Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06403072 |
| Other study ID # |
GI-RADS |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
January 30, 2023 |
Study information
| Verified date |
May 2024 |
| Source |
Beni-Suef University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
prospective study was conducted and performed on 100 women with pelvic pain due to accidently
discovered adnexal mass
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.
