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Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00311935
Recruitment Status : Unknown
Verified February 2009 by Waitemata District Health Board.
Recruitment status was:  Recruiting
First Posted : April 6, 2006
Last Update Posted : February 3, 2009
Tyco Healthcare Group
Information provided by:
Waitemata District Health Board

Brief Summary:
This study will determine whether laparoscopic and open hernia repair have the same recurrence and complication rates in the under 60yr old age group. The overall financial costs of each repair will also be compared.

Condition or disease Intervention/treatment Phase
Hernia, Inguinal Procedure: method of hernia repair Not Applicable

Detailed Description:

Study population is Waitemata Health (Auckland New Zealand) patients presenting to clinic with unilateral primary inguinal hernia aged less than 60 years, fit for surgery and able to consent for the study. Randomized to open mesh repair or laparoscopic preperitoneal mesh repair. Two surgeons (Dr Rodgers and Dr Hammodat) using a standardized technique. Conversion rates from lap to open will be recorded.

Phone assessment postop day 1, 1 week and at 6 months. Clinic assessment at 4 weeks, 1 year and 2 years.

Primary outcome is hernia recurrence which will be assessed by a research nurse independent of surgeon at each clinic appointment. Assessment to also include assessment of ongoing symptoms such as pain/discomfort, sensory disturbance, and sexual dysfunction.

Quality of life assessment (SF 36 questionnaire) preoperatively and at each assessment.

Pain assessment 4hrs postop and at all other assessments by score 0-10 and measurement of pain relief.

Cost analysis to include the following parameters: theatre equipment costs, theatre time, drug use, hospital stay, time to return to work, time to return to normal activities.

Interim analysis at 2 years of followup by independent Health and Safety committee. Final analysis at 4 years of followup.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
Study Start Date : April 2006
Estimated Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Primary Outcome Measures :
  1. Hernia recurrence rates at 2 years post surgery.

Secondary Outcome Measures :
  1. Complication rates.
  2. Duration of procedure.
  3. Cost of equipment use.
  4. Rate of conversion to open procedure
  5. Length of hospital stay.
  6. Time to return to work and usual activities.
  7. Pain scores and analgesic use.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male <60yrs with primary inguinal hernia

Exclusion Criteria:

  • Recurrent hernia
  • Bilateral hernia
  • Non-reducible/obstructed hernia
  • Previous lower abdominal surgery/radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00311935

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Contact: Michael Rodgers, MBCHB, FRACS +64 9 486 8920 ext 3152
Contact: Hisham Hammodat, MBCHB, FRACS +64 9 486 8920 ext 2459

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New Zealand
Waitemata District Health Board Recruiting
Auckland, New Zealand
Sponsors and Collaborators
Waitemata District Health Board
Tyco Healthcare Group
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Principal Investigator: Michael Rodgers, MBCHB,FRACS Waitemata District Health Board
Layout table for additonal information Identifier: NCT00311935    
Other Study ID Numbers: Hernia repair study
First Posted: April 6, 2006    Key Record Dates
Last Update Posted: February 3, 2009
Last Verified: February 2009
Keywords provided by Waitemata District Health Board:
Abdominal wall
Additional relevant MeSH terms:
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Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal