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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/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
Since laparoscopic inguinal hernia was introduced in 1990, it has now become the most
commonly performed hernia repair in NSW. Traditionally this is done with 3 small incisions: a
2 cm incision under the navel for insertion of the camera and two 1 cm incisions below the
navel for insertion of trocars into which dissecting instruments are inserted to perform the
repair. Although this method has been shown to be relatively safe and efficient there are
reports of bowel and vascular injuries from the insertion of the smaller trocars which are
usually sharp. These can cause serious injuries.

Since 2009, a newer method of performing the key hole repair has been developed. This
involves placing a special single port under the navel via a 2-2.5cm incision and into which
3 blunt trocars are inserted. This negates the risks of injuries from sharp trocars. In
addition the fact that only a single incision is used this could potentially result in less
pain, reduced incidence of wound complications including infection and improved cosmetic
results.

However these potential advantages have not been proven in rigorous clinical studies as the
single port technique is still relatively new. It is hoped that this study will prove that
the single port technique is at least as effective and efficient as the conventional
technique in the cure of hernias and may have additional benefits as enumerated above.

Neither you nor your surgeon will know which procedure (three port or single port hernia
repair) until you are already asleep in the operating room and a random number selecting
process will automatically assign you to one procedure or the other. Sometimes it is not
possible to perform the single port safely in which case your procedure will be converted to
a three ports procedure.

All patients having surgical treatment of groin hernia at Holroyd Private Hospital are
subject to very careful assessment and study. All patients are requested to report
immediately if there are any problems. Any problems would normally be reported to your
treating surgeon who has primary responsibility for your care. Problems can be reported
directly to Holroyd Private Hospital. Any information in your medical records is subject to
stringent confidentiality requirements. The hospital is bound by the Australian Privacy
Council Charter as regards confidentiality and privacy.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01660048
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01660048