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临床试验/NCT05351970
NCT05351970已完成不适用

Barbed Suture vs. Monofilament for Emergency Midline Laparotomy Closure, a Retrospective Analysis

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
128
试验地点
1
主要终点
Incisional Hernia 1 year

研究概览

简要总结

Urgency surgeries are often performed in a stressful setting with critical patient involved. In this context, laparotomy closure can sometimes be the most neglected part of the procedure. Barbed sutures, frequently used in laparoscopic procedures, have proven to be effective in maintaining traction.

The aim of this study is to describe the incisional hernia rate after emergency midline laparotomy, according to the suture utilized, evaluated at one month and one year postoperative.

详细描述

A retrospective cohort study was performed including patients with urgency midline laparotomy during 2018-2019. Group A was represented by patients with slowly absorbable monofilament continuous suture, while Group B included patients with barbed suture closure.

Main variables were hernia rates one month and one year after surgery, diagnosed by physical exploration and/or imaging. Demographic characteristics, risk factors, among other descriptive determinations were registered.

A total of 128 patients were performed an emergency midline laparotomies, and 110 meet all inclusion criteria. There was equality between sex and median age was 65 years old. Significative differences were observed regarding incisional hernia at 30 days, being less frequent when barbed suture was utilized. These differences were not present at the long-term reevaluation (one year).

In conclusion, midline laparotomy closure must be performed within quality standards. The lack of studies regarding emergency laparotomy closure, the European Hernia Society stated that no recommendations can be given on this patients. Barbed suture appears as a promising option for closure in these specific circumstances, but needs further study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Emergency laparotomy
  • Minimum age of 18 years old.
  • Digestive surgical disease.
  • Minimum survival of one month postoperatively.

排除标准

  • Laparoscopic surgical procedure.
  • Non-digestive surgical procedure (gynecology, urology...).

结局指标

主要结局

Incisional Hernia 1 year

时间窗: Hernia 1 year

Incidence of incisional hernia at one year after surgery

Incisional Hernia 1 month

时间窗: Hernia 1 month

Incidence of incisional hernia at one month after surgery

次要结局

  • Medical complications(1 month)
  • Evisceration(1 month)
  • Surgical Site Infection(1 month)

研究者

发起方
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luis Sánchez Guillen

Clinical Professor Luis Sánchez-Guillén

Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

研究点 (1)

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