Pelvic Floor Reconstruction (PR) in Endoscopic Low Anterior Resection for Rectal Cancer
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer
研究概览
简要总结
The anastomotic leakage remains the major early complication after laparoscopic anterior resection(LAR) for medium & low rectal cancer. Pelvic floor reconstruction (PR) is a key step in various standard resections for open radical rectal cancer surgery, which was considered to be helpful for decreasing the rate of leakage. However, PR in endoscopic LAR surgery is not routine practice and remains controversial. The purpose of this study is to evaluate the efficacy of PR during LAR for mid/low rectal carcinoma, especially in preventing anastomotic leakage.
详细描述
Eligible patients with rectal cancer will be randomly assigned to group with pelvic floor reconstruction(PR) versus group without pelvic floor reconstruction(NPR).
We want to investigate the rate of anastomotic leakage and re-operation between the two groups, some other relevant outcomes will be concerned all the same.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •patients with histologically proven rectal adenocarcinoma
- •tumor located in the middle and lower rectum and anastomosis under the peritoneal reflection
- •Tumor assessed as a depth of invasion that was confined to pT1-pT3, bN0-1M0 by ultrasound colonoscopy and/or pelvic MRI
- •Negative circumferential resection margin confirmed by MRI
- •Performance status (ECOG) 0~1
- •Written informed consent for participation in the trial
排除标准
- •History of accepting lower abdominal surgery.
- •More than one colorectal tumor
- •Patients with unresectable distant metastasis or multiple metastases
- •Received neoadjuvant radiotherapy before surgery
- •Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery
- •Patients and/or family members cannot understand and accept this study
- •Non-rectal adenocarcinoma was confirmed by postoperative pathological examination
结局指标
主要结局
The rate of anastomotic leakage after laparoscopic anterior resection for rectal cancer
时间窗: 30 days after surgery
Re-operation rate after anastomotic leakage
时间窗: 30 days after surgery
The rate of general complications
时间窗: 30 days after surgery
次要结局
- 3-year local recurrence rate(From date of operation until the date of local-recurrence (up to 3 years))
- White blood cells(WBC) ,C-reactive protein (CRP) and procalcitonin (PCT) count in the blood sample(5 days after surgery)
- Operative time(Operation day)
- Postoperative hospital stay(1 year after surgery)
- 5-year disease-free survival(From date of operation until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years)
- Postoperative quality of life as assessed by EORTC QLQ-C30 questionnaire(1 year after operation)
- Incidence of defecation dysfunction(From the date of operation until the date of complication,assessed up to 3 years)
- Blood loss(Operation day)
研究者
Li Chuan
Secretary of General Surgery
Southwest Hospital, China