Umbilical Hernia Clinical Trial
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.
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.
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.
;
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