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
  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.


Condition Intervention Phase
Umbilical Hernia
Procedure: primary suture closure
Procedure: mesh enforced closure
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post-operative morbidity and complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789230

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

No publications provided

Responsible Party: Ruth Kaufmann, MD, R. Kaufmann, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT00789230     History of Changes
Other Study ID Numbers: HUMP
Study First Received: November 9, 2008
Last Updated: April 3, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
umbilical
hernia
mesh

Additional relevant MeSH terms:
Hernia
Hernia, Umbilical
Pathological Conditions, Anatomical
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal

ClinicalTrials.gov processed this record on July 28, 2014