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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
NA
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