Reducing the Incidence of Incisional Hernia After Stoma Closure Using a PROphylactic MESH: a Single-blinded Randomized Controlled Trial (PROMESH TRIAL).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Incidence of incisional hernia at site of stoma at one year after closure
研究概览
简要总结
Background:
Preliminary studies have shown that application of a prophylactic mesh during stoma closure reduces the incidence of incisional hernia at site of stoma closure.
Methods/Design:
The study will be a randomized controlled single-blinded monocentric study determining the 1-year incidence of incisional hernia in cancer patients undergoing ileostomy or colostomy closure with or without prophylactic non-absorbable mesh applied in the sublay position.
Discussion:
Prevention of incisional hernia at site of stoma closure will lead to an improvement in patients' quality of life and generating savings for healthcare systems. To date, no randomized controlled trial assessing the effect of prophylactic mesh applied during stoma closure on the prevention of incisional hernia has been published. With the present randomized controlled trial, we expect to demonstrate that the application of a prophylactic mesh reduces the one-year incidence of incisional hernia at site of stoma closure.
详细描述
Background:
Recent pooled evidence indicates that the incidence of incisional hernia after stoma closure is of 7.4%, but this finding is limited by an important heterogeneity (reported incidences ranging from 0 to 48%). The pooled incidence of incisional hernia ranges from 4 to 10% according to the type of stoma, with the highest incidence reported after colostomy closure (10%). These incisional hernias at site of stoma generate patient discomfort, alteration of quality of life, complications such as bowel occlusion and increased costs for healthcare systems.
Several retrospective studies have investigated the impact of a prophylactic mesh during stoma closure on the incidence of incisional hernia. For instance, Liu et al. compared 47 patients who benefited from ileostomy closure with a synthetic non-resorbable mesh with 36 patients who underwent the same surgery without mesh, and found that incidences of incisional hernia (with a median follow-up of 18 months) were of 6.4% and 36.1%, respectively 3. Similarly, a retrospective case-control study compared 30 patients who had ileostomy closure with prophylactic biological mesh with 30 matched patients without mesh. At one year, the incidence of incisional hernia diagnosed with CTscan was of 3.3% in patients with mesh versus 40% in patients without mesh 4. A multicenter randomized controlled trial (RCT) is currently underway to evaluate whether an intra-abdominal mesh allows to prevent the one year incidence of CTscan-proven incisional hernia in patients undergoing ileostomy and colostomy closures 5. A preliminary feasibility study demonstrated the safety of the procedure 6. However, no specific techniques for mesh fixation and position are documented in the RCT protocol, which might introduce confusion factors in the final analysis. Further, applying an intra-abdominal mesh might potentially result in long-term complications due to bowel adhesion to the abdominal wall.
Therefore, we have planned to undertake a RCT aiming at determining whether a prophylactic non-resorbable mesh in the sublay position allows or not reducing the incidence of incisional hernia after ileostomy or colostomy closure.
Methods/Design:
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
Patients will be blinded for the study 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
- 是
入选标准
- •Adult patient
- •Ileostomy or colostomy performed during surgery for digestive cancer
- •Planned elective closure of ileostomy or colostomy
- •Informed written consent
排除标准
- •Allergy to the mesh
- •Patients under corticosteroids or other immunosuppressive treatment
- •Inability/refusal to follow the procedures of the study
结局指标
主要结局
Incidence of incisional hernia at site of stoma at one year after closure
时间窗: At one year after stoma closure
The presence or not of an incisional hernia will be assessed clinically by a specialist in general surgery and radiologically by computed tomography realized in the setting of cancer followup. The investigator performing the 1-year follow-up and the radiologist interpreting the CTscan will be blinded for the study group. Patients diagnosed with incisional hernia and/or reoperated for a complication related to stoma closure and/or mesh will be considered as treatment failure.
次要结局
- Incidence of surgical site infection (SSI) at site of stoma closure(At seven days and 31 days after stoma closure)
研究者
Jeremy Meyer
Consultant surgeon
University Hospital, Geneva