NCT00641342终止2 期
Prevention of Parastomal Hernia by Primary Mesh Insertion: a Randomized Double-blinded Controlled Multi-centre Study.
University Hospital, Gentofte, Copenhagen4 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2007年3月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 198
- 试验地点
- 4
- 主要终点
- Parastomal hernia verified by CT-scan
研究概览
简要总结
Approximately 1/3 of patients with a permanent end-colostomy will experience a hernia around the stoma. In some cases these problems result in the need of surgical correction and the risk of recurrent hernia after operative intervention is regrettably high. Preliminary investigations suggest a role for primary mesh placement to prevent parastomal hernia. The use of a mesh as a preventive measure is a safe procedure. This study will focus on the effect of primary mesh placement (two different operative procedures are used) compared to patients without mesh placement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Permanent end-colostomy after surgery for rectosigmoid cancer with extirpation or Hartmann's procedure.
排除标准
- •Acute surgery
- •Known immune deficiency
- •Surgery with insertion of foreign body (orthopaedic prosthesis, mechanical or bio-logical heart valve etc.) within the last 3 months.
- •Pregnancy
- •Known inflammatory bowel disease
- •Lack of written informed consent
结局指标
主要结局
Parastomal hernia verified by CT-scan
时间窗: one year after surgery, reassessed after 2, 3 and 5 years
次要结局
- Clinically detected parastomal hernia(one year after surgery, reassessed after 2, 3 and 5 years)
- Pain(one year after surgery, reassessed after 2, 3 and 5 years)
- Disease specific and general health questionnaire(one year after surgery, reassessed after 2, 3 and 5 years)
研究者
Ismail Gögenur
Dr
University Hospital, Gentofte, Copenhagen
研究点 (4)
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