Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.

October 6, 2020 updated by: José A. Pereira
Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.

Study Type

Observational

Enrollment (Actual)

187

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

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients who underwent emergency midline laparotomies in the period between January 2009 and July 2010 in our University Hospital. We included all consecutive patients. with at least 2 years of follow-up.

Description

Inclusion Criteria:

  • Patients undergoing emergency midline laparotomy

Exclusion Criteria:

  • Those with need of concomitant hernia repair.
  • Those who received incisions outside the midline.
  • Those with delayed abdominal closure.
  • Those who died in the immediate postoperative period.
  • Those without a minimum 2 years of follow-up.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prophylactic mesh
Patients who received a prophylactic mesh after emergency surgery due to high risk of incisional hernia.
Procedure: Prophylactic mesh use
After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.
Other Names:
  • Incisional hernia prevention
Suture
Patients who's laparotomies closure was using only suture without any abdominal wall reinforcement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incisional hernia
Time Frame: 2 years
Detection of clinical or subclinical incisional hernia during postoperative longterm followup
2 years

Collaborators and Investigators

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

Sponsor

José A. Pereira

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

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, 2010

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2020

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 6, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20198240I

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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