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OpenTrials
Completed

NCT Number: NCT05351970

Barbed Suture for Emergency Midline Laparotomy Closure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital General Universitario de Elche

Elche, Alicante, 03203, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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...).

Treatment and study plan

Barbed

Procedure

Efficacy of barbed and monofilament closure regarding incisional hernia

Primary outcomes

  1. Incisional Hernia 1 month

    Time frame: Hernia 1 month

    Incidence of incisional hernia at one month after surgery

  2. Incisional Hernia 1 year

    Time frame: Hernia 1 year

    Incidence of incisional hernia at one year after surgery

Secondary outcomes

  1. Surgical Site Infection

    Time frame: 1 month

    Incidence of postoperative surgical site infection

  2. Evisceration

    Time frame: 1 month

    Incidence of early abdominal evisceration

  3. Medical complications

    Time frame: 1 month

    Incidence of other medical complications

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: BAROTOMY

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 28, 2022
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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