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

NCT07433439 | Completed DMC

• 1 other identifier: Virgen Macarena Hospital
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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?

Conditions

Hernia Incisional; Incision Site Complication

Outcome Measures

Primary Outcomes (1)

• image detected IH rate

  incisional hernia rate after 12 and 24 posoperative months

  12 and 24 months

Secondary Outcomes (2)

• incision types

  day 1 (surgical procedure)

• postoperative complications

  3-6-12-24 postoperative months

Study Arms (2)

Mesh group

EXPERIMENTAL

group in which a mesh is placed

Procedure: mesh placement

non mesh group

ACTIVE COMPARATOR

group in which a mesh is not placed

Other: conventional abdominal wall closure without mesh

Interventions

mesh placement PROCEDURE

mesh is placed in retromuscular space when abdominal wall is closed

Mesh group

conventional abdominal wall closure without mesh OTHER

conventional AWC without mesh

non mesh group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juan Bellido-Luque.MD: lead
• Hospital Universitario Virgen Macarena: collaborator

Study Sites (1)

Juan Bellido

Seville, Spain

Location

MeSH Terms

Conditions

Incisional Hernia

Interventions

Melanocyte-Stimulating Hormones

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: medical doctor

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 25, 2026
• Study Start: July 1, 2020
• Primary Completion: December 31, 2024
• Study Completion: January 1, 2025
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

ES (1)