A Prospective Study Comparing Single and Multiport Laparoscopic Inguinal Hernia Repair

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.

Conditions

• Inguinal Hernia

Interventions

PROCEDURE

SILS TEP repair

perform the laparoscopic total extraperitoneal inguinal hernia repair using a single port

PROCEDURE

Total extraperitoneal inguinal hernia repair

Conventional multiport laparoscopic total extraperitoneal inguinal hernia repair

Sponsors & Collaborators

• University of Sydney

  collaborator OTHER

• The Sydney Hernia Specialists Clinic

  lead OTHER

Principal Investigators

• Hanh M Tran, MD, FRACS · Sydney Hernia Specialists Clinic

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Max Age

86 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-12-31

Primary Completion

2013-01-31

Completion

2013-03-31

Countries

• Australia

Study Locations