IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses

Woman's Health University Hospital, Egypt

Status: Completed

Conditions: Gynecology

Treatments: Device: Transvaginal ultrasonography

Study type: Interventional

Funder types: Other

Identifiers

NCT02800031

HJ200516

Details and patient eligibility

About

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

Enrollment: 396 patients

Sex: Female

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

396 participants in 1 patient group

Participants

Experimental group

Description:

* 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.

Treatment:

Device: Transvaginal ultrasonography