Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair

NCT01607801 | Completed DMC

• 1 other identifier: UMBI-123
• Study Type: observational
• Target: 4,847
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Umbilical Hernia

Keywords

umbilical hernia repair; recurrence; choice of suture; mesh; mesh/non-mesh

Outcome Measures

Primary Outcomes (1)

• reoperation as surrogate for recurrence

  all patients having hernia recurrence measured as reoperation, cross-checked with National Patient Register

  4 years

Study Arms (4)

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• bigger defect than 2 cm. laparoscopic repair

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Koege Sygehus

Koege, 4700, Denmark

Location

Related Publications (1)

• Christoffersen MW, Helgstrand F, Rosenberg J, Kehlet H, Bisgaard T. Lower reoperation rate for recurrence after mesh versus sutured elective repair in small umbilical and epigastric hernias. A nationwide register study. World J Surg. 2013 Nov;37(11):2548-52. doi: 10.1007/s00268-013-2160-0.

  PMID: 23887595 DERIVED

MeSH Terms

Conditions

Hernia, Umbilical; Recurrence

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hernia, Ventral; Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Design

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

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: May 30, 2012
• Study Start: January 1, 2007
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: January 31, 2017

Record last verified: 2017-01

Locations

DK (1)