IOTA Versus Pattern Recognition Method in Diagnosis of Ovarian Masses

NCT02800031 | Completed DMC

• 1 other identifier: HJ200516
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gynecology

Outcome Measures

Primary Outcomes (1)

• comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses

  12 month

Study Arms (1)

Participants

EXPERIMENTAL

* 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.

Device: Transvaginal ultrasonography

Interventions

Transvaginal ultrasonography DEVICE

Participants

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Complicated ovarian masses.
• Unfit for surgery.

Sponsors & Collaborators

• Woman's Health University Hospital, Egypt: lead

Study Sites (1)

Kasr el aini hospital

Cairo, 12211, Egypt

Location

Related Publications (1)

• Dakhly DMR, Gaafar HM, Sediek MM, Ibrahim MF, Momtaz M. Diagnostic value of the International Ovarian Tumor Analysis (IOTA) simple rules versus pattern recognition to differentiate between malignant and benign ovarian masses. Int J Gynaecol Obstet. 2019 Dec;147(3):344-349. doi: 10.1002/ijgo.12970. Epub 2019 Sep 26.

  PMID: 31520402 DERIVED

Study Officials

• Dina MR Dakhly, MD

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Masking: NONE
• Masking Details: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: June 15, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: January 8, 2019

Record last verified: 2019-01

Locations

EG (1)