Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.

NCT ID: NCT03495557

Last Updated: 2022-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-01

Study Completion Date

2021-09-01

Brief Summary

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A prophylactic mesh fixation after fascial closure in umbilical trocar after cholecystectomy may prevent the trocar site hernia incidence. Especially in patients who present certain risk factors.

Detailed Description

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Randomized controlled trial. Patients with more than two incisional hernia risk factors (age ≥70, BMI ≥30, diabetes mellitus, fascial enlargement) who undergo elective/emergent cholecystectomy. Control arm: fascial closure with simple PDS 2/0 Stitches. Study arm: fascial closure with simple PDS 2/0 stitches and onlay polypropylene mesh placement. Main outcome umbilical trocar site hernia incidence during a 3 years follow up. Clinical and radiological assessment.

Conditions

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Incisional Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Control will have simple closure while experimental group will have simple closure+mesh
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control

Simple closure

Group Type SHAM_COMPARATOR

Control

Intervention Type PROCEDURE

Fascial closure with simple polydioxanone suture 2/0 stitches

Experimental

Simple closure + mesh

Group Type EXPERIMENTAL

Experimental

Intervention Type DEVICE

Onlay polypropylene mesh placement (MN mesh)

Interventions

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Control

Fascial closure with simple polydioxanone suture 2/0 stitches

Intervention Type PROCEDURE

Experimental

Onlay polypropylene mesh placement (MN mesh)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years
* Laparoscopic cholecystectomy
* Emergent/elective
* ≥2 risk factors: diabetes mellitus, age ≥70 years, BMI ≥30, fascial enlargement

Exclusion Criteria

* Conversion to laparotomy
* Emergent re intervention
* Immunosuppression
* Umbilical hernia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Mataró

OTHER

Sponsor Role lead

Responsible Party

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Ana Ciscar

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ana Ciscar, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mataró

Locations

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Hospital de Mataró

Mataró, Barcelona, Spain

Site Status

Countries

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Spain

References

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Ciscar A, Sanchez-Saez E, Vila Tura M, Ruiz de Leon P, Gomez Pallares M, Troyano Escribano D, Abadal Prades M, Mans Muntwyler E, Pereira JA, Badia JM. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial. Hernia. 2024 Dec;28(6):2187-2194. doi: 10.1007/s10029-024-03124-7. Epub 2024 Aug 29.

Reference Type DERIVED
PMID: 39207550 (View on PubMed)

Other Identifiers

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PORT SITE HERNIA

Identifier Type: -

Identifier Source: org_study_id

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