IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

396 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Gynecology

Study Design

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Intervention Model

SEQUENTIAL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

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.

Study Groups

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Participants

* 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.

Group Type EXPERIMENTAL

Transvaginal ultrasonography

Intervention Type DEVICE

Interventions

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Transvaginal ultrasonography

Intervention Type DEVICE

Eligibility Criteria

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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.