Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair (Dangrip)
This study has been completed.
Sponsor:
Jacob Rosenberg
Collaborators:
Bispebjerg Hospital
University Hospital, Gentofte, Copenhagen
Frederikshavn Hospital
Nyborg Hospital
Information provided by (Responsible Party):
Jacob Rosenberg, Herlev Hospital
ClinicalTrials.gov Identifier:
NCT00815698
First received: December 29, 2008
Last updated: March 27, 2013
Last verified: March 2013
| Tracking Information | |||||
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| First Received Date ICMJE | December 29, 2008 | ||||
| Last Updated Date | March 27, 2013 | ||||
| Start Date ICMJE | December 2008 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
pain, numbness and discomfort in the groin [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00815698 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
recurrence, satisfaction and quality of life [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ] | ||||
| 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 | Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair | ||||
| Official Title ICMJE | Effect of Suture for Mesh Fixation in Lichtenstein Hernia Repair, a Prospective Controlled Randomized Trial | ||||
| Brief Summary | The investigators want to evaluate the effect of suturing the mesh versus using a self-adhesive mesh for Lichtenstein hernia repair. Effect parameters include chronic pain. |
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| Detailed Description | Pain is a frequent problem after open inguinal hernia repair. The most frequent operative technique for inguinal hernia repair in adults is the Lichtenstein mesh repair, where a polypropylene mesh is sutured to the tissue in the inguinal region. We therefore want to evaluate the effect of suture for mesh fixation on the occurrence of chronic pain 12 months after operation. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
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| Condition ICMJE | Inguinal Hernia | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * |
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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 | 334 | ||||
| Completion Date | September 2011 | ||||
| Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00815698 | ||||
| Other Study ID Numbers ICMJE | CPODenmark001 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Jacob Rosenberg, Herlev Hospital | ||||
| Study Sponsor ICMJE | Jacob Rosenberg | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Herlev Hospital | ||||
| Verification Date | March 2013 | ||||
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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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