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

Retrospective Comparative Cohort Analysis of Darn and Lichtenstein Repair Methods for Bilateral Inguinal Hernias in Adult Males in a Low-Resource Setting: a Single-Centre Study in Sudan

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06681454
Enrollment
75
Registered
2024-11-08
Start date
2021-01-11
Completion date
2024-09-22
Last updated
2024-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Detailed 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.

Interventions

None listed

Sponsors

Sudan Medical Specialization Board (SMSB)
CollaboratorOTHER_GOV
Sudan Medical Specialization Board
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
16 Years to 85 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Complication RatesUp to 3 months post-surgeryNumber of patients experiencing postoperative complications. Unit of Measure: Percentage of total patients.
Hernia Recurrence RatesUp to 3 months post-surgery .Number of patients with recurrence of hernia after initial repair. Unit of Measure: Percentage of total patients.

Secondary

MeasureTime frameDescription
Postoperative Pain LevelAssessed at 24 hours, 72 hours, and 1 week post-surgery.Average pain scores reported by patients using the Visual Analog Scale. Unit of Measure: Pain score on a scale from 0 (no pain) to 10 (worst possible pain).
Duration of Hospital StayFrom date of surgery to discharge, within 30 days post-surgeryLength of hospital stay post-surgery. Unit of Measure: Number of days from surgery to discharge.
Recovery TimesAssessed at 2 weeks, 1 month, and 3 months post-surgery.Time taken for patients to return to usual activities/work post-surgery. Unit of Measure: Number of days from surgery to return to usual activities.

Countries

Sudan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026