Barbed Suture for Emergency Midline Laparotomy Closure

Completed

• Conditions: Incisional Hernia of Midline of Abdomen
• Interventions: Procedure: Barbed

• Registration Number: NCT05351970
• Lead Sponsor: Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-23
• Study First Posted: 2022-04-28
• Primary Completion: 2022-12-31
• Study Completion: 2023-06-15
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-21
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Barbed closure	Barbed	Patients with midline emergency laparotomy, which closure was performed with barbed suture

Primary Outcome Measures

Name	Time	Method
Incisional Hernia 1 year	Hernia 1 year	Incidence of incisional hernia at one year after surgery
Incisional Hernia 1 month	Hernia 1 month	Incidence of incisional hernia at one month after surgery

Secondary Outcome Measures

Name	Time	Method
Evisceration	1 month	Incidence of early abdominal evisceration
Surgical Site Infection	1 month	Incidence of postoperative surgical site infection
Medical complications	1 month	Incidence of other medical complications

Trial Locations

Locations (1)

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain