(GI-RADS) in Preoperative Evaluation of Adnexal Masses

Diagnostic Performance of the Gynecologic Imaging-Reporting and Data System (GI-RADS) in Preoperative Evaluation of Adnexal Masses

prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

Study Overview

• Status: Completed
• Conditions: Ovarian Cancer
• Intervention / Treatment: Diagnostic test: The Gynecologic Imaging-Reporting and Data System (GI-RADS)

Detailed Description

After institutional ethical committee approval () and informed consent from the patients, this prospective study was conducted and performed on 100 women with pelvic pain due to accidently discovered adnexal mass

All women were subjected to the following:

1. Detailed history taking: Personal history, Age, Obstetric history, past history and family history.
2. Physical examination: General examination, Pelvic examination and Abdominal examination.
3. Investigations: Routine labs; CBC, liver and kidney functions, FBS and 2HPP. Other labs; cancer antigen 125 (CA 125) as a tumor marker.
4. Trans vaginal ultrasound: TVUS Written informed consent for participation and publication was obtained from each patient after receiving information about the details of the study. Confidentiality of patient's records was assured and maintained throughout the study.

One hundred (100) patients' pelvises were examined by transvaginal ultrasound in lithotomy position using endo-vaginal transducer and/or transabdominal ultrasound in the supine position in transverse and longitudinal plane and evaluated by B-mode ultrasonography, color, and spectral Doppler. Two expert examiners with more than 10 years' experience in gynecological ultrasound, performed all examinations and data was stored between one and four representative images on the database.

After the examinations, a combination of morphological features, color and spectral Doppler features, and then the lesion was evaluated according to GI-RADS classification, and the suggested management protocol based on the risk of malignancy.

Finally, the referral to surgery and decision-making were consulted in accordance with a multidisciplinary team meeting (MDT). A definitive histopathological diagnosis was obtained as a gold standard test for all patients with GI-RADS 4 and 5 and some cases of GI-RADS 3 patients after laparoscopic or surgical removal of the masses.

A morphologic evaluation was performed according to the International Ovarian Tumor Analysis Group (IOTA) recommendations for the following parameters: wall thickness, septation, papillary projections, presence and echogenicity of solid areas, presence of mixed component, cystic component, and presence of ascites and intra-abdominal metastases (peritoneal deposits, liver metastasis, and malignant abdominal lymphadenopathy) was also recorded. Pattern recognition analysis was also used for ovarian masses.

Statistical analysis:

The collected data was coded, tabulated, and statistically analyzed using IBM SPSS statistics (Statistical Package for Social Sciences) software version 22.0, IBM Corp., Chicago, USA, 2013 and Microsoft Office Excel 2007.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 62511
    • Beni-suef university Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

women with pelvic pain due to accidently discovered adnexal mass

Description

Inclusion Criteria:

• Females complaining of pelvic pain due to adnexal mass

Exclusion Criteria:

• Presence of Sure signs of malignancy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Gynecologic Imaging-Reporting and Data System (GI-RADS)	is a reporting system that was created for reporting the findings in adnexal masses based on transvaginal ultrasonography.	1 month from admission to ultrasound investigation and operation and finally histopathology report

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Investigators: Principal Investigator: Sara S Sara Salem, Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): January 4, 2023
• Study Completion (Actual): January 30, 2023

Study Registration Dates

• First Submitted: May 3, 2024
• First Submitted That Met QC Criteria: May 3, 2024
• First Posted (Actual): May 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 7, 2024
• Last Update Submitted That Met QC Criteria: May 3, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Ovarian cancer; Adnexal Masses; Gynecologic Imaging-Reporting and Data System
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms
• Other Study ID Numbers: GI-RADS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No