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Mesh Versus Suture Repair for Umbilical Hernias (HUMP)
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| First Received Date ICMJE | November 9, 2008 | ||||||||
| Last Updated Date | April 5, 2017 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
hernia recurrence rate [ Time Frame: 24 months ] | ||||||||
| 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 ] | ||||||||
| 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 | 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. Study design Randomised controlled, double blinded, multi-centre trial. 300 consecutive patients with an umbilical hernia will be included in the study. Patients will be randomised in one of two groups of 150 patients each. Group 1 will include patients that will undergo primary (suture) repair; group 2 umbilical hernias will be repaired using a pre-peritoneal, flat polypropylene mesh in a tension free fashion. Stratification will be utilized for the size of the hernia (1-2 cm or ≥2-4 cm) and the participating centre. Patients will visit the outpatient clinic after 2-3 weeks and after 3, 12 and 24 months. The cumulative hernia recurrence rate during the 2-years follow-up period will be the primary outcome of the study. Complications, pain and QOL are secondary endpoints. Statistical analysis All analyses will be performed according to the intention to treat principle and as specified in the protocol. Financial support None. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Suture versus mesh repair in umbilical hernia patients Masking: Participant, Investigator, Outcomes AssessorPrimary Purpose: Treatment |
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| Condition ICMJE | Umbilical Hernia | ||||||||
| Intervention ICMJE |
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| Study Arms |
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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 | Completed | ||||||||
| Enrollment ICMJE | 300 | ||||||||
| Completion Date | August 2015 | ||||||||
| Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| 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 | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Ruth Kaufmann, MD, Erasmus Medical Center | ||||||||
| Study Sponsor ICMJE | Ruth Kaufmann, MD | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | Erasmus Medical Center | ||||||||
| Verification Date | April 2017 | ||||||||
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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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