Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

Hernia, Inguinal Clinical Trial

Official title:

Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00311935
• Other study ID #: Hernia repair study
• Status: Recruiting
• Phase: N/A
• First received: April 5, 2006
• Last updated: February 2, 2009
• Start date: April 2006
• Est. completion date: May 2010

Study information

• Verified date: February 2009
• Source: Waitemata District Health Board
• Contact: Michael Rodgers, MBCHB, FRACS
• Phone: +64 9 486 8920
• Email: michael.rodgers[@]waitematadhb.govt.nz
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Male <60yrs with primary inguinal hernia

Exclusion Criteria:

• Recurrent hernia

• Bilateral hernia

• Non-reducible/obstructed hernia

• Previous lower abdominal surgery/radiotherapy

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• method of hernia repair

Locations

Country	Name	City	State
New Zealand	Waitemata District Health Board	Auckland

Sponsors (2)

Lead Sponsor	Collaborator
Waitemata District Health Board	Tyco Healthcare Group

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hernia recurrence rates at 2 years post surgery.
Secondary	Complication rates.
Secondary	Duration of procedure.
Secondary	Cost of equipment use.
Secondary	Rate of conversion to open procedure
Secondary	Length of hospital stay.
Secondary	Time to return to work and usual activities.
Secondary	Pain scores and analgesic use.