CTRI/2024/03/064359尚未招募2/3 期
Abdominal Closure after Emergency Laparotomy (ACE) trial: Comparison of Mass closure and Small bites techniques for closure after emergency laparotomy
Dr Babasaheb Ambedkar Hospital1 个研究点 分布在 1 个国家目标入组 296 人开始时间: 2024年4月1日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 296
- 试验地点
- 1
- 主要终点
- Incidence of Incisional Hernia postoperatively
研究概览
简要总结
Randomised, double blinded trial comparing small bites closure to mass closure with regards to their effect on rates of incisional hernia after emergency laparotomy. Mass closure is the current standard of care, however, small bites closure has been shown to reduce incidence of incisional hernia in elective surgery. Calculated sample size is 148 patients per arm. Primary outcome measure is incidence of incisional hernia post procedure. Secondary outcome measure is incidence of burst abdomen post procedure. Total duration of followup is 2 years from index procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •All patients undergoing emergency laparotomy with a midline abdominal incision.
排除标准
- •Pregnant women
- •Patients with non midline incision used to open the abdomen
- •Patients undergoing damage control laparotomy.
结局指标
主要结局
Incidence of Incisional Hernia postoperatively
时间窗: 3 months, 6 months, 12 months, 24 months
次要结局
- Burst abdomen(3 days, 7 days, 14 days, 28 days post operatively)
研究者
Akshant
Dr Babasaheb Ambedkar Hospital
研究点 (1)
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