Prevention of Parastomal Hernias and Incisional Hernias in Old Stoma Wounds: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
研究概览
简要总结
Knowing that the risk of stoma associated herniation (parastomal or incisional) is 30-50% and the associated morbidity significant, standard placement of a prophylactic mesh upon stoma creation might prevent parastomal (or incisional herniation, after closure) and improve the quality of life of a large group of patients. This study is meant to be a pilot study to see whether the mesh related risks of infection and adhesion morbidity are acceptable if the mesh is placed intraperitoneally.
详细描述
The idea of a prophylactic mesh has been tested before in a Swedish randomized controlled trial (RCT) with the mesh placed upon end colostomy formation. Results suggest this procedure is the panacea against stoma associated herniations. The investigators still have unanswered questions however, about the size and ideal position of the mesh, possible complications (infection, adhesions) and the benefit in terms of quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Adult patients with a life expectancy of at least one year
- •Temporary stoma formation
- •Signed informed consent
- •Elective surgery
- •Clean-contaminated abdomen
排除标准
- •American Society of Anaesthesiologists (ASA) score IV or above
- •Incapacitated adult or no signed informed consent
- •Emergency procedure
- •Contaminated or infected abdomen
- •Residual intraperitoneal mesh
- •Already injured part of the abdominal wall where the stoma will be sited
- •Contraindication to laparoscopy
- •Longterm use of corticosteroids and other immunosuppressive agents
- •Current antibiotic therapy
- •One of the following conditions: immune deficiency, chemotherapy, ascites, peritoneal dialysis, pregnancy
结局指标
主要结局
postoperative complications after prophylactic mesh placement around a stoma (i.e., infection of the mesh and adhesions to the mesh)
时间窗: one year after placement
incisional herniation at the old stoma wound
时间窗: two years
次要结局
- stoma complications (stenosis, bulging, prolapse, retraction, skin problems)(two years after placement)
研究者
Marc Schreinemacher
investigator
Academisch Ziekenhuis Maastricht