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Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ruth Kaufmann, MD, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00789230
First received: November 9, 2008
Last updated: April 5, 2017
Last verified: April 2017

November 9, 2008
April 5, 2017
January 2006
April 2015   (Final data collection date for primary outcome measure)
hernia recurrence rate [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT00789230 on ClinicalTrials.gov Archive Site
Post-operative morbidity and complications [ Time Frame: 3 months ]
Same as current
Not Provided
Not Provided
 
Mesh Versus Suture Repair for Umbilical Hernias
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Suture versus mesh repair in umbilical hernia patients
Masking: Participant, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Umbilical Hernia
  • Procedure: primary suture closure
    primary suture closure of hernia
  • Device: mesh enforced closure
    mesh enforced closure of hernia
  • Active Comparator: primary suture
    Intervention: Procedure: primary suture closure
  • Active Comparator: mesh enforced closure
    Intervention: Device: mesh enforced closure
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
300
August 2015
April 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Netherlands
 
 
NCT00789230
HUMP
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
No
Not Provided
Ruth Kaufmann, MD, Erasmus Medical Center
Ruth Kaufmann, MD
Not Provided
Principal Investigator: J. Jeekel, MD, PhD Erasmus Medical Center
Principal Investigator: J.F. Lange, MD, PhD Erasmus Medical Center
Erasmus Medical Center
April 2017

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