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

NCT04858919 | Completed

• 1 other identifier: vaginoscope
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Feasibility of different diagnostic modalities in Virgins.

  By questionnaire to asses the acceptance of patient to undergo different modalities as 3D pelvic ultrasound, Transrectal ultrasound and vaginoscopy is assessed.

  1 to 2 hours

• Test performance of different diagnostic modalities in Virgins

  diagnostic accuracy of 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 Virgins.

  24 hours to 1 week

Secondary Outcomes (2)

• Patients' satisfaction

  1-2 hours

• patients' pain

  1-2 hours

Study Arms (1)

study group

OTHER

virgins with genital tract lesion

Diagnostic Test: 3D transabdominal ultrasound; Diagnostic Test: transrectal ultrasound; Diagnostic Test: vaginoscopy

Interventions

3D transabdominal ultrasound DIAGNOSTIC_TEST

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).

study group

transrectal ultrasound DIAGNOSTIC_TEST

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.

study group

vaginoscopy DIAGNOSTIC_TEST

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.

study group

Eligibility Criteria

• Age: 5 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Virgins complaining of Abnormal vaginal bleeding, abnormal discharge , pelvic pain
• Virgins with Suspected genital tract lesion by examination
• Virgins with Suspected genital tract lesion by pelvic ultrasound

You may not qualify if:

• Sexually Active Patients
• Suspected or documented Pregnancy
• Virgin patients with no suspected uterine, cervical or vaginal lesion by pelvic ultrasound
• Patients unable to communicate effectively

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university faculty of medicine

Cairo, 11591, Egypt

Location

MeSH Terms

Conditions

Sexual Abstinence; Genital Diseases, Female

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The sonographers will be blinded to all images obtained from the initial pelvic ultrasound and from the images obtained by the alternative sonographic modality. Also All sonographic images will be concealed from the physicians performing the vaginoscopy procedure .
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A diagnostic test accuracy study that will be conducted at Ain-Shams University Maternity Hospital ,the patients will be recruited from women admitted from gynecologic clinic or from emergency room and from patients following up in outpatient clinic patients will be recruited to this study All Patients recruited must have suspected uterine, cervical or vaginal lesion by history, examination and Pelvic ultrasound

Study Record Dates

• First Submitted: April 13, 2021
• First Posted: April 26, 2021
• Study Start: June 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 6 months after publishing

Locations

EG (1)