Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00311935




Registration number
NCT00311935
Ethics application status
Date submitted
5/04/2006
Date registered
6/04/2006
Date last updated
3/02/2009

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

Intervention/exposure
Study type
Interventional
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

Outcomes
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

Eligibility
Key inclusion criteria
- Male <60yrs with primary inguinal hernia
Minimum age
15 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
- Recurrent hernia

- Bilateral hernia

- Non-reducible/obstructed hernia

- Previous lower abdominal surgery/radiotherapy

Study design
Purpose of the study
Treatment
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2006
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2010
Actual
Sample size
Target
350
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Waitemata District Health Board
Address
Country
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

Summary
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
https://clinicaltrials.gov/ct2/show/NCT00311935
Trial related presentations / publications
Public notes

Contacts
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00311935