A Prospective Study Comparing Single and Multiport Laparoscopic Inguinal Hernia Repair (SILSTEP)

This study has been completed.
Sponsor:
Collaborator:
University of Sydney
Information provided by (Responsible Party):
Dr Hanh Minh Tran, The Sydney Hernia Specialists Clinic
ClinicalTrials.gov Identifier:
NCT01660048
First received: July 31, 2012
Last updated: March 18, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Inguinal Hernia
Procedure: SILS TEP repair
Procedure: Total extraperitoneal inguinal hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Randomized Single Blind Controlled Study Comparing Single and Multiport Laparoscopic Total Extraperitoneal Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by The Sydney Hernia Specialists Clinic:

Primary Outcome Measures:
  • Conversion to multiport or open operation [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Operating time [ Time Frame: during operation ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    SF36 forms are completed before operation, 6 weeks and 1 year after operation

  • Cosmetic scar score [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
    patients will be asked to assess satisfaction of their own scars 6 weeks after surgery

  • Recurrence of hernia [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    Patients will be seen at 1 week, 6 weeks to assess for any peri-operative complications associated with hernia surgery as enumerated above


Enrollment: 100
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SILS TEP repair
Half of the patients will undergo laparoscopic total extraperitoneal inguinal hernia repair using a single port (Triport)
Procedure: SILS TEP repair
perform the laparoscopic total extraperitoneal inguinal hernia repair using a single port
Other Name: single port inguinal hernia repair
Procedure: Total extraperitoneal inguinal hernia repair
Conventional multiport laparoscopic total extraperitoneal inguinal hernia repair
Other Name: Laparoscopic TEP inguinal hernia repair
Active Comparator: Multiports TEP repair
Half of the patients will undergo the conventional multiports total extraperitoneal inguinal hernia repair
Procedure: Total extraperitoneal inguinal hernia repair
Conventional multiport laparoscopic total extraperitoneal inguinal hernia repair
Other Name: Laparoscopic TEP inguinal hernia repair

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 86 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • all referred patients with inguinal hernias

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01660048

Locations
Australia, New South Wales
Holroyd Private Hospital
Guildford, New South Wales, Australia, 2000
Sponsors and Collaborators
The Sydney Hernia Specialists Clinic
University of Sydney
Investigators
Principal Investigator: Hanh M Tran, MD, FRACS Sydney Hernia Specialists Clinic
  More Information

Additional Information:
Publications:
Responsible Party: Dr Hanh Minh Tran, Director, The Sydney Hernia Specialists Clinic
ClinicalTrials.gov Identifier: NCT01660048     History of Changes
Other Study ID Numbers: HTranSILStrial, Holroyd Private Hospital
Study First Received: July 31, 2012
Last Updated: March 18, 2013
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by The Sydney Hernia Specialists Clinic:
Laparoscopic total extraperitoneal Inguinal hernia repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 29, 2014