Clinical trial NCT06681454: Comparing Darn and Lichtenstein Repair for Bilateral Inguinal Hernias in Adult Males in a Low-Resource Setting
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Sudan Medical Specialization Board
Sponsor class: OTHER_GOV
Collaborators: name: Sudan Medical Specialization Board (SMSB)
First posted: 2024-11-08
Enrollment: 75
Sex: MALE
Minimum age (years): 16
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Complication Rates
timeFrame: Up to 3 months post-surgery
measure: Hernia Recurrence Rates
timeFrame: Up to 3 months post-surgery .
Secondary outcomes:
measure: Postoperative Pain Level
timeFrame: Assessed at 24 hours, 72 hours, and 1 week post-surgery.
measure: Duration of Hospital Stay
timeFrame: From date of surgery to discharge, within 30 days post-surgery
measure: Recovery Times
timeFrame: Assessed at 2 weeks, 1 month, and 3 months post-surgery.
Other outcomes:
Locations:
city: wad ALnaeem
country: Sudan
facility: Al-Waleedeen Specialized Hospital
state: Gazira
Study officials:
References: