Mesh Versus Suture Repair for Umbilical Hernias

Not Applicable

Completed

• Conditions: Umbilical Hernia
• Interventions: Device: mesh enforced closure; Procedure: primary suture closure

• Registration Number: NCT00789230
• Lead Sponsor: Ruth Kaufmann, MD

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2008-11-09
• Study First Submitted QC: 2008-11-09
• Study First Posted: 2008-11-11
• Primary Completion: 2015-04
• Study Completion: 2015-08
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-22
• Last Update Posted: 2018-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mesh enforced closure	mesh enforced closure	-
primary suture	primary suture closure	-

Primary Outcome Measures

Name	Time	Method
hernia recurrence rate	24 months

Secondary Outcome Measures

Name	Time	Method
Post-operative morbidity and complications	3 months

Trial Locations

Locations (12)

Havenziekenhuis; 🇳🇱 Rotterdam, Netherlands

Máxima Medisch Centrum; 🇳🇱 Veldhoven, Netherlands

Isala; 🇳🇱 Zwolle, Netherlands

Erasmus University Medical Center; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

Maasstad Ziekenhuis; 🇳🇱 Rotterdam, Netherlands

Studienzentrum der Deutschen Gesellschaft für Chirurgie; 🇩🇪 Heidelberg, Germany

Multimedica; 🇮🇹 Milano, Italy

Onze Lieve Vrouwe Gasthuis; 🇳🇱 Amsterdam, Netherlands

Wilhelmina Ziekenhuis; 🇳🇱 Assen, Netherlands

Reinier de Graaf Gasthuis; 🇳🇱 Delft, Netherlands

Ikazia; 🇳🇱 Rotterdam, Netherlands

University of Witten/Herdecke; 🇩🇪 Witten, Germany