Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

NCT ID: NCT00311935

Last Updated: 2009-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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method of hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Male \<60yrs with primary inguinal hernia

Exclusion Criteria

* Recurrent hernia
* Bilateral hernia
* Non-reducible/obstructed hernia
* Previous lower abdominal surgery/radiotherapy
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Tyco Healthcare Group

INDUSTRY

Sponsor Role collaborator

Waitemata District Health Board

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Michael Rodgers, MBCHB,FRACS

Role: PRINCIPAL_INVESTIGATOR

Waitemata District Health Board

Locations

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Waitemata District Health Board

Auckland, , New Zealand

Site Status RECRUITING

Countries

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New Zealand

Central Contacts

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Michael Rodgers, MBCHB, FRACS

Role: CONTACT

+64 9 486 8920 ext. 3152

Hisham Hammodat, MBCHB, FRACS

Role: CONTACT

+64 9 486 8920 ext. 2459

Other Identifiers

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Hernia repair study

Identifier Type: -

Identifier Source: org_study_id

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