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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01237470
Recruitment Status : Terminated (protocol completed)
First Posted : November 9, 2010
Last Update Posted : November 9, 2010
Information provided by:
Nicolaus Copernicus University

Brief Summary:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. recurrence [ Time Frame: 3 years ]
    hernia recurrence after surgical treatement

  2. chronic pain [ Time Frame: 6 months ]
    persistent chronic pain (lasting longer then 6 months)

Secondary Outcome Measures :
  1. surgical complications [ Time Frame: 3 years ]
    edema, hematoma, ecchymosis, infaction of the wound

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01237470

Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University
Bydgoszcz, Poland, 85-094
Sponsors and Collaborators
Nicolaus Copernicus University
Study Chair: Stanislaw Dabrowiecki, MD, PhD Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland

Responsible Party: Nicolaus Copernicus University Identifier: NCT01237470     History of Changes
Other Study ID Numbers: Nicolaus Copernicus University
First Posted: November 9, 2010    Key Record Dates
Last Update Posted: November 9, 2010
Last Verified: July 2010

Keywords provided by Nicolaus Copernicus University:
inguinal hernia
hernia recurrence
no mesh techniques
Desarda technique

Additional relevant MeSH terms:
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal