Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia
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|ClinicalTrials.gov Identifier: NCT00311935|
Recruitment Status : Unknown
Verified February 2009 by Waitemata District Health Board.
Recruitment status was: Recruiting
First Posted : April 6, 2006
Last Update Posted : February 3, 2009
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal||Procedure: method of hernia repair||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||350 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60|
|Study Start Date :||April 2006|
|Estimated Study Completion Date :||May 2010|
- Hernia recurrence rates at 2 years post surgery.
- Complication rates.
- Duration of procedure.
- Cost of equipment use.
- Rate of conversion to open procedure
- Length of hospital stay.
- Time to return to work and usual activities.
- Pain scores and analgesic use.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00311935
|Contact: Michael Rodgers, MBCHB, FRACS||+64 9 486 8920 ext firstname.lastname@example.org|
|Contact: Hisham Hammodat, MBCHB, FRACS||+64 9 486 8920 ext email@example.com|
|Waitemata District Health Board||Recruiting|
|Auckland, New Zealand|
|Principal Investigator:||Michael Rodgers, MBCHB,FRACS||Waitemata District Health Board|