Exploring the Effect of Applying Colonic J-pouch Forming in Anorectal Preservation Surgery for Ultra-low Rectal Cancer on Postoperative Bowel Control Function
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- LARS score
研究概览
简要总结
The occurrence of colorectal cancer has increased from the third most common cancer in 2018 to the second most common cancer in 2023. The practice of anal preservation surgery for ultra-low rectal cancer is being adopted gradually. Ultra-low rectal cancer patients who have undergone anal preservation are at an increased risk of developing significant bowel complications. The objective of this study was to examine the relationship between the type of bowel reconstruction following anal preservation surgery, and the subsequent outcomes of bowel function, quality of life and complication rates in patients with ultra-low rectal cancer.
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
- •A confirmed diagnosis of intestinal cancer, with the lower edge of the tumour <5 cm from the anus or <3 cm from the dentate line, and treated with anus-preserving surgery;
- •No distant metastasis;
- •Age >18 years old;
- •Voluntary enrollment in the study and signing of an informed consent.
排除标准
- •A combination of severe cardiopulmonary, hepatic, renal, and other underlying diseases with a greater anaesthetic risk (ASA ≥ grade 4);
- •preoperative anal stenosis and anal nonfunction;
- •temporary stoma diversion.
结局指标
主要结局
LARS score
时间窗: From 1 month postoperatively to 12 months postoperatively
The LARS scale has five questions with a total score of 42. A score of 0-20 lacks diagnostic value for LARS, while a score of 21-29 indicates mild LARS and a score above 29 indicates major LARS.
FIQL
时间窗: From 1 month postoperatively to 12 months postoperatively
The FIQL is a specific quality-of-life assessment scale applicable to the symptoms of colorectal cancer patients. It comprises 29 items, which are divided into four dimensions: lifestyle (10 items), coping/behavior restriction(9 items), depression/self-perception (7 items), and embarrassment (3 items).
Vaizey score
时间窗: From 1 month postoperatively to 12 months postoperatively
The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.
Wexner score
时间窗: From 1 month postoperatively to 12 months postoperatively
The Wexner scale has five parts with a total score of 20, while the Vaizey scale is further refined on the basis of Wexner and has seven parts with a total score of 24. Higher scores on these scales indicate poorer anal functioning.
次要结局
- Surgical complications(From 1 month postoperatively to 12 months postoperatively)
研究者
Zhang Feng-Min
Principal Investigator
Shanghai 10th People's Hospital