A Prospective Study Comparing Single and Multiport Laparoscopic Inguinal Hernia Repair

NCT01660048 | Completed DMC

• 2 other identifiers: HTranSILStrialHolroyd Private Hospital
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 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

Keywords

Laparoscopic total extraperitoneal Inguinal hernia repair

Outcome Measures

Primary Outcomes (1)

• Conversion to multiport or open operation

  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.

  during operation

Secondary Outcomes (9)

• Operating time

  during operation

• Length of hospital stay

  day procedure or overnight stay

• Pre and post operative pain scores

  preop, day one and day 7 postop

• Analgesic requirements

  one week

• return to work or normal physical activities

  6 weeks

Study Arms (2)

SILS TEP repair

EXPERIMENTAL

Half of the patients will undergo laparoscopic total extraperitoneal inguinal hernia repair using a single port (Triport)

Procedure: SILS TEP repair; Procedure: Total extraperitoneal inguinal hernia repair

Multiports TEP repair

ACTIVE COMPARATOR

Half of the patients will undergo the conventional multiports total extraperitoneal inguinal hernia repair

Procedure: Total extraperitoneal inguinal hernia repair

Interventions

SILS TEP repair PROCEDURE

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

Also known as: single port inguinal hernia repair

SILS TEP repair

Total extraperitoneal inguinal hernia repair PROCEDURE

Conventional multiport laparoscopic total extraperitoneal inguinal hernia repair

Also known as: Laparoscopic TEP inguinal hernia repair

Multiports TEP repair; SILS TEP repair

Eligibility Criteria

• Age: 16 Years - 86 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• all referred patients with inguinal hernias

You may not qualify if:

• workers Compensation cases
• previous extraperitoneal intervention
• unfit for a general anaesthetic
• strangulated hernias
• present of or previous ventral hernia repair extending 5 cm below umbilicus

Sponsors & Collaborators

• The Sydney Hernia Specialists Clinic: lead
• University of Sydney: collaborator

Study Sites (1)

Holroyd Private Hospital

Guildford, New South Wales, 2000, Australia

Location

Related Publications (3)

• Tran H. Robotic single-port hernia surgery. JSLS. 2011 Jul-Sep;15(3):309-14. doi: 10.4293/108680811X13125733356198.

  PMID: 21985715 RESULT

• Tran H. Safety and efficacy of single incision laparoscopic surgery for total extraperitoneal inguinal hernia repair. JSLS. 2011 Jan-Mar;15(1):47-52. doi: 10.4293/108680811X13022985131174.

  PMID: 21902942 RESULT

• Tran H, Tran K, Turingan I, Zajkowska M, Lam V, Hawthorne W. Single-incision laparoscopic inguinal herniorraphy with telescopic extraperitoneal dissection: technical aspects and potential benefits. Hernia. 2015 Jun;19(3):407-16. doi: 10.1007/s10029-015-1349-6. Epub 2015 Feb 3.

  PMID: 25644488 DERIVED

Related Links

• The Sydney Hernia Clinic
• The Sydney Hernia Specialists Clinic
• The University of Sydney

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Hanh M Tran, MD, FRACS

  Sydney Hernia Specialists Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: July 31, 2012
• First Posted: August 8, 2012
• Study Start: December 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 20, 2013

Record last verified: 2013-03

Locations

AU (1)