A Prospective Study Comparing Single and Multiport Laparoscopic Inguinal Hernia Repair
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional

Summary: 
      Since laparoscopic inguinal hernia was introduced in 1990, it has now become the most
      commonly performed hernia repair in NSW. Traditionally this is done with 3 small incisions: a
      2 cm incision under the navel for insertion of the camera and two 1 cm incisions below the
      navel for insertion of trocars into which dissecting instruments are inserted to perform the
      repair. Although this method has been shown to be relatively safe and efficient there are
      reports of bowel and vascular injuries from the insertion of the smaller trocars which are
      usually sharp. These can cause serious injuries.

      Since 2009, a newer method of performing the key hole repair has been developed. This
      involves placing a special single port under the navel via a 2-2.5cm incision and into which
      3 blunt trocars are inserted. This negates the risks of injuries from sharp trocars. In
      addition the fact that only a single incision is used this could potentially result in less
      pain, reduced incidence of wound complications including infection and improved cosmetic
      results.

      However these potential advantages have not been proven in rigorous clinical studies as the
      single port technique is still relatively new. It is hoped that this study will prove that
      the single port technique is at least as effective and efficient as the conventional
      technique in the cure of hernias and may have additional benefits as enumerated above.

      Neither you nor your surgeon will know which procedure (three port or single port hernia
      repair) until you are already asleep in the operating room and a random number selecting
      process will automatically assign you to one procedure or the other. Sometimes it is not
      possible to perform the single port safely in which case your procedure will be converted to
      a three ports procedure.

      All patients having surgical treatment of groin hernia at Holroyd Private Hospital are
      subject to very careful assessment and study. All patients are requested to report
      immediately if there are any problems. Any problems would normally be reported to your
      treating surgeon who has primary responsibility for your care. Problems can be reported
      directly to Holroyd Private Hospital. Any information in your medical records is subject to
      stringent confidentiality requirements. The hospital is bound by the Australian Privacy
      Council Charter as regards confidentiality and privacy.
    

Detailed description: 
      This study will compare the Laparoscopic TEP repair of inguinal/femoral hernias using the
      traditional three ports and the newer single port 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 2009, the figure now stands at 40% Australia-wide.
      (www.medicareaustralia.gov.au). Indeed, in NSW this figure stands at 48%, 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 5mm working ports
      usually in the midline for the dissecting instruments via 2 x 10mm 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. The first case of laparoscopic TEP repair was reported in 2009. Since then
      there have only been a handful of reports.

      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 100 cases with excellent
      results in terms of success of the cure of hernias (no recurrence has been observed in any of
      these patients although the follow-up has only been up to 1 year), no complications including
      wound infection, high patient satisfaction and excellent cosmetic results.

      However Dr Tran's experience is at best an audit. The highest level of scientific evidence
      regarding the efficacy and safety of one procedure versus another comes from a prospective
      randomised controlled study where two procedures are compared and the patients (with their
      informed consent) will undergo either procedure in a random (blind) fashion.

      It is proposed that 100 patients will be enrolled into the study with 50 patients in each arm
      of the study ie 50 patients will undergo TEP repair using the conventional three ports and 50
      with the single port technique.

      The TEP inguinal hernia repair is exactly the same in both procedures except in the single
      port technique only one (1.5-2cm) infra-umbilical incision is required. While the first 100
      cases were performed with the SILS (TM) port this required a relatively larger infraumbilical
      incision. The availability of the Triport (TM) allows an equally small if not smaller
      infraumbilical incision and this would be suited to all patients rather than those with a
      naturally large umbilicus. Over 180 TEP inguinal hernia repairs were performed with the
      Triport before the commencement of the trial to ensure that the learning curve has been truly
      passed. Therefore the use of the Triport allows for just one inconspicuous incision compared
      to three incisions for the conventional multiport inguinal hernia repair with possible
      improved cosmetic results.

      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 nearly 2000 TEP repairs over the past 10
      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. He has performed in excess of 100 Single Port
      Incision Laparoscopic hernia repairs over the past year. 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 Clinic. This is a standard follow up and is consistent with normal
      clinical practice.

      In summary, the goals are simple. (i) To perform laparoscopic TEP inguinal hernia repair
      using either the conventional three ports or single port technique; (ii) To assess the
      efficacy of the newer single port 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 has 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.
    

Intervention name(s): SILS TEP repair; Total extraperitoneal inguinal hernia repair
Intervention type(s): Procedure; Procedure
Intervention description(s): perform the laparoscopic total extraperitoneal inguinal hernia repair using a single port; Conventional multiport laparoscopic total extraperitoneal inguinal hernia repair
Other intervention name(s): single port inguinal hernia repair; Laparoscopic TEP inguinal hernia repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Laparoscopic total extraperitoneal Inguinal hernia repair