APEMESH- Preventing Perineal Complications After Abdominoperineal Resection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Comprehensive Complication index
研究概览
简要总结
Abdominoperineal resection leaves an empty space to be filled by mesh or musculocutaneus flap. Several studies have reported over 30% morbidity with perineal wound healing after abdominoperineal resection. Preoperative radiotherapy is a strong predictor for perineal complications. Musculocutaneus flaps and use of biological mesh seem to minimize perineal morbidity. The role of omentoplasty at APR is controversial.
Previous studies on synthetic mesh repair on perineum are almost lacking.
详细描述
The objective of this pilot study is to assess the feasibility and the potential benefits of synthetic mesh reconstruction in perineum in case-control setting.
30 subjects will be prospectively enrolled to this study as intervention group. Controls matched with age, gender and preoperative radiotherapy are selected from retrospective data collected from Oulu University database and operated for rectal adenocarcinoma 2009-2017 with otherwise identical methods.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 and permanent colostoma
排除标准
- •Patient with a comorbid illness of condition that would preclude the use of surgery (ASA5)
- •Potentially curable resection not possible
- •Patient undergoing emergency procedure
- •Metastatic disease
- •Pregnant or suspected pregnancy
结局指标
主要结局
Comprehensive Complication index
时间窗: 30 days
Comprehensive Complication index is used to evaluate outcome
次要结局
- Length of stay(30 days)
- Costs(30 days)
- Perineal sinus(30 days)
- Perineal hernia(12 months)
- Operative time(30 days)
- Surgical site infection(30 days)
- Reoperation rate(30 days)
- Total perineal healing time(30 days)
研究者
Elisa Mäkäräinen
Principal Investigator
University of Oulu