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Clinical Trials/NCT06681454
NCT06681454CompletedNot Applicable

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

Sudan Medical Specialization Board1 site in 1 country75 target enrollmentStarted: January 11, 2021Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
75
Locations
1
Primary Endpoint
Hernia Recurrence Rates

Study Overview

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
16 Years to 85 Years (Child, Adult, Older Adult)
Sex
Male
Accepts 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.

Outcomes

Primary Outcomes

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.

Complication Rates

Time Frame: Up to 3 months post-surgery

Number of patients experiencing postoperative complications. Unit of Measure: Percentage of total patients.

Secondary Outcomes

  • Postoperative Pain Level(Assessed at 24 hours, 72 hours, and 1 week post-surgery.)
  • Duration of Hospital Stay(From date of surgery to discharge, within 30 days post-surgery)
  • Recovery Times(Assessed at 2 weeks, 1 month, and 3 months post-surgery.)

Investigators

Sponsor
Sudan Medical Specialization Board
Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Alsadig Suliman

General surgery

Federal Ministry of Health, Sudan

Study Sites (1)

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