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Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03495557
Study type Interventional
Source Hospital de Mataró
Contact Ana Ciscar, MD
Phone 0034639293172
Status Recruiting
Phase Phase 4
Start date January 1, 2018
Completion date January 1, 2022

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