IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses

Gynecology Clinical Trial

Official title:

The Diagnostic Value Of International Ovarian Tumour Analysis (IOTA) Simple Rules Versus the Pattern Recognition Method In Differentiating Between Malignant And Benign Adnexal Masses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800031
• Other study ID #: HJ200516
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: November 2018

Study information

• Verified date: January 2019
• Source: Woman's Health University Hospital, Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Ovarian mass more than 5 cm in size (confirmed by transvaginal or transabdominal ultrasonography in gynecology clinic)

• The patient is candidate for abdominal exploration for ovarian Cystectomy or oophorectomy.

Exclusion Criteria:

• Complicated ovarian masses.

• Unfit for surgery.

Related Conditions & MeSH terms

• Gynecology

Intervention

Device:
• Transvaginal ultrasonography

Locations

Country	Name	City	State
Egypt	Kasr el aini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Woman's Health University Hospital, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses		12 month