Effects of Modified Precision Functional Sphincter-Preserving Surgery (PPS) on Ultralow Rectal Cancer: A Multicenter Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The percentage of patients who develop anastomotic leakage
研究概览
简要总结
RATIONALE: Colorectal cancer is one of the most common cancers. However, approaches to minimize surgical trauma, preserve anal function, avoid abdominal stoma, and improve quality of life for patients with ultralow rectal cancers were limited. Thus, new technologies are urgently needed to improve the anal preservation rate, reduce the incidence of anastomotic leakage and improve postoperative anal function in patients with ultralow rectal cancer.
PURPOSE: This one-arm multicenter prospective cohort study aims to collect the data of patients with ultralow rectal cancer who undergo sphincter-preserving surgeries, including modified PPS and conventional surgeries, then compare the effects of different operations on clinical outcomes and to see the efficacy and safety of modified PPS surgery when compared with conventional procedures in the treatment of ultralow 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
- •Histological proof of newly diagnosed primary adenocarcinoma of the rectum
- •The lower edge of tumor < 3 cm from the dentate line
- •Clinical T stage ≤ T3
排除标准
- •The lower edge of tumor < 1 cm from the dentate line
- •Locally advanced stage of tumor
- •Presence of metastatic disease or recurrent rectal tumor
- •Concomitant malignancies
- •Concurrent uncontrolled medical conditions
- •Impaired anal function before surgery
- •Presence of acute bowel obstruction or bowel perforation caused by cancer
- •Pregnancy or breast feeding
结局指标
主要结局
The percentage of patients who develop anastomotic leakage
时间窗: Within 30 days after operation
The percentage of patients who develop anastomotic leakage
Postoperative anal function assessed by Wexner scale
时间窗: 2 years since the start of treatment
Ranging from 0 (perfect continence) to 20 (complete incontinence)
Rate of temporary defunctioning stoma
时间窗: Within 30 days after operation
The percentage of patients who get temporary defunctioning stoma to limit the consequences of anastomotic leakage.
Postoperative anal function assessed by Vaizey scale
时间窗: 2 years since the start of treatment
Ranging from 0 (perfect continence) to 24 (complete incontinence)
次要结局
- Postoperative hospital stay(Within 30 days after operation)
- Hospitalization costs(Within 30 days after operation)
- 30-Day Readmission Rate(Within 30 days after operation)
- Disease-free survival(Up to 5 years after the last patient recruited)
- Overall survival(Up to 5 years after the last patient recruited)
- Rate of sphincter-preservation rates(Within 30 days after operation)
- The number of short-term postoperative complications(Within 30 days after operation)
研究者
Zhang Feng-Min
Investigator assistant
Shanghai 10th People's Hospital