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(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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06403072
Enrollment
100
Registered
2024-05-07
Start date
2021-06-01
Completion date
2023-01-30
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian Cancer

Keywords

Gynecologic Imaging-Reporting and Data System, Adnexal Masses, Ovarian cancer

Brief summary

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

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.

Interventions

DIAGNOSTIC_TESTThe Gynecologic Imaging-Reporting and Data System (GI-RADS)

The Gynecologic Imaging-Reporting and Data System (GI-RADS) using ultrasound

Sponsors

Beni-Suef University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Females complaining of pelvic pain due to adnexal mass

Exclusion criteria

* Presence of Sure signs of malignancy

Design outcomes

Primary

MeasureTime frameDescription
The Gynecologic Imaging-Reporting and Data System (GI-RADS)1 month from admission to ultrasound investigation and operation and finally histopathology reportis a reporting system that was created for reporting the findings in adnexal masses based on transvaginal ultrasonography.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026