Hernia, InguinalNCT00311935
Laparoscopic vs Open Hernia Mesh Repair for Inguinal Hernia
A study testing method of hernia repair in people with Hernia, Inguinal, run by Waitemata District Health Board at 1 site in New Zealand.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 60 years, men only
- Conditions the study is for
- Hernia, Inguinal
- What is being tested?
- method of hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 350 participants
- Where
- 1 siteNew Zealand
- Study dates
- Apr 2006to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male <60yrs with primary inguinal hernia
Who cannot join
- Recurrent hernia
- Bilateral hernia
- Non-reducible/obstructed hernia
- Previous lower abdominal surgery/radiotherapy
Trial locations and contacts
1 site in 1 country.
New Zealand1 site, 1 recruiting
- Recruiting
Waitemata District Health Board
Auckland
About this study
Official title: Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
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.
Read the 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.
- Conditions
- Hernia, Inguinal
- Being tested
- method of hernia repair
- Keywords
- Hernia, Inguinal, Groin, Laparoscopic, Open, Abdominal wall
- Medical subject headings
- Hernia, Inguinal, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
method of hernia repairProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Hernia recurrence rates at 2 years post surgery.
Secondary outcomes (7)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2006 (estimated)
- Study startApr 2006
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Waitemata District Health Board
- Sponsor type
- Other government
- Collaborators
- Tyco Healthcare Group
- Investigators
- Michael Rodgers, MBCHB,FRACS, Principal investigator, Waitemata District Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311935
- Sponsor's protocol ID
- Hernia repair study
- Status last verified
- Feb 2009
- First submitted
- 5 Apr 2006
- Last updated
- 3 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Laparoscopic vs. Open Mesh Inguinal Hernia Repair in Men Under the Age of 60
- ClinicalTrials.gov ID
- NCT00311935
- Acronym / sponsor ID
- Hernia repair study
- Conditions
- Hernia, Inguinal
- Keywords
- Hernia, Inguinal, Groin, Laparoscopic, Open, Abdominal wall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Waitemata District Health BoardOther government
- Collaborators
- Tyco Healthcare Group
- Study start
- Apr 2006
- Study completion
- May 2010 (estimated)
- First posted
- 6 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 15 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Male <60yrs with primary inguinal hernia
Key exclusion criteria (4 listed)
- Recurrent hernia
- Bilateral hernia
- Non-reducible/obstructed hernia
- Previous lower abdominal surgery/radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| method of hernia repair | Procedure or surgery | – |
Primary outcome
Hernia recurrence rates at 2 years post surgery.
7 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Rodgers, MBCHB,FRACS principal investigator
Waitemata District Health Board
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing method of hernia repair in people with Hernia, Inguinal, run by Waitemata District Health Board at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Rodgers, MBCHB, FRACS (+64 9 486 8920 ext. 3152, michael.rodgers@waitematadhb.govt.nz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hernia recurrence rates at 2 years post surgery.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2009.