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Mesh Versus Suture Repair in Umbilical Hernias - A Multicenter Trial

NCT04231071 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 288

Last updated 2024-02-06

No results posted yet for this study

Summary

Umbilical hernia repair is one of the most common surgical performance in general surgery. Up to now, the use of suture repair has been the preferred technique for small umbilical hernia defects without any gold standard procedure. Mesh have been reserved to larger umbilical hernia defects. However, there is an increasing evidence that mesh reinforcement could be advantageous to lower the high recurrence rates also in smaller umbilical hernias. A remained important question is in what anatomical position the mesh should be placed. The investigators hypothesize that the use of an onlay mesh in small umbilical hernia defects can reduces recurrence rates without increasing postoperative complications compared to a suture repair.

Conditions

  • Umbilical Hernia

Interventions

DEVICE

Onlay Mesh group

Primary suture repair with a small only mesh on the closed defect

Sponsors & Collaborators

Principal Investigators

  • Björn Widhe, MD, PhD · Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet

  • Sven Bringman, MD, PhD · Department of Clinical Sciences, Danderyds Hospital, Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-03
Primary Completion
2024-01-03
Completion
2024-01-03

Countries

  • Sweden

Study Locations

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Entities

Companies

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 NCT04231071 on ClinicalTrials.gov