A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC)

NCT01883115 | Unknown DMC

• 1 other identifier: SILTelescopic
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 2

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symphysis, and the camera itself, if used as dissection device, would become smudged and it would have to be repeatedly withdrawn for cleaning.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.

Conditions

Inguinal Hernia

Keywords

Telescopic extraperitoneal dissection; Single incision laparosocpic surgery; Inguinal hernia; Triport system

Outcome Measures

Primary Outcomes (1)

• Post-op pain

  Post-op pain measured on day 1 and 7 using the visual analogue score of 0 to 10

  measured on day 1 and day 7

Secondary Outcomes (10)

• • Conversion to multiport or open operation

  up to one year

• • Length of hospital stay

  up to one year

• operation time

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

• Analgesic requirements

  up to one week

• return to work or normal physical activities

  up to one year

Study Arms (1)

Telescopic group

All eligible patients referred with inguinal/femoral hernias will be enrolled into the study from February 2013

Eligibility Criteria

• Age: 16 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All eligible patients referred with inguinal/femoral hernias from February 2013 will be enrolled into the study

You may qualify if:

• \- all patients referred with inguinal/femoral hernias

You may not qualify if:

• workers Compensation cases
• previous extraperitoneal intervention
• unfit for a general anaesthetic
• strangulated hernias

Sponsors & Collaborators

• The Sydney Hernia Specialists Clinic: lead
• University of Sydney: collaborator

Study Sites (2)

Holroyd Private Hospital

Guildford, New South Wales, 2161, Australia

RECRUITING

St Luke's Hospital

Potts Point, New South Wales, 2011, Australia

RECRUITING

Related Publications (4)

• 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.

  PMID: 21902942 RESULT

• Tran H. Robotic single-port hernia surgery. JSLS. 2011 Jul-Sep;15(3):309-14. doi: 10.4293/108680811X13125733356198.

  PMID: 21985715 RESULT

• 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.

  PMID: 23477172 RESULT

• 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.

  PMID: 25644488 DERIVED

Related Links

• Sydney Hernia Specialists Clinic

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Wayne J Hawthorne, MD

  The Unviversity of Sydney

  STUDY CHAIR

Central Study Contacts

Hanh M Tran, FRACS

CONTACT

61 2 9221 1043; drhmtran@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: June 16, 2013
• First Posted: June 21, 2013
• Study Start: February 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2015
• Last Updated: April 4, 2014

Record last verified: 2014-04

Locations

AU (2)