Internal Hernia After Laparoscopic Gastric Bypass
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,507
- 试验地点
- 2
- 主要终点
- Surgery for small bowel obstruction after a LGBP procedure.
研究概览
简要总结
To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.
详细描述
When the patients who has undergone a Laparoscopic Gastric Bypass lose weight, the mesenteric defects that are inevitable to cause, gets bigger and can cause an internal hernia (IH). This study will observe whether it is better to close the defects or leave them open. The patients will be randomized into two groups. One, where the defects are closed with sutures and one where the defects are left alone. The primary endpoint of the study is the prevalence of surgery for obstruction. Information about this will be gathered through the national register for obesity surgery in Sweden, SOReg. Each arm in the study will include 1200 patients and the follow up period will be three years. Since the register mentioned above is an ongoing register, the results can be studied over a longer period if wanted. The national hospital registry will further improve the follow-up.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent
排除标准
- •Conversion to open surgery prior to the randomization
- •Patients not giving a written consent
结局指标
主要结局
Surgery for small bowel obstruction after a LGBP procedure.
时间窗: 2 years
次要结局
- Serious Complications(within 2 years after surgery)
研究者
Erik Stenberg, MD
MD
Region Örebro County
