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Transrectal and 3D Transabdominal Ultrasound Compared to Vaginoscopy in Diagnosing Virgins With Genital Lesions

NCT04858919 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2021-04-26

No results posted yet for this study

Summary

This study is to compare the feasibility and test performance of different 3D pelvic ultrasound and Transrectal ultrasound in the detection of local lesions in the uterus , cervix and vagina compared to the final diagnosis confirmed by vaginoscopy as a golden standard modality of diagnosis in Virgin Patients

Conditions

  • Virginity
  • Genital Diseases, Female
  • Diagnoses Disease

Interventions

DIAGNOSTIC_TEST

3D transabdominal ultrasound

Initially 3D pelvic ultrasound will be performed on all patients. The transabdominal probes used will be those of the ultrasound scanner using a convex probe (multiple frequency 1-6 MHz).

DIAGNOSTIC_TEST

transrectal ultrasound

The vaginal probe will be covered with the customary plastic sheath and richly lubricated with lubricating gel. The probe will then be slowly advanced into the rectum. The transvaginal probes used will be those of the ultrasound scanner using a vaginal probe (multiple frequency 1-8 MHz). The scanning technique will be similar to that of Transvaginal ultrasound.

DIAGNOSTIC_TEST

vaginoscopy

It is the final procedure in the study to reach the accurate diagnosis. A rigid hysteroscope will be used. The sheath has a 5-mm outer diameter, with 2.9 mm rod lens. A high intensity light source and fiberoptic cable will be used to illuminate the uterine cavity. A solution of 0.9% normal saline will be used as the distention medium. The pressure will be kept at 100-120 mmHg using a pressure adjustable cuff system with the aim of maintaining the lowest pressure required to distend the uterine cavity.

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-01
Primary Completion
2021-03-01
Completion
2021-04-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04858919 on ClinicalTrials.gov