PRESTOMA- A Prospective Randomized Controlled Multicenter Trial Comparing Three Meshes for Prevention of Parastomal Hernia After Abdominoperineal Resection for Rectal Adenocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 6
- 主要终点
- Incidence of parastomal hernia
研究概览
简要总结
Prestoma Trial is designed to compare the safety and efficiency of three different meshes and techniques to prevent parastomal hernia after laparoscopic or robotic-assisted abdominoperineal resection for rectal adenocarcinoma.
详细描述
Parastomal hernia after permanent colostomy formation is a common problem. The European Hernia Society recommends the use of prophylactic mesh when the stoma is constructed. So far, there're no trials comparing the methods to prevent the parastomal hernia.
Prestoma Trial is designed to compare the most researched retromuscular mesh (Parietene Macro by Medtronic) with two different types of intraperitoneal meshes (Parietex Parastomal by Medtronic and Dynamesh IPST) in parastomal hernia prevention after laparoscopic or robotic-assisted abdominoperineal resection 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
Subject is blinded of the mesh used. Outcome at 12 month follow-up is assessed by surgeon who was not involved in the operation.
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
- •Abdominoperineal resection for rectal cancer with permanent end colostomy, either by laparoscopic technique or robotic assistance
- •18 years or older
- •Patient has a life expectancy of at least 12 months.
- •Patient signs the Informed consent and agrees to attend all study visits.
排除标准
- •Abdominoperineal resection by laparotomy or conversion to laparotomy
- •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
- •Potentially curable resection not possible
- •Patient undergoing emergency procedures
- •Planned rectal surgery along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
- •Metastatic disease with life expectancy of less than 1 year
- •Pregnant or suspected pregnancy
- •Patients living geographically distant and/or unwilling to return for follow-ups or comply with all study requirements
研究组 & 干预措施
Parietene Macro
Parietene Macro is a macroporous synthetic mesh.
干预措施: Parietene Macro (Device)
Parietex Parastomal
Parietex Parastomal is a synthetic mesh with resorbable collagen lining to prevent attachments.
干预措施: Parietex Parastomal (Device)
Dynamesh IPST
Dynamesh IPST is synthetic mesh with central tube to accommodate bowel tightly designed to prevent and treat parastomal hernia.
干预措施: Dynamesh IPST (Device)
结局指标
主要结局
Incidence of parastomal hernia
时间窗: 1 year
The primary outcome is incidence of parastomal hernia at 12 months follow up, detected clinically or on CT scan.
次要结局
- Complications(30 days)
- Surgical infections(30 days)
- Stoma related complications(5 years)
- Reoperation rate(5 years)
- Quality of Life measured by RAND 36(5 years)
- Operative time(30 days)
- Length of stay(30 days)
研究者
Elisa Makarainen-Uhlback
M.D.
University of Oulu