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
| Tracking Information | |||||||
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| First Received Date ICMJE | November 9, 2008 | ||||||
| Last Updated Date | April 3, 2014 | ||||||
| Start Date ICMJE | January 2006 | ||||||
| Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
hernia recurrence rate [ Time Frame: 24 months ] [ Designated as safety issue: No ] | ||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | Complete list of historical versions of study NCT00789230 on ClinicalTrials.gov Archive Site | ||||||
| Current Secondary Outcome Measures ICMJE |
Post-operative morbidity and complications [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] | ||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Mesh Versus Suture Repair for Umbilical Hernias | ||||||
| Official Title ICMJE | Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial | ||||||
| Brief Summary | 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. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Umbilical Hernia | ||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Enrollment ICMJE | 300 | ||||||
| Estimated Completion Date | March 2016 | ||||||
| Estimated Primary Completion Date | March 2016 (final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||
| Ages | 18 Years and older (Adult, Senior) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Germany, Italy, Netherlands | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT00789230 | ||||||
| Other Study ID Numbers ICMJE | HUMP | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| Plan to Share Data | Not Provided | ||||||
| IPD Description | Not Provided | ||||||
| Responsible Party | Ruth Kaufmann, MD, Erasmus Medical Center | ||||||
| Study Sponsor ICMJE | Ruth Kaufmann, MD | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| Information Provided By | Erasmus Medical Center | ||||||
| Verification Date | April 2014 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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