Comparison of Postoperative Anal Function Between Different Anastomosis Techniques(Parks Versus Bacon) in Low Rectal Cancer: A Prospective, Multicentric and Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Low Anterior Resection Syndrome (LARS) score 1 year after surgery
研究概览
简要总结
The goal of this study is to compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life.
The main questions it aims to answer are: the difference of anal function 1 year after surgery type of study: clinical trial participant population: patients with low rectal cancer Participants will receive Parks operation of Bacon operation If there is a comparison group: Researchers will compare Parks and Bacon operation to see if the anal function 1 year after surgery is different.
详细描述
objective
To compare the postoperative anal function of patients with ultra-low rectal cancer after Parks operation (colon anal anastomosis) and Bacon operation (colon anal pull-out anastomosis), which may provide clinical evidence for the improvement of anal function and quality of life.
primary outcome: Low Anterior Resection Syndrome (LARS) score 1 year after surgery secondary outcomes: 1. LARS score at 3 months after surgery 2. LARS score at 6 months after surgery 3. Postoperative Quality of Life Score 4. The incidence of postoperative anastomotic complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women, aged between 18 and 75 years;
- •Pathological diagnosis of rectal cancer before operation, with the distance from the lower edge of the tumor to the dentate line ≤ 3cm by MR imaging;
- •No local complications (including complete/ incomplete obstruction, active bleeding, local invasion of sphincter or levator ani, etc.) before operation;
- •Suitable for anal preservation surgery discussed by MDT;
- •Adequate bone marrow, liver, renal and cardiac function meeting the requirements of surgery and anesthesia;
- •R0 resection is expected technically;
- •Provision of written informed consent.
排除标准
- •Previous history of malignant colorectal tumors;
- •Complications such as obstruction and gastrointestinal bleeding that need an emergency operation;
- •Unachievable R0 resection due to invasion of adjacent organs by primary tumor;
- •Multiple primary tumors;
- •History of other malignancy;
- •Participation in other clinical trials within the previous 4 weeks of enrollment;
- •ASA physical status score ≥ IV level and/or ECOG performance status ≥ 2;
- •Intolerance of surgery due to liver, renal, cardiopulmonary or coagulation dysfunction, or underlying diseases;
- •History of serious mental disorders;
- •Women in pregnancy or lactation period;
- •Uncontrolled infection before operation;
- •Unsuitable to be included due to other clinical and laboratory conditions by the judgement of investigators.
结局指标
主要结局
Low Anterior Resection Syndrome (LARS) score 1 year after surgery
时间窗: 1 year after surgery
use a scoring system for bowel dysfunction after LAR for rectal cancer on the basis of symptoms and impact on quality of life
次要结局
- LARS score at 6 months after surgery(6 months after surgery)
- The incidence of postoperative anastomotic complications(3, 6, and 12 months after operation)
- Postoperative Quality of Life Score(3, 6, and 12 months after operation)
- LARS score at 3 months after surgery(3 months after surgery)