Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair

Umbilical Hernia Clinical Trial

— UMBI-REC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01607801
• Other study ID #: UMBI-123
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: January 30, 2017
• Start date: January 2007
• Est. completion date: December 2010

Study information

• Verified date: January 2017
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4847
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• bigger defect than 2 cm. laparoscopic repair

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Recurrence
• Umbilical Hernia

Locations

Country	Name	City	State
Denmark	Koege Sygehus	Koege

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reoperation as surrogate for recurrence	all patients having hernia recurrence measured as reoperation, cross-checked with National Patient Register	4 years