Prophylactic Mesh Placement During Temporary Stoma Closure: a Prospective Randomized Phase III Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- hernia rate
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy of using polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer and non-mesh repair. The main question it aims to answer is: can mesh help prevent hernia? Participants will be divided into 2 groups: with and without mesh using. They must be followed up for 2 years after enrollment in the study.
Researchers will compare mesh and non-mesh groups to evaluate the benefits and harms of mesh using in hernia prevention.
详细描述
This clinical trial is prospective randomized phase III study of the efficacy of polypropylene mesh for hernia prevention after stoma closure in patients with colorectal cancer. We will include in the study group 71 patients with colorectal cancer with ileo- and colostomy. In these patients we will do sublay/interoblique repair in prevention incisional hernias using polypropylene mesh. Our hypothesis is to reduce parastomal hernias rate from 30% to 10% over 2 years. Stratification will be used for patients with >5 cm vs <5 cm stoma-site hernia.
The control group will include 71 patients with similar parameters who will undergo stoma closure with layered ligature suturing of the abdominal wall without mesh implantation.
Additional endpoints are the wound infection rate, the complication rate (Clavien-Dindo), the rate of the repeated surgery for hernia at the site of stoma closure. We'll assess the quality of life by HerQLes (Hernia-Related Quality of Life Survey) scale.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Absence of distant metastases (M0)
- •ECOG (Eastern Cooperative Oncology Group) status 0-2
- •completed course of adjuvant treatment
- •Absence of acute inflammatory parastomal complications
- •Integrity of colorectal anastomosis
排除标准
- •Inability to obtain consent to participate
- •Synchronous and metachronous malignant neoplasms
- •Clinically significant diseases of the cardiovascular system, liver, kidney, central nervous system
- •Parastomal inflammation and other conditions that increase the risk of postoperative complications
- •Pregnancy
- •HIV infection
结局指标
主要结局
hernia rate
时间窗: 2 years
The rate of parastomal hernias after stoma closure for 2 years.
次要结局
- 90 day surgical morbidity(90 days)
- Quality of life indicators by HerQLes scale(2 years)
研究者
Sergey Gordeyev
Principal investigator, Department of Colorectal surgery
Blokhin's Russian Cancer Research Center