Mesh Versus Suture Repair for Umbilical Hernias

NCT ID: NCT00789230

Last Updated: 2018-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2015-08-31

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.

Conditions

Umbilical Hernia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

primary suture

Group Type: ACTIVE_COMPARATOR

primary suture closure

Intervention Type: PROCEDURE

primary suture closure of hernia

mesh enforced closure

Group Type: ACTIVE_COMPARATOR

mesh enforced closure

Intervention Type: DEVICE

mesh enforced closure of hernia

Interventions

primary suture closure

primary suture closure of hernia

Intervention Type: PROCEDURE

mesh enforced closure

mesh enforced closure of hernia

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruth Kaufmann, MD

OTHER

Sponsor Role: lead

Responsible Party

Ruth Kaufmann, MD

R. Kaufmann

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

J. Jeekel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

J.F. Lange, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

Studienzentrum der Deutschen Gesellschaft für Chirurgie

Heidelberg, , Germany

University of Witten/Herdecke

Witten, , Germany

Multimedica

Milan, , Italy

Erasmus University Medical Center

Rotterdam, South Holland, Netherlands

Onze Lieve Vrouwe Gasthuis

Amsterdam, , Netherlands

Wilhelmina Ziekenhuis

Assen, , Netherlands

Reinier de Graaf Gasthuis

Delft, , Netherlands

Havenziekenhuis

Rotterdam, , Netherlands

Ikazia

Rotterdam, , Netherlands

Maasstad Ziekenhuis

Rotterdam, , Netherlands

Máxima Medisch Centrum

Veldhoven, , Netherlands

Isala

Zwolle, , Netherlands

Countries

Germany; Italy; Netherlands

References

Kaufmann R, Halm JA, Eker HH, Klitsie PJ, Nieuwenhuizen J, van Geldere D, Simons MP, van der Harst E, van 't Riet M, van der Holt B, Kleinrensink GJ, Jeekel J, Lange JF. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018 Mar 3;391(10123):860-869. doi: 10.1016/S0140-6736(18)30298-8. Epub 2018 Feb 17.

Reference Type: DERIVED

PMID: 29459021 (View on PubMed)

Other Identifiers

HUMP

Identifier Type: -

Identifier Source: org_study_id