Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

• Sponsor: Waitemata District Health Board (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00311935
• Collaborator: Tyco Healthcare Group (Industry)
• Enrollment: 350
• Location: 1
• Duration (Months): 49
• Patients Per Site Per Month: 7.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Hernia, Inguinal	Procedure: method of hernia repair	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 350 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
• Study Start Date: Apr 1, 2006
• Anticipated Study Completion Date: May 1, 2010

Outcome Measures

Primary Outcome Measures

1. Hernia recurrence rates at 2 years post surgery. []

Secondary Outcome Measures

1. Complication rates. []

2. Duration of procedure. []

3. Cost of equipment use. []

4. Rate of conversion to open procedure []

5. Length of hospital stay. []

6. Time to return to work and usual activities. []

7. Pain scores and analgesic use. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years to 60 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male <60yrs with primary inguinal hernia

Exclusion Criteria:

• Recurrent hernia

• Bilateral hernia

• Non-reducible/obstructed hernia

• Previous lower abdominal surgery/radiotherapy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Waitemata District Health Board	Auckland		New Zealand

Sponsors and Collaborators

• Waitemata District Health Board
• Tyco Healthcare Group

Investigators

• Principal Investigator: Michael Rodgers, MBCHB,FRACS, Waitemata District Health Board

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00311935
• Other Study ID Numbers: Hernia repair study
• First Posted: Apr 6, 2006
• Last Update Posted: Feb 3, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Hernia; Inguinal; Groin; Laparoscopic; Open; Abdominal wall
• Additional relevant MeSH terms: Hernia; Hernia, Inguinal

Study Results

No Results Posted as of Feb 3, 2009