Comparing Darn and Lichtenstein Repair for Bilateral Inguinal Hernias in Adult Males in a Low-Resource Setting

NCT06681454 | Completed DMC

• 1 other identifier: SMSB-HERNIA-001-2024
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

This retrospective study evaluates the efficacy of Darn versus Lichtenstein repair methods in treating bilateral inguinal hernias in adult males within a low-resource setting in Sudan. The study aims to determine which surgical technique results in better postoperative outcomes, focusing on complication rates, recurrence, and recovery times. Data for this analysis will be sourced from medical records of patients who underwent these procedures between January 2021 and October 2023 at Al-Waleedeen Specialized Hospital.

Conditions

Darn Vs. Lichtenstein Hernia Outcomes; Outcomes of Darn and Lichtenstein Hernia Repairs; Bilateral Inguinal Hernia: Darn Vs. Lichtenstein

Keywords

Retrospective cohort study; Low-resource setting; Medical records analysis; Bilateral inguinal hernia; Lichtenstein repair method; Darn repair method

Outcome Measures

Primary Outcomes (2)

• Complication Rates

  Number of patients experiencing postoperative complications. Unit of Measure: Percentage of total patients.

  Up to 3 months post-surgery

• Hernia Recurrence Rates

  Number of patients with recurrence of hernia after initial repair. Unit of Measure: Percentage of total patients.

  Up to 3 months post-surgery .

Secondary Outcomes (3)

• Postoperative Pain Level

  Assessed at 24 hours, 72 hours, and 1 week post-surgery.

• Duration of Hospital Stay

  From date of surgery to discharge, within 30 days post-surgery

• Recovery Times

  Assessed at 2 weeks, 1 month, and 3 months post-surgery.

Study Arms (2)

Lichtenstein Repair Cohort

This group consists of adult male patients who underwent bilateral inguinal hernia repair using the Lichtenstein technique. The Lichtenstein method involves the use of a synthetic mesh to provide support to the weakened abdominal wall, minimizing the risk of recurrence and promoting quicker recovery.

Darn Repair Cohort

This group comprises adult male patients who underwent bilateral inguinal hernia repair using the Darn technique. The Darn method is a tension-free repair technique that utilizes the patient's own tissue without the use of mesh, aimed at reducing postoperative pain and complication rates.

Eligibility Criteria

• Age: 16 Years - 85 Years
• Gender Eligibility Details: This indicates that eligibility is limited by biological sex, as the study is focused on adult male patients for the surgical techniques being analyzed
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of adult male patients aged 16 to 85 years who present with bilateral primary direct or indirect inguinal hernias at Al-Waleedeen Specialized Hospital in Gezira State, Sudan. Participants will be selected based on their medical records and will have undergone open elective hernia repair using either the Darn or Lichtenstein technique during the recruitment period from January 2021 to October 2023.

You may qualify if:

• Male patients aged 16 to 85 years. Diagnosed with bilateral primary direct or indirect inguinal hernias. Underwent open elective repairs using either the Lichtenstein or Darn method.

You may not qualify if:

• Patients with recurrent hernias. Female patients. Patients with unilateral hernias. Those undergoing laparoscopic or emergency surgery. Patients with poorly controlled diabetes (A1C \> 7). Patients diagnosed with cancer, tuberculosis. Patients with giant inguinoscrotal hernias.

Sponsors & Collaborators

• Sudan Medical Specialization Board: lead
• Sudan Medical Specialization Board (SMSB): collaborator

Study Sites (1)

Al-Waleedeen Specialized Hospital

Wad ALnaeem, Gazira, 12111, Sudan

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: General surgery

Study Record Dates

• First Submitted: October 24, 2024
• First Posted: November 8, 2024
• Study Start: January 11, 2021
• Primary Completion: October 11, 2023
• Study Completion: September 22, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

SU (1)