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

Sudan Medical Specialization Board

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT06681454

SMSB-HERNIA-001-2024 (Registry Identifier)

Details and patient eligibility

About

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.

Full description

Study Design and Setting

This is a retrospective comparative cohort study undertaken at Al-Waleedeen Specialized Hospital, a governmental tertiary care center in Gezira State, Sudan. The study period spans from January 2021 to October 2023, involving adult males diagnosed with bilateral inguinal hernias.

Study Procedures

Medical records will be systematically reviewed to extract data on surgical technique employed-either Darn or Lichtenstein method. The review will document specific procedural details such as the type of anesthesia used, duration of the surgeries, surgical team composition, and intraoperative management techniques. Information on immediate postoperative care will also be collected, focusing on pain management strategies and mobilization protocols.

Data Collection

The data collection will emphasize capturing precise measures related to surgical outcomes. This includes the exact nature and timing of any postoperative complications (e.g., infection, hematoma, seroma), the precise time to recurrence if applicable, and detailed recovery timelines including return to daily activities and work. All data points will be aligned with the definitions set forth in the STROBE guidelines to maintain consistency and reliability in reporting.

Analytical Methods

The primary analytical approach will involve comparing the frequency and severity of complications between the two surgical methods. Statistical methods will include chi-square tests for categorical data and t-tests for continuous variables, with a significance level set at p<0.05. Kaplan-Meier curves may be used to estimate recurrence rates over the follow-up period, and a Cox proportional hazards model will assess risk factors for recurrence and complications.

Outcome Measures

The main outcome measures will focus on:

Short-term complications within the first three months post-surgery. Long-term hernia recurrence over the follow-up period. Recovery timelines, quantified by time until return to usual activities and work.

Ethical Considerations

The study protocol has been reviewed and approved by the Institutional Review Board at Al-Waleedeen Specialized Hospital. All data will be de-identified to ensure confidentiality and compliance with ethical standards for research involving human subjects.

Enrollment: 75 patients

Sex: Male

Ages: 16 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

75 participants in 2 patient groups

Lichtenstein Repair Cohort

Description:

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

Description:

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.