Perioperative and Postoperative Evaluation of Rectal and Urogenital Function in Patients Undergoing Rectal Resection
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Rectal sphincter function before and after rectal resection
研究概览
简要总结
The aim of this study is the systematic analysis of the development of perioperative rectal and urogenital function in patients undergoing rectal resection with total mesorectal excision and the identification of risk factors for urogenital and sphincter function loss after this procedure. Knowledge of the corresponding risk factors could enable the identification of patient cohorts that could benefit from an intensified or altered postoperative treatment path. The results of this study could thus significantly influence the clinical management of patients with rectal cancer and improve the functional outcome in the long term.
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
- •Patients undergoing rectal resection with total mesorectal excision
排除标准
- •primary or secondary removal of rectal sphincter apparatus
- •patients with enterostomy persisting 12 months after initial rectal resection
结局指标
主要结局
Rectal sphincter function before and after rectal resection
时间窗: 5 years
Sphincter function will be assessed by manometry preoperatively and 12 - 24 months and 5 years postoperatively
Assessment of pelvic function before and after rectal resection
时间窗: 5 years
Rectal and urogenital function will be assessed preoperatively and 12-24 months and 5 years postoperatively using the PERIFUNC score questionnaire, resulting in a score between 0 and 120. Higher scores mean a worse outcome (worse pelvic function).
Assessment of stool continence before and after rectal resection
时间窗: 5 years
Stool continence will be assessed preoperatively and 12-24 months and 5 years postoperatively using the LARS score questionnaire, resulting in a score between 0 and 42. Higher scores mean a worse outcome (worse stool continence).
次要结局
- Operating time [min](during surgery)
- Duration of postoperative hospital stay [days](At day of discharge, assessed up to 90 days)
- Kind of peri-operative morbidity after resection(90 days after surgery)
- Intraoperative blood loss [mL](during surgery)
- Duration of postoperative intermediate/intensive care unit stay [days](At day of discharge, assessed up to 90 days)
- Frequency of peri-operative morbidity after resection(90 days after surgery)