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

Primary Purpose

Incisional Hernia

Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Control
Experimental
Sponsored by
Hospital de Mataró
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Incisional Hernia focused on measuring Hernia, Cholecystectomy, Mesh fixation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Mataró

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Control

Experimental

Arm Description

Simple closure

Simple closure + mesh

Outcomes

Primary Outcome Measures

Umbilical trocar site hernia incidence
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)

Secondary Outcome Measures

Seroma incidence
A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)
Hematoma incidence
A localized collection of extravasated blood clotted under the tissue (clinical assessment)
Wound infection incidence
Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically
Pain presence
Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)
Hospital discharge
When patients leave the hospital after the intervention, measured by hours
Operative time
Intervention duration, measured by minutes
Return to regular activity
When patient return to job or regular activities after surgery, measured by days
Patient satisfaction
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)
Surgeon satisfaction
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)

Full Information

First Posted
March 23, 2018
Last Updated
March 22, 2022
Sponsor
Hospital de Mataró
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1. Study Identification

Unique Protocol Identification Number
NCT03495557
Brief Title
Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.
Acronym
PSHERNIA
Official Title
Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Mataró

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia
Keywords
Hernia, Cholecystectomy, Mesh fixation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Control will have simple closure while experimental group will have simple closure+mesh
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Simple closure
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Simple closure + mesh
Intervention Type
Procedure
Intervention Name(s)
Control
Intervention Description
Fascial closure with simple polydioxanone suture 2/0 stitches
Intervention Type
Device
Intervention Name(s)
Experimental
Intervention Description
Onlay polypropylene mesh placement (MN mesh)
Primary Outcome Measure Information:
Title
Umbilical trocar site hernia incidence
Description
Umbilical trocar site hernia incidence after 6 months and 1 year (clinical assessment) and after 3 years (radiological confirmation)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Seroma incidence
Description
A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment)
Time Frame
6 months
Title
Hematoma incidence
Description
A localized collection of extravasated blood clotted under the tissue (clinical assessment)
Time Frame
6 months
Title
Wound infection incidence
Description
Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically
Time Frame
6 months
Title
Pain presence
Description
Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain)
Time Frame
6 months, 1 and 3 years
Title
Hospital discharge
Description
When patients leave the hospital after the intervention, measured by hours
Time Frame
48 hours
Title
Operative time
Description
Intervention duration, measured by minutes
Time Frame
2 hours
Title
Return to regular activity
Description
When patient return to job or regular activities after surgery, measured by days
Time Frame
6 months
Title
Patient satisfaction
Description
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)
Time Frame
3 years
Title
Surgeon satisfaction
Description
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)
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Ciscar, MD
Organizational Affiliation
Hospital de Mataró
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Mataró
City
Mataró
State/Province
Barcelona
ZIP/Postal Code
08304
Country
Spain

12. IPD Sharing Statement

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

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