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

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.

Study Overview

• Status: Terminated
• Conditions: Hernia, Inguinal
• Intervention / Treatment: Procedure: Desarda technique; Procedure: Lichtenstein technique

• Study Type: Interventional
• Enrollment (Actual): 2009
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland, 85-094
    • Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: open plain mesh technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
recurrence	hernia recurrence after surgical treatement	3 years
chronic pain	persistent chronic pain (lasting longer then 6 months)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgical complications	edema, hematoma, ecchymosis, infaction of the wound	3 years

Collaborators and Investigators

• Sponsor: Nicolaus Copernicus University
• Investigators: Study Chair: Stanislaw Dabrowiecki, MD, PhD, Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University Bydgoszcz, Poland

Publications and helpful links

General Publications

• Desarda MP. Inguinal herniorrhaphy with an undetached strip of external oblique aponeurosis: a new approach used in 400 patients. Eur J Surg. 2001 Jun;167(6):443-8. doi: 10.1080/110241501750243798.
• Desarda MP. Surgical physiology of inguinal hernia repair--a study of 200 cases. BMC Surg. 2003 Apr 16;3:2. doi: 10.1186/1471-2482-3-2.

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 8, 2010
• First Submitted That Met QC Criteria: November 8, 2010
• First Posted (Estimate): November 9, 2010

Study Record Updates

• Last Update Posted (Estimate): November 9, 2010
• Last Update Submitted That Met QC Criteria: November 8, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: inguinal hernia; hernia recurrence; no mesh techniques; Desarda technique
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: Nicolaus Copernicus University