An interventional study of Desarda technique and Lichtenstein technique in Hernia, Inguinal, sponsored by Nicolaus Copernicus University. Terminated at 1 site in Poland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-11-09.
Sponsored by Nicolaus Copernicus University · Not applicable, Interventional, and Treatment
Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.
Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.
The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.
To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.
Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.
1,096 studies on the registry are indexed under Hernia; 132 are open to participants now.
This study's enrollment of 2,009 is above the median of 80 across 739 interventional studies indexed under Hernia.
Browse Hernia studies →Nicolaus Copernicus University is the lead sponsor of 19 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with primary inguinal hernia operated using the Desarda technique
Procedure: Desarda technique
Patients with primary inguinal hernia operated using the Lichtenstein technique.
Procedure: Lichtenstein technique
no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal
hernioplasty with the usage of plain polypropylene mesh
Also known as: open plain mesh technique
recurrence
hernia recurrence after surgical treatement
Time frame: 3 years
chronic pain
persistent chronic pain (lasting longer then 6 months)
Time frame: 6 months
surgical complications
edema, hematoma, ecchymosis, infaction of the wound
Time frame: 3 years
This study is terminated, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.
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Nicolaus Copernicus University