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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04850131
Other study ID # 274/IREF\RMU\2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date March 30, 2021

Study information

Verified date April 2021
Source Benazir Bhutto Hospital, Rawalpindi
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Lichtenstein technique for hernia repair is safe and simple, but the underlying mesh prosthesis has its setbacks, as it acts as a mechanical barrier5. The mesh does not provide mobile and the physiologically dynamic posterior wall. The most dangerous complication associated with the mesh prosthesis is its migration from the abdominal cavity's primary implantation site. The relatively knew technique developed by Dr. Desarda does not utilize the synthetic mesh rather it uses a strip of external oblique aponeurosis to strengthen the posterior wall. Our study has compared the two methods regarding various aspects.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date March 30, 2021
Est. primary completion date March 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: 1. Patients of age between 20 to 70years 2. A primary inguinal hernia 3. Consented to participate in the research. Exclusion Criteria: 1. Age below 20, 2. Recurrent and pantaloons hernia 3. Patients who did not give the informed consent 4. Patients who lose the follow-up

Study Design


Intervention

Procedure:
Desarda repair
Desarda is a new tissue-based technique developed from applying the externally oblique muscle aponeurosis in the form of an undetached strip making the posterior wall in the inguinal canal stiffer. This paper focuses on analyzing comparisons between mesh-free Desarda repair and the Lichtenstein technique for the treatment of hernia inguinalis

Locations

Country Name City State
Pakistan Benazir Bhutto Hospital Rawalpindi Rawalpindi Punjab

Sponsors (1)

Lead Sponsor Collaborator
Benazir Bhutto Hospital, Rawalpindi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative pain Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain 24 hours after the surgery
Primary Postoperative pain Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain 3 months after the primary surgery
Primary Recurrence Described as reappearance of the inguinal hernia on the operated side Within 01 year of the primary surgery
Secondary Wound complication Described as number of patients developing the wound complications like seroma , hematoma formation and surgical site infection. Complications occuring within 30 days after the surgery
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