Barbed Suture for Emergency Midline Laparotomy Closure (BAROTOMY)

April 21, 2024 updated by: Luis Sánchez Guillen, Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

128

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with emergency laparotomy performed due to digestive surgical disease.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Monofilament closure
Patients with midline emergency laparotomy, which closure was performed with monofilament suture
Barbed closure
Patients with midline emergency laparotomy, which closure was performed with barbed suture
Procedure: Barbed
Efficacy of barbed and monofilament closure regarding incisional hernia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incisional Hernia 1 month
Time Frame: Hernia 1 month
Incidence of incisional hernia at one month after surgery
Hernia 1 month
Incisional Hernia 1 year
Time Frame: Hernia 1 year
Incidence of incisional hernia at one year after surgery
Hernia 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infection
Time Frame: 1 month
Incidence of postoperative surgical site infection
1 month
Evisceration
Time Frame: 1 month
Incidence of early abdominal evisceration
1 month
Medical complications
Time Frame: 1 month
Incidence of other medical complications
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

December 31, 2022

Study Completion (Actual)

June 15, 2023

Study Registration Dates

First Submitted

April 18, 2022

First Submitted That Met QC Criteria

April 23, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 21, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAROTOMY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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