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

Nicolaus Copernicus University

Status: Terminated

Conditions: Hernia, Inguinal

Treatments: Procedure: Lichtenstein technique; Procedure: Desarda technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01237470

Nicolaus Copernicus University

Details and patient eligibility

About

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.

Enrollment: 2,009 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

2,009 participants in 2 patient groups

Desarda group

Experimental group

Description:

Patients with primary inguinal hernia operated using the Desarda technique

Treatment:

Procedure: Desarda technique

Lichtenstein group

Experimental group

Description:

Patients with primary inguinal hernia operated using the Lichtenstein technique.

Treatment:

Procedure: Lichtenstein technique