The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.

Not Applicable

Terminated

• Conditions: Hernia, Inguinal
• Interventions: Procedure: Desarda technique; Procedure: Lichtenstein technique

• Registration Number: NCT01237470
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2010-07
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-08
• Last Update Submitted: 2010-11-08
• Study First Posted: 2010-11-09
• Last Update Posted: 2010-11-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2009

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desarda group	Desarda technique	Patients with primary inguinal hernia operated using the Desarda technique
Lichtenstein group	Lichtenstein technique	Patients with primary inguinal hernia operated using the Lichtenstein technique.

Primary Outcome Measures

Name	Time	Method
recurrence	3 years	hernia recurrence after surgical treatement
chronic pain	6 months	persistent chronic pain (lasting longer then 6 months)

Secondary Outcome Measures

Name	Time	Method
surgical complications	3 years	edema, hematoma, ecchymosis, infaction of the wound

Trial Locations

Locations (1)

Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University; 🇵🇱 Bydgoszcz, Poland