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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
  Purpose

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 Intervention
Hernia, Inguinal
 Procedure: Desarda technique
Procedure: Lichtenstein technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.

Resource links provided by NLM:

MedlinePlus related topics: Chronic Pain Hernia
U.S. FDA Resources

Further study details as provided by Nicolaus Copernicus University:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • surgical complications [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    edema, hematoma, ecchymosis, infaction of the wound


Enrollment: 2009
Study Start Date: January 2005
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01237470

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

Publications:

Responsible Party: Nicolaus Copernicus University
ClinicalTrials.gov Identifier: NCT01237470     History of Changes
Other Study ID Numbers: Nicolaus Copernicus University
Study First Received: November 8, 2010
Last Updated: November 8, 2010
Health Authority: Poland: Ethics Committee

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

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

ClinicalTrials.gov processed this record on May 16, 2013