NCT00789230

Mesh Versus Suture Repair for Umbilical Hernias

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Ruth Kaufmann, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Umbilical Hernia

Interventions

Type	Name	Description
PROCEDURE	primary suture closure	primary suture closure of hernia
DEVICE	mesh enforced closure	mesh enforced closure of hernia

Timeline

• Start date: 2006-01-01
• Primary completion: 2015-04-01
• Completion: 2015-08-01
• First posted: 2008-11-11
• Last updated: 2018-02-26

Locations

12 sites across 3 countries: Germany, Italy, Netherlands