomosis is a very complex and time-consuming procedure in laparoscopy, mainly due to the difficulties of knotting the suture in a limited working area. Barbed sutures may enhance this procedure by eliminating the need for knot tying.
Objective The aim of this study is to compare the safety and efficacy of knotless barbed sutures (Stratafix) and continuous sutures (Vicryl) for closing the gastrojejunal and jejunojejunal anastomosis in obese patients undergoing gastric bypass.
Study design
This is a prospective randomized study. Patients will be randomly assigned to one of two groups: traditional suture group or knotless suture group. Randomization will be realized by sealed envelopes according to a computer-generated sequence of random numbers, which will be opened for the surgeon just before starting the anastomosis. During the surgery the gastrojejunal and jejunojejunal anastomoses will be performed with a stapler (Echelon 45 Endopath) and closed with a traditional (Vicryl) or knotless (Stratafix Unidirectional) suture. The same surgeon, experienced and specialized in laparoscopic gastric bypass technique, will perform all procedures.
Study population
Two hundred patients undergoing laparoscopic Roux-en-Y gastric bypass.
Main study parameters/endpoints
The primary outcome measure will be the rate of anastomosis-related complications (leakage, bleeding, gastric fistula, anastomotic stenosis) at 4 weeks and at 6 months post-op (safety). The secondary outcome measure will be the time spent on closing the gastrojejunal and jejunojejunal anastomosis (efficacy).
详细描述
- INTRODUCTION AND RATIONALE
Obesity
Excess weight and obesity is the fifth leading risk factor for global death (WHO 2011). It has been demonstrated that conservative treatment of obesity, such as restricting calorie intake, increasing physical activity, and medical treatment, did not succeed in achieving significant long-lasting loss of weight (Flegal 2002). Therefore, bariatric surgery is considered as the only effective long-term treatment for morbid obesity to achieve substantial and sustainable weight loss (Fisher 2002).
Gastric bypass
Gastric bypass has a two-way effect: it restricts how much food the stomach can hold (restrictive) and it affects how food and calories are absorbed into the bloodstream (malabsorptive). This combination surgery has the highest success rate for amount of weight loss. Laparoscopic Roux-en-Y gastric bypass is one of the best surgical procedures, since it achieves excellent long-term results with a low complication rate (Schauer 2003, Suter 2011, Fisher 2002). During this procedure two anastomoses - gastrojejunal and jejunojejunal -are constructed. This can be achieved with handsewn suturing or with mechanical stapling (Gonzalez 2003). If the anastomoses are stapled with a linear technique, closing of the enterotomies with sutures is still required. This is a very complex and time-consuming procedure in laparoscopy, mainly due to the difficulties of knotting the suture in a limited working area (De Blasi 2013).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >18 years
- •BMI > 40 (morbid obesity) or BMI > 35 with co-morbidities (type 2 diabetes, proven sleep apnoea and/or refractory arterial hypertension)
- •Reasonable attempts at other weight loss techniques
- •Obesity related health problems
- •No psychiatric or drug dependency problems
- •Capable to understand the risks and commitment associated with the surgery
- •Pregnancy not anticipated in the first two years following surgery
排除标准
- •No agreement to informed consent
结局指标
主要结局
Complication rate.
时间窗: Up until 6 months after surgery.
Complications encountered postoperatively: leakage, stenosis, bleeding and gastric fistula.
次要结局
- Total procedure time.(intraoperative)
- Jejunojejunal anastomosis time.(intraoperative)
- Length of hospital stay.(Through study completion, an average of 3 days.)
- Gastrojejunal anastomosis time.(intraoperative)
研究者
Ben Gys
md
AZ St.-Dimpna Geel