IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses

Not Applicable

Completed

• Conditions: Gynecology
• Interventions: Device: Transvaginal ultrasonography

• Registration Number: NCT02800031
• Lead Sponsor: Woman's Health University Hospital, Egypt

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-06-11
• Study First Posted: 2016-06-15
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-06
• Last Update Posted: 2019-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 396

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Participants	Transvaginal ultrasonography	* Level-II Transvaginal ultrasonography will be done by the principle investigator (who is unaware about the recognition pattern method) to confirm the presence of the ovarian mass and measure its size and to apply the IOTA simple rules on it (complimentary transabdominal ultrasound might be done for huge pelvi-abdominal masses originating from the ovary). * Level-III ultrasound will be done by expert ultrasound operator (who is blinded to the results of IOTA simple rules assessment of the examined mass) to classify the mass (either benign or malignant) using the pattern recognition method. * Plan of management for each patient will be based solely on the findings of pattern recognition and the patient's wishes. * Exploratory laparotomy for excision of the ovarian mass either by ovarian Cystectomy or oophorectomy. * All specimens will be examined histopathologically.

Primary Outcome Measures

Name	Time	Method
comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses	12 month

Trial Locations

Locations (1)

Kasr el aini hospital; 🇪🇬 Cairo, Egypt