Prophylactic Mesh Placement Reduces the Incidence of Inci... | NCT07433439

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

NCT07433439

Sponsor

Juan Bellido-Luque.MD

Status

Completed

Last Update Posted

Feb 25, 2026Actual

Enrollment

110Actual

Phase

Not Applicable

Conditions

Hernia Incisional
Incision Site Complication

Interventions

mesh placement
conventional abdominal wall closure without mesh

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Dec 31, 2024Actual

Completion Date

Jan 1, 2025Actual

First Submitted Date

Feb 9, 2026

First Submission Date that Met QC Criteria

Feb 24, 2026

First Posted Date

Feb 25, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 24, 2026

Last Update Posted Date

Feb 25, 2026Actual

Name	Class
Hospital Universitario Virgen Macarena	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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?

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
mesh placement	Procedure	mesh is placed in retromuscular space when abdominal wall is closed	Mesh group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
incision types	types of incisions used	day 1 (surgical procedure)
postoperative complications	complications after surgical procedure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

study protocol

Types

Study Protocol
Informed Consent Form (ICF)

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol: cicat protocol	Feb 23, 2026	Feb 24, 2026	Prot_000.pdf
ICF	No	No	Yes	Informed Consent Form: informed consen	Feb 23, 2026	Feb 24, 2026	ICF_001.pdf

Condition Browse Module

MeSH Terms

ID	Term
D000069290	Incisional Hernia

Ancestor Terms

ID	Term
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009074	Melanocyte-Stimulating Hormones

Ancestor Terms

ID	Term
D053486	Melanocortins
D011333	Pro-Opiomelanocortin
D007028	Hypothalamic Hormones
D036361	Peptide Hormones

Browse Leaves

Not provided

Browse Branches

Not provided