Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01660048




Registration number
NCT01660048
Ethics application status
Date submitted
31/07/2012
Date registered
8/08/2012
Date last updated
20/03/2013

Titles & IDs
Public title
A Prospective Study Comparing Single and Multiport Laparoscopic Inguinal Hernia Repair
Scientific title
Prospective Randomized Single Blind Controlled Study Comparing Single and Multiport Laparoscopic Total Extraperitoneal Inguinal Hernia Repair
Secondary ID [1] 0 0
Holroyd Private Hospital
Secondary ID [2] 0 0
HTranSILStrial
Universal Trial Number (UTN)
Trial acronym
SILSTEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernia 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 - SILS TEP repair
Treatment: Surgery - Total extraperitoneal inguinal hernia repair

Experimental: SILS TEP repair - Half of the patients will undergo laparoscopic total extraperitoneal inguinal hernia repair using a single port (Triport)

Active comparator: Multiports TEP repair - Half of the patients will undergo the conventional multiports total extraperitoneal inguinal hernia repair


Treatment: Surgery: SILS TEP repair
perform the laparoscopic total extraperitoneal inguinal hernia repair using a single port

Treatment: Surgery: Total extraperitoneal inguinal hernia repair
Conventional multiport laparoscopic total extraperitoneal inguinal hernia repair
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Conversion to multiport or open operation
Timepoint [1] 0 0
during operation
Secondary outcome [1] 0 0
Operating time
Timepoint [1] 0 0
during operation
Secondary outcome [2] 0 0
Length of hospital stay
Timepoint [2] 0 0
day procedure or overnight stay
Secondary outcome [3] 0 0
Pre and post operative pain scores
Timepoint [3] 0 0
preop, day one and day 7 postop
Secondary outcome [4] 0 0
Analgesic requirements
Timepoint [4] 0 0
one week
Secondary outcome [5] 0 0
return to work or normal physical activities
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
Quality of life health scores
Timepoint [6] 0 0
preop, 6 weeks and 1 year postop
Secondary outcome [7] 0 0
Cosmetic scar score
Timepoint [7] 0 0
6 weeks
Secondary outcome [8] 0 0
Recurrence of hernia
Timepoint [8] 0 0
1 year
Secondary outcome [9] 0 0
post-operative complications including urinary retention, wound infection, seroma formation, chronic pain, testicular atrophy
Timepoint [9] 0 0
6 weeks

Eligibility
Key inclusion criteria
* all referred patients with inguinal hernias
Minimum age
16 Years
Maximum age
86 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* workers Compensation cases
* previous extraperitoneal intervention
* unfit for a general anaesthetic
* strangulated hernias
* present of or previous ventral hernia repair extending 5 cm below umbilicus

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2013
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holroyd Private Hospital - Guildford
Recruitment postcode(s) [1] 0 0
2000 - Guildford

Funding & Sponsors
Primary sponsor type
Other
Name
The Sydney Hernia Specialists Clinic
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Hanh M Tran, MD, FRACS
Address 0 0
Sydney Hernia Specialists Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents


Results not provided in https://clinicaltrials.gov/study/NCT01660048