- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495557
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
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PORT SITE HERNIA
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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