跳至主要内容
临床试验/CTRI/2024/03/064359
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

发起方
Dr Babasaheb Ambedkar Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Akshant

Dr Babasaheb Ambedkar Hospital

研究点 (1)

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