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Completed

NCT Number: NCT00393887

Inguinal Hernia Study Using Biodesign IHM

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maryland

Baltimore, Maryland, 21201, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biodesign IHM

Device

Biodesign IHM is placed to reinforce the hernia repair

Other names: SurgiSIS IHM

Polypropylene mesh

Device

Polypropylene mesh is used to reinforce the hernia repair.

Primary outcomes

  1. Number of Patients With Inguinal Hernia Recurrence

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Collaborators

  • Cook Biotech Incorporated
  • MED Institute, Incorporated

Registry information

Official study title

Inguinal Hernia Study: A Double Blinded Randomized Prospective Study

Important dates

Study start
2007
Primary completion
2014
Study completion
2014
First posted
Oct 30, 2006
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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