Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Reduction in analgetic need
研究概览
简要总结
Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-90
- •Symptomatic recurrent diverticular disease
- •Benign adenomatous polyp, requiring surgery
- •Early non-transmural sigmoidtumor
- •Signed written informed consent, approved by ethical committee
排除标准
- •Patients unsuitable for laparoscopy
- •Pregnancy
- •ASA >III
- •Coagulation disorders
- •Anti-coagulants
结局指标
主要结局
Reduction in analgetic need
次要结局
- reduction in hospital stay within an ERAS-program
- effect on the inflammatory response
- effect on anal continence
- procedural cost assessment (incorporating operative time)
- overall cost assessment
