Clinical trial NCT01740882: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Incisional Hernia
Keywords: incisional hernia
mesh fixation
absorbable tacks
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2012-12-04
Enrollment: 816
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Recurrence
timeFrame: follow-up time up to 4 years
Secondary outcomes:
measure: Chronic pain
timeFrame: Follow-up time up to 4 years
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre University Hospital
name: Mette W Christoffersen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: