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NCT00393887 Clinical Trial

Inguinal Hernia Study Using Biodesign IHM

Inguinal Hernia Clinical Trial

Official title:
Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00393887
Other study ID # H-28044
Secondary ID 05-003
Status Completed
Phase N/A
First received October 26, 2006
Last updated October 16, 2015
Start date March 2007
Est. completion date June 2014

Study information
Verified date October 2015
Source Cook
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Biodesign IHM
Biodesign IHM is placed to reinforce the hernia repair
• Polypropylene mesh
Polypropylene mesh is used to reinforce the hernia repair.

Locations
Country Name City State
United States University of Maryland Baltimore Maryland

Sponsors (3)
Lead Sponsor Collaborator
Cook Cook Biotech Incorporated, MED Institute, Incorporated

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Patients With Inguinal Hernia Recurrence 1 year Yes
See also
  Status Clinical Trial Phase
Completed NCT03023462 - Efficacy of an Anterior Quadratus Lumborum Block vs. a TAP-block for Inguinal Hernia Repair N/A
Completed NCT04272320 - The Efficacy of Transversalis Fascia Plane Block in Pediatric Inguinal Hernia Repair N/A
Recruiting NCT03904888 - Conventional Versus Robot Assisted Laparoscopic Inguinal Hernia Repair N/A
Recruiting NCT03856710 - Self Fixating Versus Stapled Mesh for Laparoscopic Inguinal Hernia Repair N/A
Completed NCT02240550 - A Comparative Clinical Study to Evaluate the Effectiveness of ProFlor vs. Lichtenstein for Inguinal Hernia Repair N/A
Completed NCT01943760 - Tamadol Wound Infiltration in Children Under Inguinal Hernioplasty Phase 4
Completed NCT01679353 - Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair N/A
Recruiting NCT01450345 - Efficacy of Pre-operative Oral Pregabalin in Ambulatory Inguinal Hernia Repair for Post Operative Pain Phase 3
Active, not recruiting NCT00968773 - Rebound Hernia Repair Device Mesh Trial Phase 4
Completed NCT01000116 - Fibrin Glue Versus Tacked Fixation in Groin Hernia Repair (TAPP) N/A
Completed NCT01117337 - Comparing Non-fixation of Mesh to Mesh Fixation in Laparoscopic Inguinal Hernia Repair Phase 4
Terminated NCT00226161 - Chronic Pain After Inguinal Herniorrhaphy N/A
Completed NCT05837013 - Open and Laparoscopic Total Extraperitoneal Repair Under Spinal Anesthesia Versus General Anesthesia N/A
Recruiting NCT05058378 - Correlation Between Spinal Anesthesia and Perfusion Index
Completed NCT01637818 - Long-term Follow-up of Lichtenstein's Operation Versus Mesh Plug Repair N/A
Recruiting NCT05879770 - Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Completed NCT05159232 - Length of Hospital Stay in Laparoscopic Transabdominal Preperitoneal Vs. Open Mesh Repair in Inguinal Hernia: A Randomised Controlled Trial N/A
Completed NCT05107986 - Laparoscopy in Complicated Groin Hernia
Active, not recruiting NCT04328597 - Portuguese Inguinal Hernia Cohort (PINE) Study
Completed NCT04033055 - Antalgic Efficacy of CycloMesh™ Soaked in Ropivacaine Hydrochloride in Uncomplicated Inguinal Hernia. N/A

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