NCT06821438

Brief Summary

The purpose of the study is to compare the reliability and accuracy of systematic ultrasonographic scanning using International Deep Endometriosis Analysis group approach versus magnetic resonance imaging (MRI) assessment in diagnosis of patients with deep infiltrative endometriosis in comparison with the intraoperative findings to confirm the accuracy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2025

Completed
27 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

January 5, 2025

Last Update Submit

February 9, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • TRANSVAGINAL ULTRASOUND VERSUS MAGNETIC RESONANCE IMAGING IN DIAGNOSIS OF LAPAROSCOPICALLY MANAGED PATIENTS WITH DEEP INFILTRATING ENDOMETRIOSIS

    The purpose of the study is to compare the reliability and accuracy of systematic ultrasonographic scanning using International Deep Endometriosis Analysis group approach versus magnetic resonance imaging (MRI) assessment in diagnosis of patients with deep infiltrative endometriosis in comparison with intraoperative findings to confirm the diagnosis .

    Baseline

Interventions

LaparoscopyPROCEDURE

Endoscopy

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Patients with Deep Infiltrating Endometriosis affecting ovaries (endometriomas), rectosigmoid , bladder or any type of endometriosis who suffers from chronic pelvic pain, dysmenorrhea, dyspareunia, dyschasia, dysuria or infertility. All cases included were subjected to the following: History taking, analysis of complaint, physical examination , transvaginal sonography, MRI and laparoscopy. These are done after informed written consents.

You may qualify if:

  • Known patient with Deep Infiltrating Endometriosis affecting ovaries (endometriomas), rectosigmoid , bladder or any type of endometriosis who suffers from chronic pelvic pain, dysmenorrhea, dyspareunia, dyschasia, dysuria or infertility.

You may not qualify if:

  • Postmenopausal status.
  • Women with malignancy or adnexal lesions other than suspected endometrioma.
  • Those who were pregnant.
  • History of any metallic implants or prosthesis preventing MRI. 5. Virgin cases (No Transvaginal Ultrasound).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria Faculty Of Medicine

Alexandria, El Shatby, 21526, Egypt

Location

MeSH Terms

Conditions

Endometriosis

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Rawan El Sawy, Bachelor

CONTACT

Tamer Hosny, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator Dr Tamer Ahmed Hosny

Study Record Dates

First Submitted

January 5, 2025

First Posted

February 12, 2025

Study Start

February 1, 2025

Primary Completion

April 1, 2025

Study Completion

May 1, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations