Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

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

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 Overview

• Status: Completed
• Conditions: Umbilical Hernia
• Intervention / Treatment: Procedure: primary suture closure; Device: mesh enforced closure

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 Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Heidelberg, Germany
    • Studienzentrum der Deutschen Gesellschaft für Chirurgie
  • Witten, Germany
    • University of Witten/Herdecke
• Italy
  • Milano, Italy
    • Multimedica
• Netherlands
  • Amsterdam, Netherlands
    • Onze Lieve Vrouwe Gasthuis
  • Assen, Netherlands
    • Wilhelmina Ziekenhuis
  • Delft, Netherlands
    • Reinier de Graaf Gasthuis
  • Rotterdam, Netherlands
    • Maasstad Ziekenhuis
  • Rotterdam, Netherlands
    • Ikazia
  • Rotterdam, Netherlands
    • Havenziekenhuis
  • Veldhoven, Netherlands
    • Máxima Medisch Centrum
  • Zwolle, Netherlands
    • Isala
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015CN
      • Erasmus University Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
hernia recurrence rate	24 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ruth Kaufmann, MD
• Investigators: Principal Investigator: J. Jeekel, MD, PhD, Erasmus Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2006
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: November 9, 2008
• First Submitted That Met QC Criteria: November 9, 2008
• First Posted (Estimate): November 11, 2008

Study Record Updates

• Last Update Posted (Actual): February 26, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: hernia; mesh; umbilical
• Additional Relevant MeSH Terms: Infant, Newborn, Diseases; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia, Ventral; Hernia; Hernia, Umbilical
• Other Study ID Numbers: HUMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No