Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Transanal specimen extraction possible or not
研究概览
简要总结
Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.
详细描述
Primary endpoint:
To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.
Secondary endpoints:
- quality of life 6 months after surgery
- continence 6 months after surgery
- pain postoperative
- complication rate
- duration of procedure
- lengh of stay
Hypothesis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •benign indication for left sided colectomy
排除标准
- •age below 18 years
- •unable to understand informed consent of missing informed consent
- •emergency surgery
结局指标
主要结局
Transanal specimen extraction possible or not
时间窗: at surgery
Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.
次要结局
- continence 6 months postoperative(6 months postoperative)
- quality of life(6 months postoperative)
- Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)(up to 6 weeks postoperative)
研究者
Daniel Steinemann, MD
Principle Investigator
Cantonal Hosptal, Baselland