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

• Sponsor: Benazir Bhutto Hospital, Rawalpindi (Other)
• Overall Status: Completed
• CT.gov ID: NCT04850131
• Collaborator: (none)
• Enrollment: 82
• Location: 1
• Arms: 2
• Actual Duration (Months): 23
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain; Recurrence; Wound Complication	Procedure: Desarda repair	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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.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: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Mesh Free Desarda Repair Compared With Lichtenstein Repair for the Treatment of Primary Inguinal Hernias
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Mar 30, 2020
• Actual Study Completion Date: Mar 30, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Postoperative pain [24 hours after the surgery]

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

2. Postoperative pain [3 months after the primary surgery]

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

3. Recurrence [Within 01 year of the primary surgery]

   Described as reappearance of the inguinal hernia on the operated side

Secondary Outcome Measures

1. Wound complication [Complications occuring within 30 days after the surgery]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Benazir Bhutto Hospital Rawalpindi	Rawalpindi	Punjab	Pakistan	46000

Sponsors and Collaborators

• Benazir Bhutto Hospital, Rawalpindi

Investigators

• Principal Investigator: MUHAMMAD USMAN GHANI, FCPS, BENAZIR BHUTTO HOSPITAL

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Usman Ghani, SENIOR REGISTRAR SURGERY, Benazir Bhutto Hospital, Rawalpindi
• ClinicalTrials.gov Identifier: NCT04850131
• Other Study ID Numbers: 274/IREF\RMU\2020
• First Posted: Apr 20, 2021
• Last Update Posted: Apr 20, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Muhammad Usman Ghani, SENIOR REGISTRAR SURGERY, Benazir Bhutto Hospital, Rawalpindi: Desarda Repair; Comparison; Lichtenstein Repair; Randomized Controlled Trial
• Additional relevant MeSH terms: Recurrence; Hernia, Inguinal

Study Results

No Results Posted as of Apr 20, 2021