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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]

SILTelescopic

Universal Trial Number (UTN)

Trial acronym

SILTelescopic

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Inguinal Hernia

Condition category

Condition code

Oral and Gastrointestinal

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]

Post-op pain

Timepoint [1]

measured on day 1 and day 7

Secondary outcome [1]

• Conversion to multiport or open operation

Timepoint [1]

up to one year

Secondary outcome [2]

• Length of hospital stay

Timepoint [2]

up to one year

Secondary outcome [3]

operation time

Timepoint [3]

participants will be followed for the duration of hospital stay, an expected average of 1 day

Secondary outcome [4]

Analgesic requirements

Timepoint [4]

up to one week

Secondary outcome [5]

return to work or normal physical activities

Timepoint [5]

up to one year

Secondary outcome [6]

Quality of life health scores

Timepoint [6]

up to 1 year

Secondary outcome [7]

Cosmetic scar score

Timepoint [7]

1 year

Secondary outcome [8]

Recurrence of hernia

Timepoint [8]

1 year

Secondary outcome [9]

post-operative complications including urinary retention, wound infection, seroma formation, chronic pain, testicular atrophy

Timepoint [9]

1 year

Secondary outcome [10]

cost analysis of the ports used

Timepoint [10]

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?

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]

Holroyd Private Hospital - Guildford

Recruitment hospital [2]

St Luke's Hospital - Potts Point

Recruitment postcode(s) [1]

2161 - Guildford

Recruitment postcode(s) [2]

2011 - Potts Point

Funding & Sponsors

Primary sponsor type

Other

Name

The Sydney Hernia Specialists Clinic

Address

Country

Other collaborator category [1]

Other

Name [1]

University of Sydney

Address [1]

Country [1]

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

Wayne J Hawthorne, MD

Address

The Unviversity of Sydney

Country

Phone

Fax

Contact person for public queries

Name

Hanh M Tran, FRACS

Address

Country

Phone

61 2 9221 1043

Fax

[email protected]

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

Type	Citations or Other Details
Journal	Tran H. Safety and efficacy of single incision lap... [More Details]
Journal	Tran H. Robotic single-port hernia surgery. JSLS. ... [More Details]
Journal	Tran H. Safety and efficacy of laparoendoscopic si... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT01883115

Trial Review

Registering a new trial?

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