- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02329938
Desarda Repair for Inguinal Hernia
December 30, 2014 updated by: Tamer Youssef Mohamed, Mansoura University
Desarda Versus Lichtenstein's Repair for Inguinal Hernia: a Comparative Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
155
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- inguinal hernia
Exclusion Criteria:
- recurrent inguinal hernia
- giant inguinal hernia
- mental disorder
- refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Lichtenstein tension free reair
mesh repair of inguinal hernia
|
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.
Other Names:
|
|
ACTIVE_COMPARATOR: Desarda's repair
non-mesh repair of inguinal hernia
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
number of patients with recurrence of inguinal hernia
Time Frame: 2 years
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
VAS score for pain
Time Frame: one year
|
one year
|
|
number of patients develped postoperative complications
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (ACTUAL)
December 1, 2012
Study Completion (ACTUAL)
December 1, 2014
Study Registration Dates
First Submitted
December 30, 2014
First Submitted That Met QC Criteria
December 30, 2014
First Posted (ESTIMATE)
January 1, 2015
Study Record Updates
Last Update Posted (ESTIMATE)
January 1, 2015
Last Update Submitted That Met QC Criteria
December 30, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MFM200956
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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