Desarda Repair Compared to Lichtenstein Repair for the Treatment of Inguinal Hernias

Mesh Free Desarda Repair Compared With Lichtenstein Repair for the Treatment of Primary Inguinal Hernias

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.

Study Overview

• Status: Completed
• Conditions: Recurrence; Postoperative Pain; Wound Complication
• Intervention / Treatment: Procedure: Desarda repair

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Benazir Bhutto Hospital Rawalpindi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Desarda; Forty-one patients who were randomly assigned to the Desarda group underwent the Desarda repair for their problem. Patients were followed for various data point values during operation, immediately after the operation, and for a period of one year post-operatively.	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; Other Names: Lichtenstein repair
ACTIVE_COMPARATOR: Lichtenstein; Forty-one patients randomly assigned to the Lichtenstein group underwent the standard mesh repair and were followed for the same data point values and variables for the same specified period of time.	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; Other Names: Lichtenstein repair

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain	24 hours after the surgery
Postoperative pain	Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain	3 months after the primary surgery
Recurrence	Described as reappearance of the inguinal hernia on the operated side	Within 01 year of the primary surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Benazir Bhutto Hospital, Rawalpindi
• Investigators: Principal Investigator: MUHAMMAD USMAN GHANI, FCPS, Benazir Bhutto Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2019
• Primary Completion (ACTUAL): March 30, 2020
• Study Completion (ACTUAL): March 30, 2021

Study Registration Dates

• First Submitted: April 10, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (ACTUAL): April 20, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 14, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Comparison; Desarda Repair; Lichtenstein Repair
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Recurrence
• Other Study ID Numbers: 274/IREF\RMU\2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No