ACTRN12611001252909终止未知
A randomised, controlled multicentre trial to assess the safety and efficacy of prophylactic mesh in the prevention of parastomal herniae.
The Lyell McEwin Hospital0 个研究点目标入组 80 人开始时间: 2011年12月6日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 85 Years（—）
- 性别
- All
入选标准
- •Subjects requiring elective admission for an open colon or colorectal resection to include the formation of a permanent end colostomy. The procedures will include the following:
- •a. Abdomino-perineal resection of the rectum;
- •b. Rectosigmoidectomy (Hartmann’s procedure); or
- •c. Formation of end colostomy for incontinence.
排除标准
- •1. Subjects who do not consent to participate in the trial or are unable to provide informed consent. This may include patients who are not able to understand or follow the trial protocol because English is not their first language, or because of medical or psychiatric conditions.
- •2. Subjects who are having emergency operations.
- •3. Subjects with grossly disseminated disease, who are not expected to live longer than 12 months.
- •4. Subjects in whom there is significant spillage of faecal contents in the area of the wound or the stoma site during the procedure.
- •5. Subjects with inflammatory bowel disease, including Crohn's disease or irritable bowel syndrome.
- •6. Subjects with concurrent infection at the operating site or the stoma site at the time of the surgery.
- •7. Females who are pregnant or breastfeeding.
研究者
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