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Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00311935
Enrollment
350
Registered
2006-04-06
Start date
2006-04-30
Completion date
2010-05-31
Last updated
2009-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Inguinal

Keywords

Hernia, Inguinal, Groin, Laparoscopic, Open, Abdominal wall

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.

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.

Interventions

PROCEDUREmethod of hernia repair

Sponsors

Tyco Healthcare Group
CollaboratorINDUSTRY
Waitemata District Health Board
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
15 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Hernia recurrence rates at 2 years post surgery.

Secondary

MeasureTime frame
Duration of procedure.
Cost of equipment use.
Rate of conversion to open procedure
Complication rates.
Time to return to work and usual activities.
Pain scores and analgesic use.
Length of hospital stay.

Countries

New Zealand

Contacts

Primary ContactMichael Rodgers, MBCHB, FRACS
michael.rodgers@waitematadhb.govt.nz+64 9 486 8920
Backup ContactHisham Hammodat, MBCHB, FRACS
hisham.hammodat@waitematadhb.govt.nz+64 9 486 8920

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026