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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mette M W Christoffersen, Koege Sygehus
ClinicalTrials.gov Identifier:
NCT01607801
First received: May 25, 2012
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition
Umbilical Hernia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Effect of Reoperation for Recurrence After Open Surgery for Small Umbilical Hernia With Sutured Mesh or Plastic Surgery. A National Hernia Database Study.

Resource links provided by NLM:


Further study details as provided by Koege Sygehus:

Primary Outcome Measures:
  • reoperation as surrogate for recurrence [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    all patients having hernia recurrence measured as reoperation, cross-checked with National Patient Register


Enrollment: 4847
Study Start Date: January 2007
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • bigger defect than 2 cm. laparoscopic repair
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01607801

Locations
Denmark
Koege Sygehus
Koege, Denmark, 4700
Sponsors and Collaborators
Koege Sygehus
  More Information

No publications provided by Koege Sygehus

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mette M W Christoffersen, Medical Doctor, Koege Sygehus
ClinicalTrials.gov Identifier: NCT01607801     History of Changes
Other Study ID Numbers: UMBI-123
Study First Received: May 25, 2012
Last Updated: May 30, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by Koege Sygehus:
umbilical hernia repair
recurrence
choice of suture
mesh
mesh/non-mesh

Additional relevant MeSH terms:
Hernia
Recurrence
Hernia, Umbilical
Pathological Conditions, Anatomical
Disease Attributes
Pathologic Processes
Infant, Newborn, Diseases
Hernia, Ventral
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 18, 2014