Defunctioning Left-sided Colostomy in Low Anterior Resection for Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Low anterior resection syndrome (LARS)
研究概览
简要总结
This is prospective, multi centre study evaluating a novel type of defunctioning loop stoma after low anterior resection for rectal cancer. Patients will be operated with a complete splenic flexure mobilisation and total mesorectal excision. An anastomosis will be fashioned at the pelvic floor. This will leave a redundant colon which will be brought up and matured in the left iliac fossa. Patient bowel function and quality of life will be monitored at baseline and at one year postoperatively, when the stoma will typically have been reversed. Dehydration and kidney injury are expected to become infrequent in comparison with the main alternative loop ileostomy. About 20 patients will be included in this pilot study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Age ≥18 years
- •Capacity for informed consent
- •Planned defunctioning stoma
- •Planned mesorectal excision with anastomosis for rectal cancer
排除标准
- •Manifest atherosclerotic disease (peripheral vascular disease, previous myocardial infarction, angina, etc)
- •Previous oncological colonic resection
- •Defunctioning stoma in situ
- •Intraoperative event leading to bowel resection and subsequent inability to bring out left-sided colostomy without tension on the anastomosis
- •Intraoperative circumstances as judged by the operating surgeon leading to unacceptable risks due to loop colostomy placement (abdominal wall size, short mesentery, other preconditions)
研究组 & 干预措施
Left-sided loop colostomy
Left-sided loop colostomy matured in left iliac fossa after complete splenic flexure mobilisation, mesorectal excision and anastomosis
干预措施: Defunctioning left-sided loop colostomy (Procedure)
结局指标
主要结局
Low anterior resection syndrome (LARS)
时间窗: 1 year
Rate of major LARS (score 31-42) as measured by the LARS questionnaire, which assesses bowel dysfunction.
次要结局
- Bowel ischaemia(30 days)