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

November 7, 2024 updated by: Alsadig Suliman, Sudan Medical Specialization Board

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

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 Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
    • Gazira
      • wad ALnaeem, Gazira, Sudan, 12111
        • Al-Waleedeen Specialized Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complication Rates
Time Frame: Up to 3 months post-surgery
Number of patients experiencing postoperative complications. Unit of Measure: Percentage of total patients.
Up to 3 months post-surgery
Hernia Recurrence Rates
Time Frame: Up to 3 months post-surgery .
Number of patients with recurrence of hernia after initial repair. Unit of Measure: Percentage of total patients.
Up to 3 months post-surgery .

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Level
Time Frame: Assessed 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).
Assessed at 24 hours, 72 hours, and 1 week post-surgery.
Duration of Hospital Stay
Time Frame: From date of surgery to discharge, within 30 days post-surgery
Length of hospital stay post-surgery. Unit of Measure: Number of days from surgery to discharge.
From date of surgery to discharge, within 30 days post-surgery
Recovery Times
Time Frame: Assessed 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.
Assessed at 2 weeks, 1 month, and 3 months post-surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sudan Medical Specialization Board

Collaborators

Sudan Medical Specialization Board (SMSB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2021

Primary Completion (Actual)

October 11, 2023

Study Completion (Actual)

September 22, 2024

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

November 7, 2024

First Posted (Estimated)

November 8, 2024

Study Record Updates

Last Update Posted (Estimated)

November 8, 2024

Last Update Submitted That Met QC Criteria

November 7, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMSB-HERNIA-001-2024 (Registry Identifier: Inguinal Hernia Repair Methods Study Registry)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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