Trials / Completed
CompletedNCT03495557
Prevalence of Port Site Hernia After Mesh Placement in Laparoscopic Cholecystectomy.
Evaluation of Port Site Hernia Prevalence After Prophylactic Mesh Placement Following Laparoscopic Cholecystectomy: Randomized Clinical Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (actual)
- Sponsor
- Hospital de Mataró · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Control | Fascial closure with simple polydioxanone suture 2/0 stitches |
| DEVICE | Experimental | Onlay polypropylene mesh placement (MN mesh) |
Timeline
- Start date
- 2018-01-01
- Primary completion
- 2020-12-01
- Completion
- 2021-09-01
- First posted
- 2018-04-12
- Last updated
- 2022-03-23
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03495557. Inclusion in this directory is not an endorsement.