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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
Sponsor:
Information provided by (Responsible Party):
Mette Willaume Christoffersen, Hvidovre University Hospital

Brief Summary:

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
Incisional Hernia

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Study Type : Observational
Actual Enrollment : 816 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia




Primary Outcome Measures :
  1. Recurrence [ Time Frame: follow-up time up to 4 years ]
    reoperation for recurrence and clinical recurrence


Secondary Outcome Measures :
  1. Chronic pain [ Time Frame: Follow-up time up to 4 years ]
    Degree of pain and/or discomfort in the area of incision



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
During the period 1 January 2008 to 31 June 2012 were recorded 355 laparoscopic incisional hernia operations with absorbable tacks and 726 with non-absorbable tacks were registered in the Dansih Hernia Database. Thus, we include 1081 patients in the study. It is expected that about 300 patients will be offered physical examination.
Criteria

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

Information from the National Library of Medicine

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


Locations
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Denmark
Hvidovre University Hospital
Hvidovre, Denmark, 2650
Sponsors and Collaborators
Hvidovre University Hospital
Investigators
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Principal Investigator: Mette W Christoffersen, M.D. Hvidovre University Hospital
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Responsible Party: Mette Willaume Christoffersen, MD, Hvidovre University Hospital
ClinicalTrials.gov Identifier: NCT01740882    
Other Study ID Numbers: ABSTACK-123
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014
Keywords provided by Mette Willaume Christoffersen, Hvidovre University Hospital:
incisional hernia
mesh fixation
absorbable tacks
Additional relevant MeSH terms:
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Hernia
Recurrence
Incisional Hernia
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Postoperative Complications