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

NCT04850131 | Completed DMC

• 1 other identifier: 274/IREF\RMU\2020
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain; Recurrence; Wound Complication

Keywords

Desarda Repair; Comparison; Lichtenstein Repair; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Wound complication

  Complications occuring within 30 days after the surgery

Study Arms (2)

Desarda

ACTIVE COMPARATOR

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

Lichtenstein

ACTIVE COMPARATOR

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

Interventions

Desarda repair PROCEDURE

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

Also known as: Lichtenstein repair

Desarda; Lichtenstein

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of age between 20 to 70years
• A primary inguinal hernia
• Consented to participate in the research.

You may not qualify if:

• Age below 20,
• Recurrent and pantaloons hernia
• Patients who did not give the informed consent
• Patients who lose the follow-up

Sponsors & Collaborators

• Benazir Bhutto Hospital, Rawalpindi: lead

Study Sites (1)

Benazir Bhutto Hospital Rawalpindi

Rawalpindi, Punjab Province, 46000, Pakistan

Location

MeSH Terms

Conditions

Pain, Postoperative; Recurrence

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Disease Attributes

Study Officials

• MUHAMMAD USMAN GHANI, FCPS

  BENAZIR BHUTTO HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SENIOR REGISTRAR SURGERY

Model Details: A total of 82 patients with inguinal hernias were selected randomly to participate in this study. They were subjected to either Lichtenstein hernioplasty or Desarda herniorrhaphy. A follow-up was conducted to analyze the hospital stay, return to work, recurrence rate, chronic pain, postoperative complications, and cost-effectiveness.

Study Record Dates

• First Submitted: April 10, 2021
• First Posted: April 20, 2021
• Study Start: May 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2021
• Last Updated: April 20, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)