Skip to main content
MedPathMedPath Home
Clinical Trials/NCT00393887
NCT00393887
Completed
Not Applicable

Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

Cook Group Incorporated1 site in 1 country100 target enrollmentMarch 2007
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsInguinal Hernia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Inguinal Hernia
Sponsor
Cook Group Incorporated
Enrollment
100
Locations
1
Primary Endpoint
Number of Patients With Inguinal Hernia Recurrence
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

Aim is to evaluate outcomes of inguinal hernia repair incorporating the standard Lichtenstein (open) repair using Biodesign IHM in a double blind (physician evaluator and patient will be blinded), randomized, prospective comparative study with polypropylene mesh. Primary outcome is recurrence at 1 year. Hernia recurrence will be confirmed via ultrasound or CT scan.

Registry
clinicaltrials.gov
Start Date
March 2007
End Date
June 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Number of Patients With Inguinal Hernia Recurrence

Time Frame: 1 year

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
A Multi-site Trial Comparing Lichtensteins Operation and Prolene Hernia System in Inguinal HErnia RepairInguinal Hernia
NCT00184483Norwegian University of Science and Technology405
Unknown
Not Applicable
Laparoscopic Inguinal Hernia Repair- Transabdominal Preperitoneal (TAPP) Versus Totally Extra Peritoneal (TEP)Laparoscopic Inguinal Hernia Repair
NCT00687375All India Institute of Medical Sciences, New Delhi90
Completed
Not Applicable
Comparison of Three Meshes in Lichtenstein Hernia RepairChronic PainRecurrences
NCT01295437Kuopio University Hospital300
Completed
Not Applicable
Comparative Study Between Lap. Dual Approach, Lap. Trans Abdominal Pre-peritoneal and Lichtenstein ProceduresInguinal Hernioplasty
NCT03052023Assiut University60
Unknown
Not Applicable
Prospective Randomized Trial Comparing Three-port and Single-port TEP Repair in AdultsInguinal Hernia
NCT01591395Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation100