Evaluationof the Efficiency of a Resorbable Barrier Membrane for the Prevention of Abdominal and Peri-hepatic Adhesion in Patients With Colorectal Cancer Requiring Two-stage Surgery for the Resection of Hepatic Metastases
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 18
- 主要终点
- abdominal and peri-hepatic adhesion during the second operation
研究概览
简要总结
The purpose of this study is to evaluate the efficiency of a resorbable barrier membrane for the prevention of abdominal and peri-hepatic adhesion in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases.
Eligible patients will be randomly assigned to one of 2 arms:
- Seprafilm group (receiving resorbable barrier membrane during the first surgery)
- No-treatment control group (without seprafilm barrier during the first surgery)
The primary objective is to establish, in patients with colorectal cancer requiring two-stage surgery for the resection of hepatic metastases, the efficiency of a resorbable barrier membrane (Seprafilm) for limiting abdominal and peri-hepatic adhesion during the second operation.
This study is a prospective multicentric phase II, controlled, randomized and non comparative trial.
A total of 60 patients will be enrolled: 45 will receive Seprafilm whereas 15 will be assigned to the no-treatment control group. The inclusion period should be approximately 18 months. The follow up period after the second surgery will be 3 years.
详细描述
The secondary objectives of the study are:
During and after the 1st surgical procedure To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (between 1st and 2nd surgeries) in relation with operating procedure and use of resorbable membrane.
During and after the 2nd surgical procedure
- To evaluate abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description.
- To evaluate intestinal adhesion (in the small intestine), with quantitative description.
- To evaluate immediate complications (during surgery), early complications (during post-surgery hospitalization) and late complications (in the month following the intervention) in relation with operating procedure.
- To evaluate post-operative rehabilitation
- To assess tumour evolution in patients over a period of 3 years after the 2nd surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Women and men aged ≥ 18 years
- •Colorectal cancer with synchronous or metachronous hepatic metastases
- •Patients requiring two-stage surgery with laparotomy for the resection of hepatic metastases
- •The 2 operations should be scheduled in the same centre
- •The 2 operations should be scheduled at an interval of 1 to 6 months
- •Patient affiliated with social security
- •Patient able to read and write French
- •Written, voluntary, informed consent
排除标准
- •Patient with previous hepatic or biliary surgery through supra-umbilical incision (except biliary surgery with laparotomy more than 6 months previously)
- •Patient with previous major surgery except colorectal surgery for resection of primitive tumour
- •Metastasis removable in one surgical procedure
- •Non resectable metastasis
- •Follow-up impossible for social, geographical, familial or psychological reasons
- •Patient deprived of freedom
- •Patient enrolled in another experimental surgery trial
- •Pregnant or lactating woman
结局指标
主要结局
abdominal and peri-hepatic adhesion during the second operation
时间窗: Time to liberate liver (t0: incision and t1: liberation)
次要结局
- immediate complications during the first surgical procedure in relation with operating procedure and use of resorbable membrane(during the surgery)
- early complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane(during post-surgery hospitalization)
- late complications (after the 1st surgical procedure)in relation with operating procedure and use of resorbable membrane(between 1st and 2nd surgeries (2 operations should be scheduled at an interval of 1 to 6 months))
- abdominal and peri-hepatic adhesion (at the site of the 1st surgery), with qualitative and quantitative description(at the beginning of the 2nd surgical procedure)
- intestinal adhesion (in the small intestine), with quantitative description(at the beginning of the second surgical procedure)
- immediate complications in relation with operating procedure.(during the 2nd surgical procedure)
- early complications (after 2ng operation) in relation with operating procedure.(during post-surgery hospitalization)
- late complications in relation with operating procedure.(in the month following the 2nd intervention)
- post-operative rehabilitation(during post-surgery hospitalization)
- tumour evolution in patients(over a period of 3 years after the 2nd surgery)