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

NCT01740882 | Completed

• 1 other identifier: ABSTACK-123
• Study Type: observational
• Target: 816
• Locations: 1 country
• Sites: 1

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.

Conditions

Incisional Hernia

Keywords

incisional hernia; mesh fixation; absorbable tacks

Outcome Measures

Primary Outcomes (1)

• Recurrence

  reoperation for recurrence and clinical recurrence

  follow-up time up to 4 years

Secondary Outcomes (1)

• Chronic pain

  Follow-up time up to 4 years

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• lost to follow-up
• emigration

Sponsors & Collaborators

• Hvidovre University Hospital: lead

Study Sites (1)

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Location

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Study Officials

• Mette W Christoffersen, M.D.

  Hvidovre University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: December 4, 2012
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: April 25, 2014

Record last verified: 2014-04

Locations

DK (1)