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Completed

NCT Number: NCT01740882

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

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hvidovre University Hospital

Hvidovre, 2650, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Recurrence

    Time frame: follow-up time up to 4 years

    reoperation for recurrence and clinical recurrence

Secondary outcomes

  1. Chronic pain

    Time frame: Follow-up time up to 4 years

    Degree of pain and/or discomfort in the area of incision

Sponsors and collaborators

Lead sponsor

Hvidovre University Hospital

Other

Registry information

Acronym: ABSTACK

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 4, 2012
Registry last updated
Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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