Effect of Reoperation for Recurrence After Open Umbilical Hernia Repair

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Koege Sygehus

Koege, 4700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

bigger defect than 2 cm. laparoscopic repair

Treatment and study plan

Primary outcomes

reoperation as surrogate for recurrence

Time frame: 4 years

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

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Acronym: UMBI-REC

Important dates

Study start: 2007
Primary completion: 2010
Study completion: 2010
First posted: May 30, 2012
Registry last updated: Jan 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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