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

March 22, 2022 updated by: Ana Ciscar, Hospital de Mataró

Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

200

Phase

  • Phase 4

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

    • Barcelona
      • Mataró, Barcelona, Spain, 08304
        • Hospital de Mataro

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
SHAM_COMPARATOR: Control
Simple closure
Fascial closure with simple polydioxanone suture 2/0 stitches
EXPERIMENTAL: Experimental
Simple closure + mesh
Onlay polypropylene mesh placement (MN mesh)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Umbilical trocar site hernia incidence
Time Frame: 3 years
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seroma incidence
Time Frame: 6 months
A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)
6 months
Hematoma incidence
Time Frame: 6 months
A localized collection of extravasated blood clotted under the tissue (clinical assessment)
6 months
Wound infection incidence
Time Frame: 6 months
Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically
6 months
Pain presence
Time Frame: 6 months, 1 and 3 years
Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)
6 months, 1 and 3 years
Hospital discharge
Time Frame: 48 hours
When patients leave the hospital after the intervention, measured by hours
48 hours
Operative time
Time Frame: 2 hours
Intervention duration, measured by minutes
2 hours
Return to regular activity
Time Frame: 6 months
When patient return to job or regular activities after surgery, measured by days
6 months
Patient satisfaction
Time Frame: 3 years
How satisfied/unsatisfied is the patient with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)
3 years
Surgeon satisfaction
Time Frame: 3 years
How satisfied/unsatisfied is the surgeon with the whole process measured by a survey form which classify it in a range from 0 (very unsatisfied) to 5 (very satisfied)
3 years

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Ana Ciscar, MD, Hospital de Mataro

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)

January 1, 2018

Primary Completion (ACTUAL)

December 1, 2020

Study Completion (ACTUAL)

September 1, 2021

Study Registration Dates

First Submitted

March 23, 2018

First Submitted That Met QC Criteria

April 4, 2018

First Posted (ACTUAL)

April 12, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 23, 2022

Last Update Submitted That Met QC Criteria

March 22, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

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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