Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks (ABSTACK)
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|ClinicalTrials.gov Identifier: NCT01740882|
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : April 25, 2014
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||816 participants|
|Official Title:||Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
- Recurrence [ Time Frame: follow-up time up to 4 years ]reoperation for recurrence and clinical recurrence
- Chronic pain [ Time Frame: Follow-up time up to 4 years ]Degree of pain and/or discomfort in the area of incision
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 ClinicalTrials.gov identifier (NCT number): NCT01740882
|Hvidovre University Hospital|
|Hvidovre, Denmark, 2650|
|Principal Investigator:||Mette W Christoffersen, M.D.||Hvidovre University Hospital|