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

Primary Purpose

Postoperative Pain, Recurrence, Wound Complication

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Desarda repair

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring Desarda Repair, Comparison, Lichtenstein Repair, Randomized Controlled Trial

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Benazir Bhutto Hospital Rawalpindi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Desarda

Lichtenstein

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Postoperative pain

Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain

Postoperative pain

Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain

Recurrence

Described as reappearance of the inguinal hernia on the operated side

Secondary Outcome Measures

Wound complication

Described as number of patients developing the wound complications like seroma , hematoma formation and surgical site infection.

Full Information

NCT ID

NCT04850131

First Posted

April 10, 2021

Last Updated

April 14, 2021

Sponsor

Benazir Bhutto Hospital, Rawalpindi

1. Study Identification

Unique Protocol Identification Number

NCT04850131

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

May 1, 2019 (Actual)

Primary Completion Date

March 30, 2020 (Actual)

Study Completion Date

March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Benazir Bhutto Hospital, Rawalpindi

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Pain, Recurrence, Wound Complication

Keywords

Desarda Repair, Comparison, Lichtenstein Repair, Randomized Controlled Trial

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

82 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Desarda

Arm Type

Active Comparator

Arm Description

Arm Title

Lichtenstein

Arm Type

Active Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Desarda repair

Other Intervention Name(s)

Lichtenstein repair

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative pain

Description

Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain

Time Frame

24 hours after the surgery

Title

Postoperative pain

Description

Measured on Visual analogue scale (VAS) where 0 meaning no pain and 10 means worst pain

Time Frame

3 months after the primary surgery

Title

Recurrence

Description

Described as reappearance of the inguinal hernia on the operated side

Time Frame

Within 01 year of the primary surgery

Secondary Outcome Measure Information:

Title

Wound complication

Description

Described as number of patients developing the wound complications like seroma , hematoma formation and surgical site infection.

Time Frame

Complications occuring within 30 days after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of age between 20 to 70years A primary inguinal hernia Consented to participate in the research. Exclusion Criteria: Age below 20, Recurrent and pantaloons hernia Patients who did not give the informed consent Patients who lose the follow-up

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

MUHAMMAD USMAN GHANI, FCPS

Organizational Affiliation

BENAZIR BHUTTO HOSPITAL

Official's Role

Principal Investigator

Facility Information:

Facility Name

Benazir Bhutto Hospital Rawalpindi

City

Rawalpindi

State/Province

Punjab

ZIP/Postal Code

46000

Country

Pakistan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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