An observational study in Darn Vs. Lichtenstein Hernia Outcomes, Outcomes of Darn and Lichtenstein Hernia Repairs and Bilateral Inguinal Hernia: Darn Vs. Lichtenstein, sponsored by Sudan Medical Specialization Board. Completed at 1 site in Sudan. Open to male participants aged 16 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-11-08.
Sponsored by Sudan Medical Specialization Board · Observational
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.
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.
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's enrollment of 75 is below the median of 134 across 137 observational studies indexed under Hernia, Inguinal.
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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.
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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 ( > 7). Patients diagnosed with cancer, tuberculosis. Patients with giant inguinoscrotal hernias.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Complication Rates
Number of patients experiencing postoperative complications. Unit of Measure: Percentage of total patients.
Time frame: 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.
Time frame: Up to 3 months post-surgery .
Postoperative Pain Level
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).
Time frame: Assessed at 24 hours, 72 hours, and 1 week post-surgery.
Duration of Hospital Stay
Length of hospital stay post-surgery. Unit of Measure: Number of days from surgery to discharge.
Time frame: From date of surgery to discharge, within 30 days post-surgery
Recovery Times
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.
Time frame: Assessed at 2 weeks, 1 month, and 3 months post-surgery.
Plan to share: No — Individual participant data (IPD) will not be shared publicly due to several considerations. First, the data includes sensitive personal health information, which must be protected to comply with privacy regulations and ethical standards. Additionally, the study is conducted in a low-resource setting, where data management and sharing capabilities may be limited. Ensuring the confidentiality and anonymity of participants is paramount, and sharing IPD could compromise these ethical obligations. Finally, the data will be used exclusively for the purpose of this study to inform clinical practice within the context of the local healthcare system, rather than for broader dissemination.
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Ran from Jan 2021 to primary completion in Oct 2023, 33 months.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Sudan Medical Specialization Board