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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02329938
Other study ID # MFM200956
Secondary ID
Status Completed
Phase N/A
First received December 30, 2014
Last updated December 30, 2014
Start date December 2010
Est. completion date December 2014

Study information

Verified date December 2014
Source Mansoura University
Contact n/a
Is FDA regulated No
Health authority Egypt: 'Mansoura Faculty of medicine
Study type Interventional

Clinical Trial Summary

Unlike Lichtenstein tension free repair for inguinal hernia, Desarda's repair was introduced as a pure tissue repair with no need for mesh. In other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. The idea was to evaluate the efficacy of this new repair and compare it to the standard Lichtenstein repair.


Recruitment information / eligibility

Status Completed
Enrollment 155
Est. completion date December 2014
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- inguinal hernia

Exclusion Criteria:

- recurrent inguinal hernia

- giant inguinal hernia

- mental disorder

- refusal to participate

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Lichtenstein tension free reair
a mesh is apllied on the posterior wall of the inguinal canal and sutured to the inguinal ligament below, to the internal oblique muscle above , and to rectus sheath medially.
Desarda's repair
the repair is done using a flap of the external oblique aponeurosis sutured to the inguinal ligament below and to the aponeurotic part of the internal oblique muscle above.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Mansoura University

Outcome

Type Measure Description Time frame Safety issue
Primary number of patients with recurrence of inguinal hernia 2 years Yes
Secondary VAS score for pain one year Yes
Secondary number of patients develped postoperative complications 2 years Yes
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