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

Incisional Hernia Clinical Trial

— ABSTACK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01740882
• Other study ID #: ABSTACK-123
• Status: Completed
• Phase: N/A
• First received: November 28, 2012
• Last updated: April 24, 2014
• Start date: November 2013
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Hvidovre University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Locations

Country	Name	City	State
Denmark	Hvidovre University Hospital	Hvidovre

Sponsors (1)

Lead Sponsor	Collaborator
Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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