The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia
Scientific title
Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
Secondary ID [1] 0 0
Hernia repair study
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hernia, Inguinal 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Study type
Description of intervention(s) / exposure
Treatment: Surgery - method of hernia repair

Treatment: Surgery: method of hernia repair

Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Hernia recurrence rates at 2 years post surgery.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Complication rates.
Timepoint [1] 0 0
Secondary outcome [2] 0 0
Duration of procedure.
Timepoint [2] 0 0
Secondary outcome [3] 0 0
Cost of equipment use.
Timepoint [3] 0 0
Secondary outcome [4] 0 0
Rate of conversion to open procedure
Timepoint [4] 0 0
Secondary outcome [5] 0 0
Length of hospital stay.
Timepoint [5] 0 0
Secondary outcome [6] 0 0
Time to return to work and usual activities.
Timepoint [6] 0 0
Secondary outcome [7] 0 0
Pain scores and analgesic use.
Timepoint [7] 0 0

Key inclusion criteria
- Male <60yrs with primary inguinal hernia
Minimum age
15 Years
Maximum age
60 Years
Can healthy volunteers participate?
Key exclusion criteria
- Recurrent hernia

- Bilateral hernia

- Non-reducible/obstructed hernia

- Previous lower abdominal surgery/radiotherapy

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0

Funding & Sponsors
Primary sponsor type
Waitemata District Health Board
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Tyco Healthcare Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Michael Rodgers, MBCHB,FRACS
Address 0 0
Waitemata District Health Board
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Michael Rodgers, MBCHB, FRACS
Address 0 0
Country 0 0
Phone 0 0
+64 9 486 8920
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see