ORADS in evaluation of adnexal masses
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 324
- Locations
- 1
- Primary Endpoint
- Accuracy of ORADS in differentiating benign and malignant adnexal masses
Study Overview
Brief Summary
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).
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 12.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(1)women with adnexal lesion not removed surgically or not evaluated histopathologically.
- •(2) women on conservative management and follow up.
Outcomes
Primary Outcomes
Accuracy of ORADS in differentiating benign and malignant adnexal masses
Time Frame: 1 year 4 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Ayushi Raj
KMC, Manipal
