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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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).


 
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