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Preemer Trial - Prophylactic Mesh Versus no Mesh in the Midline Emergency Laparotomy Closure for Prevention of Incisional Hernia: a Multi Center, Double-blind, Randomized Controlled Trial

NCT04311788 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 109

Last updated 2024-02-01

No results posted yet for this study

Summary

244 patients, who have an emergency midline laparotomy for any gastrointestinal reason, will be randomized in a 1:1 ratio either to mesh group with a retrorectus prophylactic self-gripping mesh or to control group with 4:1 small stitch closure by continuous monofilament suture. They will be followed up at 30 days, 2 and 5 years to detect the incidence of incisional hernia.

Conditions

  • Incisional Hernia
  • Emergency Laparotomy
  • Midline Laparotomy
  • Hernia Prevention

Interventions

DEVICE

Prophylactic self gripping mesh

Prophylactic self gripping mesh, Propgrip by Medtronic.

DEVICE

Slowly absorbable continuous monofilament suture

Fascial closure by continuous slowly absorbable 4:1 suture

Sponsors & Collaborators

  • Helsinki University Central Hospital

    collaborator OTHER

  • University of Oulu

    lead OTHER

Principal Investigators

  • Elisa Mäkäräinen-Uhlbäck, M.D. · Oulu University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-27
Primary Completion
2025-02-03
Completion
2028-03-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04311788 on ClinicalTrials.gov