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Sponsors and Collaborators: |
Waitemata District Health Board Tyco Healthcare |
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Information provided by: | Waitemata District Health Board |
ClinicalTrials.gov Identifier: | NCT00311935 |
This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group.
The overall financial costs of each repair will also be compared.
Condition | Intervention |
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Hernia, Inguinal |
Procedure: method of hernia repair |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60 |
Estimated Enrollment: | 350 |
Study Start Date: | April 2006 |
Estimated Study Completion Date: | May 2010 |
Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study. Randomized to open mesh repair or laparoscopic preperitoneal mesh repair. Two surgeons (Dr Rodgers and Dr Hammodat) using a standardized technique. Conversion rates from lap to open will be recorded.
Phone assessment postop day 1, 1 week and at 6 months. Clinic assessment at 4 weeks, 1 year and 2 years.
Primary outcome is hernia recurrence which will be assessed by a research nurse independent of surgeon at each clinic appointment. Assessment to also include assessment of ongoing symptoms such as pain/discomfort, sensory disturbance, and sexual dysfunction.
Quality of life assessment (SF 36 questionnaire) preoperatively and at each assessment.
Pain assessment 4hrs postop and at all other assessments by score 0-10 and measurement of pain relief.
Cost analysis to include the following parameters: theatre equipment costs, theatre time, drug use, hospital stay, time to return to work, time to return to normal activities.
Interim analysis at 2 years of followup by independent Health and Safety committee. Final analysis at 4 years of followup.
Ages Eligible for Study: | 15 Years to 60 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Rodgers, MBCHB, FRACS | +64 9 486 8920 ext 3152 | michael.rodgers@waitematadhb.govt.nz |
Contact: Hisham Hammodat, MBCHB, FRACS | +64 9 486 8920 ext 2459 | hisham.hammodat@waitematadhb.govt.nz |
New Zealand | |
Waitemata District Health Board | Recruiting |
Auckland, New Zealand |
Principal Investigator: | Michael Rodgers, MBCHB,FRACS | Waitemata District Health Board |
Study ID Numbers: | Hernia repair study |
Study First Received: | April 5, 2006 |
Last Updated: | February 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00311935 History of Changes |
Health Authority: | New Zealand: Health and Disability Ethics Committees |
Hernia Inguinal Groin |
Laparoscopic Open Abdominal wall |
Pathological Conditions, Anatomical Hernia Hernia, Abdominal Hernia, Inguinal |
Pathological Conditions, Anatomical Hernia Hernia, Abdominal Hernia, Inguinal |