The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.

NCT01237470 | Terminated DMC

• 1 other identifier: Nicolaus Copernicus University
• Study Type: interventional
• Target: 2,009
• Locations: 1 country
• Sites: 1

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.

Conditions

Hernia, Inguinal

Keywords

inguinal hernia; hernia recurrence; no mesh techniques; Desarda technique

Outcome Measures

Primary Outcomes (2)

• recurrence

  hernia recurrence after surgical treatement

  3 years

• chronic pain

  persistent chronic pain (lasting longer then 6 months)

  6 months

Secondary Outcomes (1)

• surgical complications

  3 years

Study Arms (2)

Desarda group

EXPERIMENTAL

Patients with primary inguinal hernia operated using the Desarda technique

Procedure: Desarda technique

Lichtenstein group

EXPERIMENTAL

Patients with primary inguinal hernia operated using the Lichtenstein technique.

Procedure: Lichtenstein technique

Interventions

Desarda technique PROCEDURE

no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal

Desarda group

Lichtenstein technique PROCEDURE

hernioplasty with the usage of plain polypropylene mesh

Also known as: open plain mesh technique

Lichtenstein group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary inguinal hernia
• male adults
• signed informed consent
• god condition of external oblique aponeurosis (assessed during the operation)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nicolaus Copernicus University: lead

Study Sites (1)

Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University

Bydgoszcz, 85-094, Poland

Location

Related Publications (2)

• 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.

  PMID: 11471669 BACKGROUND

• 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.

  PMID: 12697071 BACKGROUND

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Stanislaw Dabrowiecki, MD, PhD

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 8, 2010
• First Posted: November 9, 2010
• Study Start: January 1, 2005
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 9, 2010

Record last verified: 2010-07

Locations

PL (1)