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临床试验/CTRI/2025/06/088133
CTRI/2025/06/088133尚未招募2 期

Comparison of early outcomes of interrupted double X suture versus continuous far near-near far method for closure of abdominal wall incisions: A double blinded randomised control trial

All India Institute of Medical SciencesNew Delhi1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2025年6月23日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
220
试验地点
1
主要终点
To compare the incidence of burst abdomen following interrupted double ‘X’ suture vs Smead Jones far near - near far continuous method

研究概览

简要总结

Double X interrupted suture technique of abdominal wall closure will result in significant reduction in the incidence of  burst abdomen, surgical site infection and incisional hernia as compared to continuous closure technique for abdominal wall incisions more than five centimeters (cm) in length.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • •Age > 18 years Midline/ non midline incisions ( midline, paramedian, right subcostal, lumbar, pfannensteil ) > five cms in length Elective / Emergency procedures.

排除标准

  • •Age < 18 years Patients undergoing re-laparotomy Patients who underwent previous hernia repair Patients with incisional hernia Patients with documented collagen vascular diseases Patients undergoing emergency laparotomy where fascial closure is not possible and requires a mesh laparostomy Pregnancy Patients unfit for general anaesthseia Refusal for consent.

结局指标

主要结局

To compare the incidence of burst abdomen following interrupted double ‘X’ suture vs Smead Jones far near - near far continuous method

时间窗: At time of surgery | 1 week | 1 month | 3 month | 6 month

To compare surgical site infection following interrupted double ‘X’ suture vs Smead Jones far near - near far continuous method

时间窗: At time of surgery | 1 week | 1 month | 3 month | 6 month

次要结局

  • To compare the incidence of incisional hernia at the end of six months follow up between interrupted double ‘X’ suture vs Smead Jones far near - near far continuous method(To compare postoperative wound pain between interrupted double ‘X’ suture and Smead Jones far near - near far continuous method at 1 week, 1 month and 3 months using Visual Analog Scoring system of pain)

研究者

发起方
All India Institute of Medical SciencesNew Delhi
申办方类型
Research institution and hospital

研究点 (1)

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