- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01740882
Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks (ABSTACK)
Laparoscopic incisional hernia repair a variety of fixation methods has been proposed to ensure the correct and stable intra-abdominal placement of the mesh, in order to prevent recurrence, but on the other hand avoiding long-term pain and discomfort. The optimal method is unclear.
In Denmark the investigators have a nationwide database that records 80% of all ventral hernia repairs. The investigators combine data from the Danish Hernia Database, the National Patient Registry, and prospective questionnaire and clinical follow-up in order to get the true recurrence rate (clinical and reoperation rate) and the degree of long-term discomfort.
Purpose The purpose of this national prospective kohort study is to compare the risk of developing recurrence of incisional hernia after laparoscopic incisional hernia repair with either absorbable or non-absorbable tacks, and to investigate possible. late complaints in terms of pain and discomfort after the two mesh fixation devices.
The investigators include 355 laparoscopic incisional hernia repairs with absorbable tacks and 726 with non-absorbable tacks. It is expected that about 300 patients will be offered physical examination.
Material and Method Register-based cohort study of perioperative entry of patient data and prospective questionnaire follow-up and depending on the answer to any. clinical trial.
Follow-up is done by searching the Danish Hernia Database and the National Patient Register (to ensure data completeness) and distribution of patient questionnaire as reoperation for hernia recurrence is an underestimate of the true recurrence risk.
Statistics There will be performed frequency analyzes and Kaplan Meyer statistics on the 2 groups supplemented with multivariate Cox regression analysis. Using non-parametric statistics. P <0.05 considered statistically significant.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hvidovre, Denmark, 2650
- Hvidovre University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- laparoscopic incisional hernia repair with absorbable or non-absorbable tack mesh fixation.
- registered in the Danish Hernia Database
- willing to participate in the study and complete the questionnaire
Exclusion Criteria:
- lost to follow-up
- emigration
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recurrence
Time Frame: follow-up time up to 4 years
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reoperation for recurrence and clinical recurrence
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follow-up time up to 4 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic pain
Time Frame: Follow-up time up to 4 years
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Degree of pain and/or discomfort in the area of incision
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Follow-up time up to 4 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mette W Christoffersen, M.D., Hvidovre University Hospital
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABSTACK-123
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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