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CompletedNCT07433439meshprophUpdated Feb 25, 2026

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

An interventional study of mesh placement and conventional abdominal wall closure without mesh in Hernia Incisional and Incision Site Complication, sponsored by Juan Bellido-Luque.MD. Completed at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-25.

Sponsored by Juan Bellido-Luque.MD · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Jul 2020, registered Feb 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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?

02

Conditions studied

  • Hernia Incisional
  • Incision Site Complication

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03

In context

Incisional Hernia

219 studies on the registry are indexed under Incisional Hernia; 48 are open to participants now.

This study's enrollment of 110 is close to the median of 108 across 137 interventional studies indexed under Incisional Hernia.

Browse Incisional Hernia studies →

Lead sponsor

This is the only study on the registry with Juan Bellido-Luque.MD as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
110 participants (actual)

Study arms

  • Experimental
    Mesh group

    group in which a mesh is placed

    Procedure: mesh placement

  • Active comparator
    non mesh group

    group in which a mesh is not placed

    Other: conventional abdominal wall closure without mesh

Interventions

  • Proceduremesh placement

    mesh is placed in retromuscular space when abdominal wall is closed

  • Otherconventional abdominal wall closure without mesh

    conventional AWC without mesh

06

What researchers measure

Primary outcomes

  1. image detected IH rate

    incisional hernia rate after 12 and 24 posoperative months

    Time frame: 12 and 24 months

Secondary outcomes

  1. incision types

    types of incisions used

    Time frame: day 1 (surgical procedure)

  2. postoperative complications

    complications after surgical procedure

    Time frame: 3-6-12-24 postoperative months

07

Study locations

1 site
  • Juan Bellido
    Seville, Spain
08

References and documents

Study documents

  • Study protocol · Feb 23, 2026
  • Informed consent form · Feb 23, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — study protocol

Supporting information: Study protocol, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 25, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07433439
Lead sponsor
Juan Bellido-Luque.MD
Collaborators
Hospital Universitario Virgen Macarena
Responsible party
Juan Bellido-Luque.MD (medical doctor, Hospital Quiron Sagrado Corazon) — Sponsor-investigator
First posted
Feb 25, 2026
Start date
Jul 1, 2020
Primary completion
Dec 31, 2024
Completion
Jan 1, 2025
Last update
Feb 25, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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