Overview

This trial is active, not recruiting.

Condition umbilical hernia
Treatments primary suture closure, mesh enforced closure
Phase phase 3
Sponsor Ruth Kaufmann, MD
Start date January 2006
End date March 2016
Trial size 300 participants
Trial identifier NCT00789230, HUMP

Summary

The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). Especially risk factors for hernia recurrence such as hernia size and BMI > 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
primary suture closure
primary suture closure of hernia
(Active Comparator)
mesh enforced closure
mesh enforced closure of hernia

Primary Outcomes

Measure
hernia recurrence rate
time frame: 24 months

Secondary Outcomes

Measure
Post-operative morbidity and complications
time frame: 3 months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Primary umbilical hernia - Signed Informed consent Exclusion Criteria: - Umbilical hernia ≥ 4 cm diameter - Recurrence - Midline laparotomy - Ascites/Cirrhosis - ASA score IV or above - Incarcerated hernia/emergency procedures

Additional Information

Official title Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial
Principal investigator J. Jeekel, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in April 2014.
Information provided to ClinicalTrials.gov by Erasmus Medical Center.