Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair

NCT ID: NCT01607801

Last Updated: 2017-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 4847 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2010-12-31

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.

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.

Conditions

Umbilical Hernia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

non-absorbable suture NAS

having their umbilical hernia repaired with NAS

No interventions assigned to this group

Long-term-absorbable suture (LAS)

patients having their umbilical hernia repair with LAS

No interventions assigned to this group

Absorbable sutures (AS)

patients having their umbilical hernia repair with AS

No interventions assigned to this group

Mesh repair

Patients having umbilical hernia mesh repair

No interventions assigned to this group

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Mette M W Christoffersen

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Koege Sygehus

Koege, , Denmark

Countries

Denmark

References

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.

Reference Type: DERIVED

PMID: 23887595 (View on PubMed)

Other Identifiers

UMBI-123

Identifier Type: -

Identifier Source: org_study_id