The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.

NCT ID: NCT01237470

Last Updated: 2010-11-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 2009 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2009-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Desarda group

Patients with primary inguinal hernia operated using the Desarda technique

Group Type: EXPERIMENTAL

Desarda technique

Intervention Type: PROCEDURE

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

Lichtenstein group

Patients with primary inguinal hernia operated using the Lichtenstein technique.

Group Type: EXPERIMENTAL

Lichtenstein technique

Intervention Type: PROCEDURE

hernioplasty with the usage of plain polypropylene mesh

Interventions

Desarda technique

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

Intervention Type: PROCEDURE

Lichtenstein technique

hernioplasty with the usage of plain polypropylene mesh

Intervention Type: PROCEDURE

Other Intervention Names

open plain mesh technique

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Nicolaus Copernicus University

OTHER

Sponsor Role: lead

Responsible Party

Nicolaus Copernicus University

Principal Investigators

Stanislaw Dabrowiecki, MD, PhD

Role: STUDY_CHAIR

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

Locations

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

Bydgoszcz, , Poland

Countries

Poland

References

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.

Reference Type: BACKGROUND

PMID: 11471669 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12697071 (View on PubMed)

Other Identifiers

Nicolaus Copernicus University

Identifier Type: -

Identifier Source: org_study_id