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Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Ruth Kaufmann, MD, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT00789230
First received: November 9, 2008
Last updated: April 3, 2014
Last verified: April 2014

November 9, 2008
April 3, 2014
January 2006
March 2016   (final data collection date for primary outcome measure)
hernia recurrence rate [ Time Frame: 24 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Umbilical Hernia
  • Procedure: primary suture closure
    primary suture closure of hernia
  • Procedure: mesh enforced closure
    mesh enforced closure of hernia
  • Active Comparator: primary suture
    Intervention: Procedure: primary suture closure
  • Active Comparator: mesh enforced closure
    Intervention: Procedure: 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.
 
Active, not recruiting
300
March 2016
March 2016   (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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Netherlands
 
NCT00789230
HUMP
Yes
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 2014

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