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23 May 2012
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| [ Print-friendly version ] |
| Inguinal Hernia Study Using Surgisis IHM |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | Inguinal Hernia Study Using Surgisis IHM |
| Current status of trial | Active, not recruiting |
| Sponsors and collaborators | Cook Cook Biotech Incorporated MED Institute, Incorporated |
| Information provided by | Cook |
| ClinicalTrials.gov identifier | NCT00393887 |
| Purpose | Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Surgisis IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Outcomes are recurrence, return to full activities, pain, seroma rates and complications. Patients will be followed at 2 weeks, 3 months, and 6 months post-operatively, and every 6 months after that for 3 years. Hernia recurrence will be confirmed via ultrasound or CT scan. |
| Condition(s) | Inguinal Hernia |
| Intervention(s) | Device: Surgisis IHM Device: Prolene |
| Phase | N/A |
| Study type and 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 | Inguinal Hernia Study: A Double Blinded Randomized Prospective Study |
| Primary outcome | Recurrence rate 3 years No |
| Secondary outcome | Time back to baseline and complications 3 years Yes |
| Study start | March 2007 |
| Minimum age | 18 Years |
| Maximum age | N/A |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - 18 years of age - Diagnosis of Unilateral inguinal hernia repair - Able to provide written consent Exclusion Criteria: - Incarcerated hernia - Allergic or religious beliefs that disallow porcine material - Previous hernia repair on the designated hernia site - Class IV or V anesthesia requirements - Bowel obstruction - Peritonitis - Life expectancy < 3 years |
| Study chairs or principal investigators | Ajay Jain, M.D., Principal Investigator, University of Maryland |
| Locations | Maryland, United States University of Maryland Baltimore Maryland 21201 |
| Study ID numbers | H-28044; 05-003 |
| Last updated | December 14, 2011 |
| Record first received | October 26, 2006 |
| ClinicalTrials.gov identifier | NCT00393887 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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