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

This study will compare the extraperitoneal dissection during single-port laparoscopic total extraperitoneal repair of inguinal/femoral hernias using the traditional balloon dissection and the telescopic dissection techniques.

Laparoscopic hernia repair was first introduced in 1990. The uptake rate was slow to start off with such that in 1994 only 9.7% of all inguinal hernias were performed laparoscopically However, in 2012, the figure now stands at 48% Australia-wide. (www.medicareaustralia.gov.au). Indeed, in the State of New South Wales this figure stands at 51%, which means that it is the commonest operation performed for inguinal hernias in this State.

Up to 2009, the laparoscopic hernia repair involves the insertion of 3 ports: 10mm port in the infra-umbilical region for the camera via a 2 cm incision and 2 x 5 mm working ports usually in the midline for the dissecting instruments via 2 x 10 mm incisions. These ports are called secondary trocars which are usually sharp. Their insertion has the potential to cause bowel and vascular injuries.

The European Hernia Society guidelines (www.herniaweb.org) on the treatment of inguinal hernias have shown (conventional) endoscopic techniques to be associated with higher rates of port-site hernias and visceral injuries especially during the learning curve period.

A recent study of 37,000 gynaecological laparoscopies in the US showed a bowel injury rate of 0.16%; a third of these led to the death of the patients. 22% of all bowel injuries resulted from the insertion of secondary trocars (www.danaise.com/vascular_and_bowel_injuries_duri.htm).

Another report from a large hernia centre in the US showed that in the first 300 transabdominal preperitoneal (TAPP) repairs 2 bowel injuries (and one bladder injury) were observed. Indeed, when these investigators changed the technique to a TEP repair they also observed 2 bowel injuries (and one bladder injury) in the first 300 TEP repairs. (www.ncbi.nlm.nih.gov/pubmed/11178763) Therefore bowel and vascular injuries during laparoscopic surgery are real but they are often under reported.

Single incision laparoscopic surgery, where all the instruments are placed in a single port, has the primary aim of preventing vascular and bowel injury through the use of completely blunt trocars as in the case of the SILS™ port. The first case of laparoscopic TEP repair was reported in 2009. Since then there have numerous reports confirming the safety and efficacy of the single-port technique.

The principle author, Dr Hanh Tran, has been performing single incision laparoscopic hernia repair since October 2009. To date, he has performed in excess of 600 cases with excellent results and this was confirmed in a recently completed prospective randomized controlled study comparing single-port vs. multiport laparoscopic inguinal herniorraphy (NCT 01660048) in achieving successful cure of hernias, no complications including wound infection, reduced post-op pain/analgesic requirements, earlier return to work/physical activities, high patient satisfaction and excellent cosmetic results.

However this was achieved at significant additional costs because of the use of the single ports. These costs were not reimbursed by the medical insurance companies. The single-port technique allows for direct insertion of the dissecting instruments into the extraperitoneal space where complete dissection can occur under direct vision as supposed to blind dissection with the balloon dissector just so that two 5mm ports can be inserted during multiport TEP repair.

It is proposed that 51 (or more) patients will be enrolled into the study and this will be compared to the previous 51 patients in the previous RCT with balloon dissection. The single-port TEP inguinal herniorraphy is exactly the same in both procedures except in the telescopic technique the dissection of the extraperitoneal dissection is done under direct vision without the use of the balloon dissector.

The main disadvantage of the single port technique is the relative loss of triangulation and the principle author has shown that this can be overcome with the use of a longer and smaller laparoscope (of which Holroyd Private Hospital has bought two specifically for this purpose), different dissecting techniques and with increased experience. Therefore, if a surgeon is not experienced with this technique the operation and its success can be compromised by inadequate dissection. The author (who has performed over 2500 TEP repairs over the past 13 years) believes that the learning curve for single-port TEP hernia repair for a highly experienced TEP surgeon is around 25-50 ie after this number the operation time will approach that of the standard three ports TEP repair and this has been shown in our recently completed RCT. He has performed in excess of 600 Single-port Laparoscopic hernia repairs since October 2009. Therefore the success of the operation for patients in either arm of the study will not be compromised by lack of experience.

The follow up of these patients will be no different to those followed up under the protocol of the Sydney Hernia Specialists/Clinic. This is a standard follow up and is consistent with normal clinical practice.

In summary, the goals are simple. (i) To perform single-port laparoscopic TEP inguinal herniorraphy with telescopic extraperitoneal dissection; (ii) To assess the efficacy of the newer telescopic dissection technique in a rigorous scientific manner; (iii) To report any unexpected problems or complications; (iv) To follow up patients treated laparoscopically to ensure that the single-port technique with balloon dissection or telescopic dissection have as good results as or better in terms of cure of hernia (absence of recurrence of the hernia) and less complications and better cosmetic results as that which is achieved when the traditional 3-ports technique is used and; (v) to assess the outcomes of patients undergoing telescopic dissection vs. balloon dissection.