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Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00789230
Recruitment Status : Completed
First Posted : November 11, 2008
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
Ruth Kaufmann, MD, Erasmus Medical Center

Tracking Information
First Submitted Date  ICMJE November 9, 2008
First Posted Date  ICMJE November 11, 2008
Last Update Posted Date February 26, 2018
Study Start Date  ICMJE January 2006
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 9, 2008)
hernia recurrence rate [ Time Frame: 24 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 9, 2008)
Post-operative morbidity and complications [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesh Versus Suture Repair for Umbilical Hernias
Official Title  ICMJE Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Umbilical Hernia
Intervention  ICMJE
  • Procedure: primary suture closure
    primary suture closure of hernia
  • Device: mesh enforced closure
    mesh enforced closure of hernia
Study Arms  ICMJE
  • Active Comparator: primary suture
    Intervention: Procedure: primary suture closure
  • Active Comparator: mesh enforced closure
    Intervention: Device: mesh enforced closure
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 9, 2008)
300
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany,   Italy,   Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00789230
Other Study ID Numbers  ICMJE HUMP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ruth Kaufmann, MD, Erasmus Medical Center
Original Responsible Party Professor Dr. J. Jeekel, ErasmusMedical Center Rotterdam
Current Study Sponsor  ICMJE Ruth Kaufmann, MD
Original Study Sponsor  ICMJE Erasmus Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: J. Jeekel, MD, PhD Erasmus Medical Center
Principal Investigator: J.F. Lange, MD, PhD Erasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP