Side-to-end Anastomosis Versus Colon J Pouch for Reconstruction After Low Anterior Resection for Rectal Cancer (SAVE)
试验速览
- 阶段
- 不适用
- 入组人数
- 306
- 试验地点
- 1
- 主要终点
- Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score)
研究概览
简要总结
Primary hypothesis: Side-to-end anastomosis is non-inferior to colon J pouch for reconstruction after low anterior resection for rectal cancer in fecal incontinence (Wexner score).
Research questions: Are there differences between side-to-end anastomosis and colon J pouch in
- bowel function (fecal incontinence, frequency of bowel movements, rectal urgency, incomplete evacuation)
- quality of life
- sexual function
- urinary function
- postoperative complications
- operation time/ institutional costs
详细描述
Experimental intervention: Low anterior resection for rectal cancer < 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon (3-5 cm long) is closed with a linear stapler. Stapling of the anastomosis is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The anastomosis is performed on the antimesenteric aspect of the descending colon. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
Control intervention: Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery close to the aorta, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling with a defined pouch limb length of 5-6 cm, which is measured intraoperatively. The stapling is done by introducing the stapler from the anus by the assistant surgeon while the surgeon is holding the descending colon in the correct position. The integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
Follow-up per patient: 24 months postoperatively
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with histological proven middle to low rectal cancer (< 12 cm from the anal verge) requiring low anterior resection with TME
- •with or without (neo)-adjuvant radiochemotherapy
- •age ≥18 years
- •normal preoperative sphincter status (Wexner score = 0)
排除标准
- •synchronous metastasis
- •age > 80 years
- •previous colon resection
- •inflammatory bowel disease
- •previous pelvic malignant tumor
- •no anterior resection/ TME possible
- •synchronous other malignant disease
- •emergency operation
- •local excision by colonoscopy possible
- •unability to complete or comprehend the preoperative questionnaire
研究组 & 干预措施
colon j pouch
Control intervention: Low anterior resection for rectal cancer with total mesorectal excision (TME), ligation of the inferior mesenteric artery, mobilization of the splenic flexure, radical lymph node dissection and colon J pouch rectal/colon J pouch anal anastomosis (CJP). The colon J Pouch is formed by the descending colon by stapling. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
干预措施: colon j pouch (Procedure)
side-to-end anastomosis (STE)
Experimental intervention: Low anterior resection for rectal cancer < 12 cm from the anal verge with total mesorectal excision (TME), ligation of the inferior mesenteric artery, mobilization of the splenic flexure, radical lymph node dissection and side-to-end colorectal/ coloanal anastomosis (STE). The blind end of the descending colon is closed with a linear stapler. The length of the blind end is measured and the integrity of the anastomosis is tested intraoperatively. The intended minimal distal clearance margin from the tumor is 2 cm. A protective loop ileostomy will be performed regularly which is intended to be closed 3 months postoperatively.
干预措施: side-to-end anastomosis (Procedure)
结局指标
主要结局
Side-to-end anastomosis is not inferior not colon J pouch in terms of fecal incontinence. fecal incontinence (Wexner score)
时间窗: First patient in to last patient out: 03/2010 -03/2015
次要结局
- anorectal function(03/2010-03/2015)
- quality of life(03/2010-03/2015)
- postoperative complications(03/2010-03/2015)
- sexual function(03/2010-03/2015)
- urinary function(03/2010-03/2015)
- operation time(03/2010-03/2015)
- institutional costs(03/2010-03/2015)
- local recurrence(03/2010-03/2015)
- cancer related deaths(03/2010-03/2015)