A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC) (SILTelescopic)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01883115|
Recruitment Status : Unknown
Verified April 2014 by Dr Hanh Minh Tran, The Sydney Hernia Specialists Clinic.
Recruitment status was: Recruiting
First Posted : June 21, 2013
Last Update Posted : April 4, 2014
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symphysis, and the camera itself, if used as dissection device, would become smudged and it would have to be repeatedly withdrawn for cleaning.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.
|Condition or disease|
Show Detailed Description
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||102 participants|
|Target Follow-Up Duration:||12 Months|
|Official Title:||A Prospective Study Comparing Telescopic vs. Balloon Dissection in Single Incision Laparoscopic Inguinal Herniorraphy (SILTELESCOPIC)|
|Study Start Date :||February 2013|
|Estimated Primary Completion Date :||April 2014|
|Estimated Study Completion Date :||April 2015|
All eligible patients referred with inguinal/femoral hernias will be enrolled into the study from February 2013
- Post-op pain [ Time Frame: measured on day 1 and day 7 ]Post-op pain measured on day 1 and 7 using the visual analogue score of 0 to 10
- • Conversion to multiport or open operation [ Time Frame: up to one year ]This refers to whether any single port procedure needs to be converted to multiports or open procedure. This is quite a normal process as a proportion of multiport procedures are converted to open procedures for safety reasons.
- • Length of hospital stay [ Time Frame: up to one year ]This assess how long patient stays in hospital whether it is a day procedure or whether they need to stay in hospital overnight or longer
- operation time [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 1 day ]this is measured from initial skin incision to complete wound closure
- Analgesic requirements [ Time Frame: up to one week ]This assesses how many painkiller tablets (Dextropropoxyphene) patients ingest in the first week after operation
- return to work or normal physical activities [ Time Frame: up to one year ]This assesses how soon patients return to work or normal physical activities
- Quality of life health scores [ Time Frame: up to 1 year ]SF36 forms are completed before operation, 6 weeks and 1 year after operation
- Cosmetic scar score [ Time Frame: 1 year ]Scar length will be measured at 6 weeks postop and patients will be asked to assess satisfaction of their own scars 6 weeks and 1 year after surgery
- Recurrence of hernia [ Time Frame: 1 year ]Patients will be assessed at 1 week, 6 weeks and one year to detect presence of recurrence of hernia
- post-operative complications including urinary retention, wound infection, seroma formation, chronic pain, testicular atrophy [ Time Frame: 1 year ]Patients will be seen at 1 week, 6 weeks to assess for any peri-operative complications associated with hernia surgery as enumerated above
- cost analysis of the ports used [ Time Frame: up to one year ]Cost savings arising from telescopic dissection will be assessed using data provided by the Hospital Finance Department regarding the costs of the single ports
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883115
|Contact: Hanh M Tran, FRACS||61 2 9221 firstname.lastname@example.org|
|Australia, New South Wales|
|Holroyd Private Hospital||Recruiting|
|Guildford, New South Wales, Australia, 2161|
|Contact: Hanh M Tran, FRACS 61 2 9221 1043 email@example.com|
|St Luke's Hospital||Recruiting|
|Potts Point, New South Wales, Australia, 2011|
|Contact: Hanh M Tran, FRACS 61 2 9221 1043 firstname.lastname@example.org|
|Study Chair:||Wayne J Hawthorne, MD||The Unviversity of Sydney|