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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01883115




Registration number
NCT01883115
Ethics application status
Date submitted
16/06/2013
Date registered
21/06/2013
Date last updated
4/04/2014

Titles & IDs
Public title
A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC)
Scientific title
A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC)
Secondary ID [1] 0 0
SILTelescopic
Universal Trial Number (UTN)
Trial acronym
SILTelescopic
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
Observational [Patient Registry]
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Telescopic group - All eligible patients referred with inguinal/femoral hernias will be enrolled into the study from February 2013
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Post-op pain
Timepoint [1] 0 0
measured on day 1 and day 7
Secondary outcome [1] 0 0
• Conversion to multiport or open operation
Timepoint [1] 0 0
up to one year
Secondary outcome [2] 0 0
• Length of hospital stay
Timepoint [2] 0 0
up to one year
Secondary outcome [3] 0 0
operation time
Timepoint [3] 0 0
participants will be followed for the duration of hospital stay, an expected average of 1 day
Secondary outcome [4] 0 0
Analgesic requirements
Timepoint [4] 0 0
up to one week
Secondary outcome [5] 0 0
return to work or normal physical activities
Timepoint [5] 0 0
up to one year
Secondary outcome [6] 0 0
Quality of life health scores
Timepoint [6] 0 0
up to 1 year
Secondary outcome [7] 0 0
Cosmetic scar score
Timepoint [7] 0 0
1 year
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
1 year
Secondary outcome [10] 0 0
cost analysis of the ports used
Timepoint [10] 0 0
up to one year

Eligibility
Key inclusion criteria
- all patients referred with inguinal/femoral 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

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2015
Actual
Sample size
Target
102
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Holroyd Private Hospital - Guildford
Recruitment hospital [2] 0 0
St Luke's Hospital - Potts Point
Recruitment postcode(s) [1] 0 0
2161 - Guildford
Recruitment postcode(s) [2] 0 0
2011 - Potts Point

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
Our recent prospective randomized controlled study comparing single-port vs. multiport laparoscopic total extraperitoneal inguinal herniorraphy (NCT 01660048) demonstrated superiority of the single-port technique in reducing post-op pain/analgesic requirements, quicker return to work/normal physical activities and improved cosmetic scar scores. During this study all patients underwent the initial extraperitoneal dissection with the distension balloon. However, the balloon itself costs AU $380 per device which represents a significant percentage of the overall cost of the procedure (when the hospital/operating rooms cost is approximately AU $2500 for a unilateral laparoscopic inguinal hernia repair) especially if only unilateral inguinal herniorraphy is performed.

The European Hernia Society Guidelines encourage the use of the distension balloon for the initial distension/dissection of the extraperitoneal space especially during the learning curve. This recommendation arises from the fact that during the conventional multiport repair the umbilical port allows only the insertion of the laparoscope and the extraperitoneal space cannot easily be dissected with the scope itself, especially in patients with well-developed linea alba extending down to the pubic symphysis, and the camera itself, if used as dissection device, would become smudged and it would have to be repeatedly withdrawn for cleaning. Yet this must occur since the extraperitoneal space must be dissected in the midline sufficiently for safe insertion of two additional 5 mm ports for insertion of dissecting instruments in order to complete the extraperitoneal space dissection and the repair.

With single incision laparoscopic surgery the use of the Triport™ system ensure that the port can be place under direct vision into the extraperitoneal space when the scope and two dissecting instruments can be safely inserted at the outset. In this way the extraperitoneal space can be dissected under direct vision. The balloon dissection is essentially a blind dissection even though the balloon distension is being observed by the scope, incorrect tissue planes can be entered ie the dissection can occur below the pre-peritoneal fascia exposing the nerves in the groin with the potential risks for nerve damage and entrapment. This is an argument that surgeons who practise transabdominal preperitoneal inguinal hernia repair use to justify their superior technique over the TEP repair because, in the TAPP repair, the peritoneum is carefully dissected free from and leaving the underlying preperitoneal fascia intact.

While the use of the balloon, when some 25 "pumps" of air are used during the insufflation, to create a significant space to place not only the two 5 mm ports but also to create a significant extraperitoneal dissection when usually only the lateral space and the hernia sac need to be dissected this is not always possible. In patients who have had previous lower abdominal surgery including previous anterior inguinal herniorraphy (especially if the mesh plug is used) the balloon dissention is normally judicious as one cannot predict whether there are any significant peritoneal or even bowel adhesions. Consequently, in such cases, the balloon distension is normally confined to an area just inferior to the umbilical port and superior to the pubic symphysis so that there is just enough extraperitoneal dissection to place the two 5 mm trocars. Usually this means only using only 5 pumps of air in the distension balloon for placement of two 5 mm trocars. Then the dissection of the extraperitonealy space under direct vision can take place. The use of the distension balloon in such cases represents an enormous waste of resources since AU $380 is spent just to create enough space to place the two 5 mm ports and hence allowing the insertion of the dissecting instruments. With the Triport+™ port the dissecting instruments can easily be placed in the extraperitoneal space and the dissection can begin under direct vision hence achieving the same safe dissection that TAPP surgeons claim to perform.

In this study we aim to look at the safety and efficacy of telescopic vs. balloon dissection by prospectively comparing a similar former group of patients to the ones who had previously undergone single-port inguinal herniorraphy with balloon dissection in our previous study (NCT 01660048).

All patients having surgical treatment of groin hernia at St Luke's and Holroyd Private Hospitals are subject to very careful assessment and study. All patients are requested to report immediately if there are any problems.
Trial website
https://clinicaltrials.gov/study/NCT01883115
Trial related presentations / publications
Tran H. Safety and efficacy of single incision laparoscopic surgery for total extraperitoneal inguinal hernia repair. JSLS. 2011 Jan-Mar;15(1):47-52. doi: 10.4293/108680811X13022985131174.
Tran H. Robotic single-port hernia surgery. JSLS. 2011 Jul-Sep;15(3):309-14. doi: 10.4293/108680811X13125733356198.
Tran H. Safety and efficacy of laparoendoscopic single-site surgery for abdominal wall hernias. JSLS. 2012 Apr-Jun;16(2):242-9. doi: 10.4293/108680812x13427982376301.
Tran H, Tran K, Turingan I, Zajkowska M, Lam V, Hawthorne W. Single-incision laparoscopic inguinal herniorraphy with telescopic extraperitoneal dissection: technical aspects and potential benefits. Hernia. 2015 Jun;19(3):407-16. doi: 10.1007/s10029-015-1349-6. Epub 2015 Feb 3.
Public notes

Contacts
Principal investigator
Name 0 0
Wayne J Hawthorne, MD
Address 0 0
The Unviversity of Sydney
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Hanh M Tran, FRACS
Address 0 0
Country 0 0
Phone 0 0
61 2 9221 1043
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/study/NCT01883115