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

Phase 4

Completed

• Conditions: Incisional Hernia

• Registration Number: NCT03495557
• Lead Sponsor: Hospital de Mataró

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2018-03-23
• Study First Submitted QC: 2018-04-04
• Study First Posted: 2018-04-12
• Primary Completion: 2020-12-01
• Study Completion: 2021-09-01
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-22
• Last Update Posted: 2022-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hospital de Mataró; 🇪🇸 Mataró, Barcelona, Spain