The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment. (DESLICH)

This study has been terminated.
(protocol completed)
Sponsor:
Information provided by:
Nicolaus Copernicus University
ClinicalTrials.gov Identifier:
NCT01237470
First received: November 8, 2010
Last updated: NA
Last verified: July 2010
History: No changes posted

November 8, 2010
November 8, 2010
January 2005
June 2009   (final data collection date for primary outcome measure)
  • recurrence [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    hernia recurrence after surgical treatement
  • chronic pain [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    persistent chronic pain (lasting longer then 6 months)
Same as current
No Changes Posted
surgical complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
edema, hematoma, ecchymosis, infaction of the wound
Same as current
Not Provided
Not Provided
 
The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.
The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hernia, Inguinal
  • Procedure: Desarda technique
    no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal
  • Procedure: Lichtenstein technique
    hernioplasty with the usage of plain polypropylene mesh
    Other Name: open plain mesh technique
  • Experimental: Desarda group
    Patients with primary inguinal hernia operated using the Desarda technique
    Intervention: Procedure: Desarda technique
  • Experimental: Lichtenstein group
    Patients with primary inguinal hernia operated using the Lichtenstein technique.
    Intervention: Procedure: Lichtenstein technique

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2009
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • primary inguinal hernia
  • male adults
  • signed informed consent
  • god condition of external oblique aponeurosis (assessed during the operation)

Exclusion Criteria:

  • age < 18
  • recurrent hernia
  • incarcerated hernia
  • diagnosed mental disorder
  • manual reduction of hernia on inpatient
  • infection at groin area
  • wound or scar at the groin
  • no consent
Male
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01237470
Nicolaus Copernicus University
Yes
Nicolaus Copernicus University
Nicolaus Copernicus University
Not Provided
Study Chair: Stanislaw Dabrowiecki, MD, PhD Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland
Nicolaus Copernicus University
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP