Mesh Versus Suture Repair for Umbilical Hernias (HUMP)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2014 by Erasmus Medical Center.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 (Adult, Senior) |
| 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
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
| 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 September 26, 2016