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NCT03495557: PSHERNIA

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

Completed Phase 4 Last updated 23 March 2022
What this trial tests

Phase 4 trial testing Control in Incisional Hernia in 200 participants. Completed in 1 September 2021.

Timeline
1 January 2018
Primary endpoint
1 December 2020
1 September 2021

Quick facts

Lead sponsorHospital de Mataró
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeprevention
Enrollment200
Start date1 January 2018
Primary completion1 December 2020
Estimated completion1 September 2021
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Hospital de Mataró

Who can join

18 and older, any sex, with Incisional Hernia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Assessment of the effectiveness of a polypropylene onlay mesh in the prevention of laparoscopic trocar-site incisional hernia in high-risk patients. A randomized clinical trial.
    Ciscar A, Sánchez-Sáez E, Vila Tura M, Ruiz de Leon P, et al · · 2024 · cited 2× · PMID 39207550 · DOI 10.1007/s10029-024-03124-7

Verify or expand the search:

Other trials of Control

Trials testing the same drug.

Other recruiting trials for Incisional Hernia

Currently open trials in the same condition.

Other Hospital de Mataró trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03495557.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing