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The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.

NCT01237470 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2009

Last updated 2010-11-09

No results posted yet for this study

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.

Conditions

  • Hernia, Inguinal

Interventions

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

Sponsors & Collaborators

  • Nicolaus Copernicus University

    lead OTHER

Principal Investigators

  • Stanislaw Dabrowiecki, MD, PhD · Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01237470 on ClinicalTrials.gov