A LAparoscopic and TransAnal Total Mesorectal Excision (TME for Rectal Cancer Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Number of specimens with grade I specimen according to Quirke
研究概览
简要总结
All patients planned for an anterior resection due to rectal cancer with a total mesorectal excision are included. This is a feasibility study, thus no randomization will be performed.
Primary endpoint is clinical and pathologic examination of the specimen. Secondary end-points include clinical variables such as conversion rate, re-admission and/or re-operation due to any complication and health economy analyses.
详细描述
The design is comparative and prospective, we will compare specimens from patients operated at our institution during the last year with standard open or laparoscopic approach with patients operated with the new technique. Patients in the control arm will be patients operated prior to the commencement of the new technique or patients not eligible or possible to include in the study.
It is possible to obtain a macroscopically and microscopically adequate specimen after a combined approach with laparoscopic and transanal TME compared to open or laparoscopic conventional TME.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •presenting with a rectal cancer possible to operate with a total mesorectal excision and an anastomosis according to the local multidisciplinary conference
- •possible to operate with laparoscopic technique
- •possible to operate in regard to concomitant disease
- •giving informed consent to participate
排除标准
- •Participation in other trials in conflict with the protocol and end-points the LATA-trial
结局指标
主要结局
Number of specimens with grade I specimen according to Quirke
时间窗: 4 weeks postoperatively
Comparison with control group
次要结局
- Conversion rate(day of surgery)
- Re-admission(30 days)
- Postoperative complications scored according to Clavien-Dindo within the first 12 months(12 months)
研究者
Eva Angenete
Senior Consultant Surgeon, Associate professor
Sahlgrenska University Hospital, Sweden