Prophylactic Mesh Placement Reduces the Incidence of Incisional Hernia in HBP Surgery. (meshproph)

February 24, 2026 updated by: Juan Bellido-Luque.MD

he goal of this observational study is to learn about prophylactic mesh placement in HBP incision. The main question it aims to answer is:

will the incisional hernia rate be reduced with the use of mesh during the abdominal wall closuer?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

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
      • Seville, Spain
        • Juan Bellido

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients aged 18 years or older.
  • Elective conventional or extensive right subcostal laparotomy.
  • Two or more risk Factor for incisional hernia (IH): > 60 years, Body Mass Index > 27 kg/m2, Diabetes Mellitus, pulmonary/liver/renal disease, malignancy, preoperative chemotherapy, immunosuppression or smoking5.
  • Life expectancy of at least 12 months.
  • Signed informed consent with agreement to attend all study visits.

Exclusion Criteria:

  • Emergency surgery.
  • Previous right subcostal hernia or right subcostal incision.
  • Metastatic disease or irresectable malignancy identified during the surgery with life expectancy less than 12 months.
  • Active abdominal infection at the time of surgery

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

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesh group
group in which a mesh is placed
Procedure: mesh placement
mesh is placed in retromuscular space when abdominal wall is closed
Active Comparator: non mesh group
group in which a mesh is not placed
Other: conventional abdominal wall closure without mesh
conventional AWC without mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
image detected IH rate
Time Frame: 12 and 24 months
incisional hernia rate after 12 and 24 posoperative months
12 and 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incision types
Time Frame: day 1 (surgical procedure)
types of incisions used
day 1 (surgical procedure)
postoperative complications
Time Frame: 3-6-12-24 postoperative months
complications after surgical procedure
3-6-12-24 postoperative months

Collaborators and Investigators

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

Sponsor

Juan Bellido-Luque.MD

Collaborators

Hospital Universitario Virgen Macarena

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)

July 1, 2020

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 24, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

February 25, 2026

Last Update Submitted That Met QC Criteria

February 24, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Virgen Macarena Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

study protocol

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

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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