Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

• ClinicalTrials.gov Identifier: NCT00789230
• Recruitment Status: Completed
• First Posted: November 11, 2008
• Last Update Posted: February 26, 2018
• Sponsor: Ruth Kaufmann, MD
• Information provided by (Responsible Party): Ruth Kaufmann, MD, Erasmus Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Umbilical Hernia	Procedure: primary suture closure; Device: mesh enforced closure	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Suture versus mesh repair in umbilical hernia patients
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial
• Study Start Date: January 2006
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: August 2015

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: primary suture	Procedure: primary suture closure; primary suture closure of hernia
Active Comparator: mesh enforced closure	Device: mesh enforced closure; mesh enforced closure of hernia

Outcome Measures

Primary Outcome Measures :

1. hernia recurrence rate [ Time Frame: 24 months ]

Secondary Outcome Measures :

1. Post-operative morbidity and complications [ Time Frame: 3 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

Studienzentrum der Deutschen Gesellschaft für Chirurgie

Heidelberg, Germany

University of Witten/Herdecke

Witten, Germany

Italy

Multimedica

Milano, Italy

Netherlands

Erasmus University Medical Center

Rotterdam, Zuid Holland, Netherlands, 3015CN

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

Sponsors and Collaborators

Ruth Kaufmann, MD

Investigators

• Principal Investigator: J. Jeekel, MD, PhD; Erasmus Medical Center
• Principal Investigator: J.F. Lange, MD, PhD; Erasmus Medical Center

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Ruth Kaufmann, MD, R. Kaufmann, Erasmus Medical Center
• ClinicalTrials.gov Identifier: NCT00789230
• Other Study ID Numbers: HUMP
• First Posted: November 11, 2008
• Last Update Posted: February 26, 2018
• Last Verified: February 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ruth Kaufmann, MD, Erasmus Medical Center:

umbilical; hernia; mesh

Additional relevant MeSH terms:

Hernia, Umbilical; Hernia; Pathological Conditions, Anatomical; Infant, Newborn, Diseases; Hernia, Ventral; Hernia, Abdominal