Clinical Trial: A Prospective Study Comparing Single and Multiport Laparoscopic Inguinal Hernia Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Prospective Randomized Single Blind Controlled Study Comparing Single and Multiport Laparoscopic Total Extraperitoneal Inguinal Hernia Repair

Brief 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.

Detailed Summary:

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, whe
Sponsor: The Sydney Hernia Specialists Clinic

Current Primary Outcome: Conversion to multiport or open operation [ Time Frame: during operation ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Operating time [ Time Frame: during operation ]
  This assess the time taken to perform the operation and is defined as time from initial skin incision to complete wound closure
• Length of hospital stay [ Time Frame: day procedure or overnight stay ]
  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
• Pre and post operative pain scores [ Time Frame: preop, day one and day 7 postop ]
  This utilizes the visual analogue pain score 0-10 and the patients are assessed preoperatively, day 1 and day 7 after surgery
• Analgesic requirements [ Time Frame: 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: 6 weeks ]
  This assesses how soon patients return to work or normal physical activities
• Quality of life health scores [ Time Frame: preop, 6 weeks and 1 year postop ]
  SF36 forms are completed before operation, 6 weeks and 1 year after operation
• Cosmetic scar score [ Time Frame: 6 weeks ]
  patients will be asked to assess satisfaction of their own scars 6 weeks 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: 6 weeks ]
  Patients will be seen at 1 week, 6 weeks to assess for any peri-operative complications associated with hernia surgery as enumerated above

Original Secondary Outcome: Same as current

Information By: The Sydney Hernia Specialists Clinic

Dates:
Date Received: July 31, 2012
Date Started: December 2011
Date Completion:
Last Updated: March 18, 2013
Last Verified: March 2013