Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair (UMBI-REC)

January 30, 2017 updated by: Mette M W Christoffersen, Zealand University Hospital

Effect of Reoperation for Recurrence After Open Surgery for Small Umbilical Hernia With Sutured Mesh or Plastic Surgery. A National Hernia Database Study.

background Operation for small umbilical hernias is one of the most common surgical procedures, but the best surgical technique, including the choice of suture or mesh remains unknown.

It is well known that using non-absorbable sutures in closure of the abdomen, diminishes the risk of incisional hernias and wound healing problems.It has also been found that the use of resorbable suture in fixation of the mesh in Lichtesteins procedure leads to greater risk of recurrence of the hernia. Furthermore, it has been stated in smaller studies, that the use of the mesh in open operation for a small umbilical hernia has lower risk of recurrence (approx. 1-3%) than sutured repair (10-12 %). However, the scientific literature is deficient, with few patients.

The purpose of this study is to describe reoperation rate of recurrence after small umbilical hernias, depending on choice of sutures in both regular repair and in mesh repair.

Hypothesis: sutured repair with non-absorbable suture has lower recurrence rates than with other types of sutures, whereas mesh repair has even lower recurrence rates in small umbilical hernia repairs.

Study Overview

Status

Completed

Conditions

Detailed Description

National prospective registry study with data from the Danish ventral hernia Database (DVHD) and the National Patient Register (LPR) in patients undergoing open to umbilical or epigastric hernia repair during the period 1 January 2007 to 31 December 2010.

Apart from operator-registered perioperative data from DVHD, operations can be characterized with different types of sutures, choice of mesh and other relevant information, with possible impact on long-term outcome after surgery, including recurrence.

There will be used frequency analyzes and Kaplan Meyer statistics, supplemented by multivariate Cox regression analysis, as well as non-parametric statistics.

Eligibility criteria: OPen mesh or sutured repair for small umbilical hernias from 1th of January 2007 to 31th of December 2010.

Outcome measures: Reoperation as a surrogate for recurrence.

Study Type

Observational

Enrollment (Actual)

4847

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Koege, Denmark, 4700
        • Koege Sygehus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Danish patients undergoing umbilical hernia repair, mesh/non-mesh, under 2 cm. in the study period 1. january 2007 to 31. december 2010.

Description

Inclusion Criteria:

  • Mesh or non-mesh umbilical hernia repair hernia defect size max. 2 cm.

Exclusion Criteria:

  • bigger defect than 2 cm. laparoscopic repair

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
non-absorbable suture NAS
having their umbilical hernia repaired with NAS
Long-term-absorbable suture (LAS)
patients having their umbilical hernia repair with LAS
Absorbable sutures (AS)
patients having their umbilical hernia repair with AS
Mesh repair
Patients having umbilical hernia mesh repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reoperation as surrogate for recurrence
Time Frame: 4 years
all patients having hernia recurrence measured as reoperation, cross-checked with National Patient Register
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

May 25, 2012

First Submitted That Met QC Criteria

May 29, 2012

First Posted (Estimate)

May 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 31, 2017

Last Update Submitted That Met QC Criteria

January 30, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMBI-123

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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