Chimney Trial - Randomized, Controlled, Multi Center Trial of Parastomal Hernia Prevention
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 141
- 试验地点
- 7
- 主要终点
- Incidence of parastomal hernia
研究概览
简要总结
Chimney trial is designed to compare the effectiveness and safety of specifically designated polyvinylidene fluoride mesh (PVDF, Dynamesh IPST) to controls in a multi center, randomized setting.
详细描述
The European Hernia Society recommends the use of prophylactic mesh when permanent colostomy is made. The results of previous trials using keyhole technique are partially unsatisfactory. Specifically designed PVDF mesh used in this trial showed promising results in previous small trial.
Chimney trial is designed to compare the effectiveness and safety of mesh group to controls operated with no preventive mesh in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection or low Haartman's procedure for rectal adenocarcinoma.
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
- Single (Participant)
盲法说明
Participants are unaware of the randomization group.
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
- •18 years or older
- •Rectal adenocarcinoma with curative intent laparoscopic or robotic assisted abdominoperineal resection or low Hartmann´s operation and permanent colostomy
- •Patient has a life expectancy of at least 12 months.
- •Patient must sign Informed consent before any study procedures and agrees to attend all study visits
排除标准
- •Abdominoperineal resection or Hartmann's operation by laparotomy or conversion to laparotomy
- •Complication requiring laparotomy during post surgery treatment at surgical ward after APR
- •Patient with a comorbid illness or condition that would preclude the use of surgery (ASA 4-5).
- •Patients with concurrent or previous malignant tumors within 5 years before study enrollment
- •Patients with T4b tumors which impose a multi-organ resection
- •Rectal malignancy other than adenocarcinoma
- •Patient undergoing emergency procedures
- •Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- •Metastatic disease with no possibility of curative surgery
- •Pregnant or suspected pregnancy
- •Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
- •Active abdominal infection at the time of surgery
- •Previous surgery at the colostomy site
- •Language barrier or other reasons why informed consent is not possible
结局指标
主要结局
Incidence of parastomal hernia
时间窗: 12 months
Incidence of parastomal hernia at 12 months follow up
次要结局
- Complications(30 days)
- Operative time(1 day)
- Incidence of parastomal hernia at long term follow up(5 years)
- Stoma related complications(5 years)
- Radiological substudy of adipose tissue thickness(3 years)
- Surgical site infection rate(30 days)
- Reoperation rate(5 years)
- Length of stay(30 days)
- Quality of life measured by Colostomy impact score(5 years)
- Medico-economic substudy(5 years)
- Radiological substudy of stoma distance(3 years)
- Rand 36 quality of life(5 years)
研究者
Elisa Mäkäräinen
Principal Investigator
University of Oulu