Incisional Hernia Clinical Trial
— ABSTACKOfficial title:
Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks
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.
Status | Completed |
Enrollment | 816 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Denmark | Hvidovre University Hospital | Hvidovre |
Lead Sponsor | Collaborator |
---|---|
Hvidovre University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence | reoperation for recurrence and clinical recurrence | follow-up time up to 4 years | No |
Secondary | Chronic pain | Degree of pain and/or discomfort in the area of incision | Follow-up time up to 4 years | No |
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