- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05088824
When and Why Desarda Repair
One of the most significant subjects studied in abdominal wall surgery is inguinal hernia. Its management is very codified.
The main factors evaluating efficient hernia surgery are not only the rate of complications (recurrence and groin pain essentially) but also cost and time to return to normal activities.
Desarda technique is a non-mesh technique described first in 2001. This surgical technique uses a flap of external oblique aponeurosis in place of a mesh. Its singularity remains its low cost, no use of mesh, and less extensive dissection
Mesh repair has its own limitations; it is unphysiological as mesh is used. Chronic inguinal pain, seroma formation, foreign body sensation, risk of mesh infection are common complications and not recommended in strangulated hernias and extra cost involved by the mesh itself.
It involves use of undetached strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal which is based on the physiological principles. This is a physiological repair and is tension free, can be used in strangulated hernia. Recurrence and complication rates equal to or less than Lichtenstein's repair. It's a simple procedure, early ambulation and less time of hospital stay, low cost for the patient as mesh is not used and most importantly no question of mesh related complications such as mesh rejection, infection, migration and foreign body sensation and chronic groin pain which is comparatively low in this procedure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: boshra N. boshra, resident
- Phone Number: +2 01283626403
- Email: boshranashaat4@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
A prospective clinical trial will be conducted on 30 patients diagnosed with oblique inguinal hernia . The study population will go for hernia repair by Desarda technique .
The treatment will be herniorrhaphy. All the patients will be followed up after the 1st week, 1st month, 3 month and after 6 month . The efficacy and adverse effects will be compared by statistical analysis.
Description
Inclusion Criteria:
- primary inguinal hernia
- Aged 18 and above
- reducible inguinal or inguino-scrotal hernia
Exclusion Criteria:
- Obstructive uropathy or chronic obstructive pulmonary disease
- incarcerated hernia
- recurrent hernia
- bilateral hernia
- active infection at groin area
- pantalloon hernia
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients diagnosed with oblique inguinal hernia
|
It involves use of undetached strip of external oblique aponeurosis to strengthen the posterior wall of the inguinal canal which is based on the physiological principles.
This is a physiological repair and is tension free, can be used in strangulated hernia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
postoperative hospital stay
Time Frame: 6 month
|
the duration of postoperative hospital stay
|
6 month
|
|
chronic pain
Time Frame: 6 months
|
the patient will be assed for the presence of feeling of pain after the procedure or not
|
6 months
|
|
recurrence
Time Frame: 6 months
|
the patient will be followed up for recurrence of hernia in the same place by clinical examination
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Desarda
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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