Ignite Creation Date:
2024-05-11 @ 8:31 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06403072
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2024-05-03
Brief Title:
GI-RADS in Preoperative Evaluation of Adnexal Masses
Sponsor:
Beni-Suef University
Organization:
Beni-Suef University
Study Overview
Official Title:
Diagnostic Performance of the Gynecologic Imaging-Reporting and Data System GI-RADS in Preoperative Evaluation of Adnexal Masses
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 patients 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 andor 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 220 IBM Corp Chicago USA 2013 and Microsoft Office Excel 2007
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 patients 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 andor 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 220 IBM Corp Chicago USA 2013 and Microsoft Office Excel 2007
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None