Gynecology
Conditions
Brief summary
To compare between the efficacy of IOTA simple rules and pattern recognition method in the differentiating between benign and malignant adnexal masses
Interventions
Sponsors
Woman's Health University Hospital, Egypt
Study design
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Level-II Transvaginal ultrasonography will be done by the principle investigator (who is unaware about the recognition pattern method) to confirm the presence of the ovarian mass and measure its size and to apply the IOTA simple rules on it (complimentary transabdominal ultrasound might be done for huge pelvi-abdominal masses originating from the ovary). Level-III ultrasound will be done by expert ultrasound operator (who is blinded to the results of IOTA simple rules assessment of the examined mass) to classify the mass (either benign or malignant) using the pattern recognition method.
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Ovarian mass more than 5 cm in size (confirmed by transvaginal or transabdominal ultrasonography in gynecology clinic) * The patient is candidate for abdominal exploration for ovarian Cystectomy or oophorectomy.
Exclusion criteria
* Complicated ovarian masses. * Unfit for surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| comparing the sensitivity of the IOTA versus the Pattern recognition in diagnosing the different types of ovarian masses | 12 month |
Countries
Egypt
Outcome results
None listed