The Effect of Absorbable Versus Non-absorbable Sutures Versus Mesh in Umbilical Hernia Repair (ABSNOME)
The best surgical technique for small umbilical hernia repair, including choice of suture and/or mesh is undetermined. Furthermore, a recent study has shown that reoperations rate as a surrogate for recurrence is highly underestimated.
There are few small studies that have examined the prevalence of chronic discomfort after open surgery, but they indicate that 12% may have long-term complaints after their previous operation. The study aims to investigate the degree of clinical recurrence, including reoperation for recurrence, after open repair for small umbilical hernias sutured or with mesh.
There are plans a national prospective study with data from the Danish ventral hernia Database (DVHD) and the National Patient Register (LPR) with the questionnaire and then possibly. Clinical follow-up. In light of perioperative data from DVHD the investigators will seek to identify risk factors for chronic discomfort and pain. There will be executed frequency analyzes and Kaplan Meyer statistics, supplemented by multivariate Cox regression analysis. Use non-parametric statistics.
Ventral Hernia Midline
|Study Design:||Observational Model: Cohort
Time Perspective: Retrospective
|Official Title:||Clinical and Reoperation for Recurrence and Chronic Discomfort After Open Repair for Small Umbilical Hernia With Sutured Mesh or Plastic Surgery. A Retrospective Cohort Study With Questionnaire Follow-up.|
- recurrence [ Time Frame: 2 years ] [ Designated as safety issue: No ]follow-up time will be from 3-5 years
- long-term complaints [ Time Frame: 3-5 years after surgery ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||August 2013 (Final data collection date for primary outcome measure)|
umbilical hernia repair
patients having umbilical or epigastric hernia repair from 2007-2010 in Zealand
Repair of a small umbilical hernias is one of the most common surgical procedures, but the best surgical technique, including the choice of suture or mesh is unclear. It is well known that the use of a resorbable suture, opposite to long-term resorbable vs. non-resorbable sutures, for closing the abdominal wall increases risk of incisional hernias. It has also been found that absorbable suture fixing of the open mesh for inguinal hernia repair leads to greater risk of recurrence of the hernia. Furthermore, smaller studies on umbilical hernia repair has found that the use of the mesh in open operation for small umbilical hernias has lower risk for recurrence (approx. 1-3%) than at the sutured repair (10-12 %).
A recent study has shown that reoperations rate as a surrogate for recurrence is strongly underestimated.
Long-term discomfort seems to be a problem in a recent study. There is no valid studies that explain the causes of chronic discomfort after open repair for small umbilical hernias.
To investigate the degree of clinical recurrence, including reoperations rate after open repair for small umbilical hernias with mesh or sutured repair. Moreover, we investigate long-term complaints after surgery and the causes and risk factors for this.
A national prospective registry study with data from the Danish ventral hernia Database (DVHD) and the National Patient Register (LPR) with a questionnaire follow-up.
We include consecutive patients who have had primary open elective umbilical and epigastrica hernia repair at Danish hospitals reported to DVHD in the period 1th of January 2007 to 31 December 2010. Apart from operator-registered perioperative data from DVHD, operations can be characterized with different types of sutures and choice of mesh and with possible impact on long-term outcome after surgery, including recurrence. To account for the reoperation for hernia recurrence implies an underestimation of the true incidence of recurrence, we mail a short validated questionnaire to all of the regional cohort of patients from Zealand (approx. 2000 patients), whether the patient has undergone surgery for recurrence or suspect a recurrent hernia. In cases of suspected recurrent hernia, patients will be offered clinical examination for clarification. All volunteers receive a thorough written and oral information and obtain informed consent by signing a consent form. Statistical analysis There will be executed frequency analyzes and Kaplan Meyer statistics, supplemented by multivariate Cox regression analysis. Use non-parametric statistics.