Mesh Versus Suture Repair for Umbilical Hernias

Study Overview
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Brief Summary
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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.

Detailed Description
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Purpose 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. Study design Randomised controlled, double blinded, multi-centre trial. 300 consecutive patients with an umbilical hernia will be included in the study. Patients will be randomised in one of two groups of 150 patients each. Group 1 will include patients that will undergo primary (suture) repair; group 2 umbilical hernias will be repaired using a pre-peritoneal, flat polypropylene mesh in a tension free fashion. Stratification will be utilized for the size of the hernia (1-2 cm or ≥2-4 cm) and the participating centre. Patients will visit the outpatient clinic after 2-3 weeks and after 3, 12 and 24 months. The cumulative hernia recurrence rate during the 2-years follow-up period will be the primary outcome of the study. Complications, pain and QOL are secondary endpoints. Statistical analysis All analyses will be performed according to the intention to treat principle and as specified in the protocol. Financial support None.

Official Title
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Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial

Conditions
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Umbilical Hernia

Intervention / Treatment
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* Procedure: primary suture closure
* Device: mesh enforced closure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Suture versus mesh repair in umbilical hernia patients
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: primary suture<br> | Procedure: primary suture closure<br>* primary suture closure of hernia<br>|
| Active Comparator: mesh enforced closure<br> | Device: mesh enforced closure<br>* mesh enforced closure of hernia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hernia recurrence rate |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative morbidity and complications |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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umbilical, mesh, hernia