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Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Waitemata District Health Board.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Tyco Healthcare Group
Information provided by:
Waitemata District Health Board
ClinicalTrials.gov Identifier:
NCT00311935
First received: April 5, 2006
Last updated: February 2, 2009
Last verified: February 2009
  Purpose

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 Intervention
Hernia, Inguinal
Procedure: method of hernia repair

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Waitemata District Health Board:

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

Secondary Outcome Measures:
  • Complication rates.
  • Duration of procedure.
  • Cost of equipment use.
  • Rate of conversion to open procedure
  • Length of hospital stay.
  • Time to return to work and usual activities.
  • Pain scores and analgesic use.

Estimated Enrollment: 350
Study Start Date: April 2006
Estimated Study Completion Date: May 2010
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.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male <60yrs with primary inguinal hernia

Exclusion Criteria:

  • Recurrent hernia
  • Bilateral hernia
  • Non-reducible/obstructed hernia
  • Previous lower abdominal surgery/radiotherapy
  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: NCT00311935

Contacts
Contact: Michael Rodgers, MBCHB, FRACS +64 9 486 8920 ext 3152 michael.rodgers@waitematadhb.govt.nz
Contact: Hisham Hammodat, MBCHB, FRACS +64 9 486 8920 ext 2459 hisham.hammodat@waitematadhb.govt.nz

Locations
New Zealand
Waitemata District Health Board Recruiting
Auckland, New Zealand
Sponsors and Collaborators
Waitemata District Health Board
Tyco Healthcare Group
Investigators
Principal Investigator: Michael Rodgers, MBCHB,FRACS Waitemata District Health Board
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00311935     History of Changes
Other Study ID Numbers: Hernia repair study
Study First Received: April 5, 2006
Last Updated: February 2, 2009
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Waitemata District Health Board:
Hernia
Inguinal
Groin
Laparoscopic
Open
Abdominal wall

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

ClinicalTrials.gov processed this record on November 25, 2014