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

Hospital de Mataró

Status and phase: Completed; Phase 4

Conditions: Incisional Hernia

Treatments: Device: Experimental; Procedure: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT03495557

PORT SITE HERNIA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Control

Sham Comparator group

Description:

Simple closure

Treatment:

Procedure: Control

Experimental

Experimental group

Description:

Simple closure + mesh

Treatment:

Device: Experimental