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Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks (ABSTACK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date November 28, 2012
First Posted Date December 4, 2012
Last Update Posted Date April 25, 2014
Study Start Date November 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 30, 2012)
Recurrence [ Time Frame: follow-up time up to 4 years ]
reoperation for recurrence and clinical recurrence
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 18, 2013)
Chronic pain [ Time Frame: Follow-up time up to 4 years ]
Degree of pain and/or discomfort in the area of incision
Original Secondary Outcome Measures
 (submitted: November 30, 2012)
Chronic pain and discomfort [ Time Frame: Follow-up time up to 4 years ]
Degree of pain and/or discomfort in the area of incision
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks
Official Title Risk of Recurrence After Incisional Hernia Repair With Mesh Fixation With Absorbable Versus Non-absorbable Tacks
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Incisional Hernia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 24, 2014)
816
Original Estimated Enrollment
 (submitted: November 30, 2012)
1081
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Denmark
Removed Location Countries  
 
Administrative Information
NCT Number NCT01740882
Other Study ID Numbers ABSTACK-123
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mette Willaume Christoffersen, Hvidovre University Hospital
Study Sponsor Hvidovre University Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Mette W Christoffersen, M.D. Hvidovre University Hospital
PRS Account Hvidovre University Hospital
Verification Date April 2014