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

Study Overview
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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.

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

Conditions
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Incisional Hernia

Intervention / Treatment
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* Procedure: Control
* Device: Experimental


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Control will have simple closure while experimental group will have simple closure+mesh
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control<br>Simple closure | Procedure: Control<br>* Fascial closure with simple polydioxanone suture 2/0 stitches<br>|
| Experimental: Experimental<br>Simple closure + mesh | Device: Experimental<br>* Onlay polypropylene mesh placement (MN mesh)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Umbilical trocar site hernia incidence | 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 | A mass or tumefaction caused by the localized accumulation of serum within the tissue (clinical assessment) | 6 months | 
| Hematoma incidence | A localized collection of extravasated blood clotted under the tissue (clinical assessment) | 6 months | 
| Wound infection incidence | Combination of redness, swelling, warm and/or fluid drainage in the wound assessed clinically | 6 months | 
| Pain presence | Pain presence related to the umbilical wound scored from 0 (no pain) to 10 (severe pain) | 6 months, 1 and 3 years | 
| Hospital discharge | When patients leave the hospital after the intervention, measured by hours | 48 hours | 
| Operative time | Intervention duration, measured by minutes | 2 hours | 
| Return to regular activity | When patient return to job or regular activities after surgery, measured by days | 6 months | 
| 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) | 3 years | 
| 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) | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cholecystectomy, Hernia, Mesh fixation