Mesh Versus Suture Repair for Umbilical Hernias (HUMP)
This study is ongoing, but not recruiting participants.
Sponsor:
Ruth Kaufmann, MD
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
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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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00789230
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 | |
| Havenziekenhuis | |
| Rotterdam, Netherlands | |
| Ikazia | |
| Rotterdam, Netherlands | |
| Maasstad Ziekenhuis | |
| 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 Hernia, Abdominal |
Hernia, Ventral Infant, Newborn, Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on March 03, 2015