The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment. (DESLICH)
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|ClinicalTrials.gov Identifier: NCT01237470|
Recruitment Status : Terminated (protocol completed)
First Posted : November 9, 2010
Last Update Posted : November 9, 2010
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.
|Condition or disease||Intervention/treatment||Phase|
|Hernia, Inguinal||Procedure: Desarda technique Procedure: Lichtenstein technique||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2009 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.|
|Study Start Date :||January 2005|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
Experimental: Desarda group
Patients with primary inguinal hernia operated using the Desarda technique
Procedure: Desarda technique
no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal
Experimental: Lichtenstein group
Patients with primary inguinal hernia operated using the Lichtenstein technique.
Procedure: Lichtenstein technique
hernioplasty with the usage of plain polypropylene mesh
Other Name: open plain mesh technique
- recurrence [ Time Frame: 3 years ]hernia recurrence after surgical treatement
- chronic pain [ Time Frame: 6 months ]persistent chronic pain (lasting longer then 6 months)
- surgical complications [ Time Frame: 3 years ]edema, hematoma, ecchymosis, infaction of the wound
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237470
|Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University|
|Bydgoszcz, Poland, 85-094|
|Study Chair:||Stanislaw Dabrowiecki, MD, PhD||Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland|