| CTRI Number |
CTRI/2024/01/062051 [Registered on: 30/01/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Evaluation of Adnexal masses |
|
Scientific Title of Study
|
ORADS in evaluation of adnexal masses |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Raj |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Department of Obstetrics and Gynecology, KH, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
ayushiraj2904@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr. Shyamala G |
| Designation |
Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of Obstetrics and Gynecology, KH, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
0 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr. Shyamala G |
| Designation |
Professor |
| Affiliation |
KMC, Manipal |
| Address |
Department of Obstetrics and Gynecology, KH, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
0 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Hospital, Manipal |
|
|
Primary Sponsor
|
| Name |
Dr Ayushi Raj |
| Address |
Department of Obstetrics and Gynecology, KMC Manipal |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ayushi Raj |
Kasturba Hospital, Manipal |
Department of Obstetrics and Gynecology, KH, Manipal Udupi KARNATAKA |
9630686086
ayushiraj2904@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N832||Other and unspecified ovarian cysts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Female |
| Details |
(1) presence of at least one adnexal lesion detected by transvaginal or transabdominal ultrasonography like: Simple ovarian cyst, ectopic, ovarian tumors, tubal or broad ligament neoplasms etc.
(2) lesion removed surgically and evaluated histopathologically.
(3) time interval between ultrasound detection and surgery not exceeding 30 days.
|
|
| ExclusionCriteria |
| Details |
(1)women with adnexal lesion not removed surgically or not evaluated histopathologically.
(2) women on conservative management and follow up.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Accuracy of ORADS in differentiating benign and malignant adnexal masses |
1 year 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="324" Sample Size from India="324"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The
study included 150 women with adnexal lesion who underwent surgical
intervention. The ultrasound findings were recorded as per O’RADS
classification and O’RADS categories were tested for accuracy against
histopathology.
·
The
study cohort had women aged 12- 72years with the mean age of 35.89 years.
·
63
(42%) of women had normal BMI and 87 (58%) women had BMI >25 kg/m².
·
There
were 83 (55.3%) participants who were nulliparous and 67 (44.7%) were
multiparous.
·
Nearly
one-third {43 (28.7%)} of the participants had history of infertility. 28
(18.7%) women were known case of endometriosis and 22 (14.7%) were
postmenopausal.
·
There
were 50 (33.3%) women who were co morbid and 5 (3.3%) had family history of
cancer.
·
Out
of 150, 131 (87.3%) were non-malignant and 19 were malignant (12.7%) which
included 6 borderline tumours.
·
O’RADS
category 2 (benign) had 74 cases and 100% were benign, category 3 (low risk)
had 32 cases in which only 1 (3.1%) was malignant, category 4 (intermediate
risk) had 38 cases in which 12 (31.6%) were malignant and category 5 had 6
cases and 100% were malignant.
·
Among
the ultrasound parameters, features significantly associated with malignancy were
colour score, ascites, solid areas, inner margins and number of papillary
projections.
·
O’RADS
4 had the highest false positive cases among all categories. Ultrasound
parameters resulting in maximum false positives were number of locule, solid
areas and number of papillary projections.
·
Taking
O’RADS 4 as the appropriate cutoff for malignancy, the diagnostic accuracy of
O’RADS was 82.7% with sensitivity of 94.7% and specificity of 80.9%.
·
Statistically
significant relationship was seen between O’RADS risk of malignancy and final
impression. (p <0.001). |