The Use of International Ovarian Tumor Analysis and Assessment of Different Neoplasia in the Adnexa Model in Differentiating Malignant and Benign Adnexal Masses
| Registry | NCT03442881 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 80 (Estimated) |
| Sponsor | Cairo University (Other) |
| Conditions | Adnexal Mass |
| Interventions | Excision of adnexal mass through laprotomy (Procedure) |
| Dates | start 2018-02-01 (estimated), primary completion 2018-12-01 (estimated), completion 2018-12-01 (estimated), first posted 2018-02-22, last updated 2018-02-22 |
| Locations | 1 site in Egypt |
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All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen
All participants will be subjected to Serum measurements of CA-125 by the immunoradiometric assay, Ultrasound evaluation of the Adnexal masses which is described according to origin (ovarian/extraovarian); position (right/left/bilateral); number of lesions; type of lesions (unilocular/multilocular); size in three dimensions (longitudinal, anteroposterior and transverse diameters); intracystic fluid echogenicity; number of loculations; presence and size of septations (only thickest one of septations is considered); presence, number and size of solid papillary projections (largest thickness is considered); presence and size of the largest solid component (three diameters); presence and measurement of fluid volume in the posterior cul-de-sac and presence and location of lesions suggestive of metastases. Then surgical intervention will be done with pathological examination of the specimen
| Arm | Type | Interventions | Description |
|---|---|---|---|
| benign adnexal mass | Procedure: Excision of adnexal mass through laprotomy | pathological examination of the specimen after excision reveals benign criteria | |
| Malignant adnexal mass | Procedure: Excision of adnexal mass through laprotomy | pathological examination of the specimen after excision reveals malignant criteria |
Sex: Female, ages: 15 Years to 70 Years
Inclusion Criteria: * Women with clinically and sonographically diagnosed adenxal mass more than 5 cm in diameter. 2. Patients who will undergo surgical intervention . 3. Patients are recruited regardless of age, parity and complaint Exclusion Criteria: * Patients treated with conservative management. 2. Patients known to be pregnant.
| Facility | City | Country | Status |
|---|---|---|---|
| Kasr Alainy medical school | Cairo | Egypt |