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Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2014 by Erasmus Medical Center.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Ruth Kaufmann, MD, Erasmus Medical Center Identifier:
First received: November 9, 2008
Last updated: April 3, 2014
Last verified: April 2014
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 Intervention Phase
Umbilical Hernia
Procedure: primary suture closure
Procedure: mesh enforced closure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial

Resource links provided by NLM:

Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • hernia recurrence rate [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • Post-operative morbidity and complications [ Time Frame: 3 months ]

Enrollment: 300
Study Start Date: January 2006
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: primary suture Procedure: primary suture closure
primary suture closure of hernia
Active Comparator: mesh enforced closure Procedure: mesh enforced closure
mesh enforced closure of hernia


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

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
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Please refer to this study by its identifier: NCT00789230

Studienzentrum der Deutschen Gesellschaft für Chirurgie
Heidelberg, Germany
University of Witten/Herdecke
Witten, Germany
Milano, Italy
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
Rotterdam, Netherlands
Rotterdam, Netherlands
Maasstad Ziekenhuis
Rotterdam, Netherlands
Máxima Medisch Centrum
Veldhoven, Netherlands
Zwolle, Netherlands
Sponsors and Collaborators
Ruth Kaufmann, MD
Principal Investigator: J. Jeekel, MD, PhD Erasmus Medical Center
Principal Investigator: J.F. Lange, MD, PhD Erasmus Medical Center
  More Information

Responsible Party: Ruth Kaufmann, MD, R. Kaufmann, Erasmus Medical Center Identifier: NCT00789230     History of Changes
Other Study ID Numbers: HUMP
Study First Received: November 9, 2008
Last Updated: April 3, 2014

Keywords provided by Erasmus Medical Center:

Additional relevant MeSH terms:
Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal processed this record on March 27, 2017