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The Use of International Ovarian Tumor Analysis and Assessment of Adnexal Neoplasia in Differentiating Malignant and Benign Adnexal Masses

NCT03442881 — Unknown, 80 participants, Cairo University

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The Use of International Ovarian Tumor Analysis and Assessment of Different Neoplasia in the Adnexa Model in Differentiating Malignant and Benign Adnexal Masses

RegistryNCT03442881
StatusUnknown
Study typeObservational
Enrollment80 (Estimated)
SponsorCairo University (Other)
ConditionsAdnexal Mass
InterventionsExcision of adnexal mass through laprotomy (Procedure)
Datesstart 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
Locations1 site in Egypt

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-Summary

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

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+Detailed description

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

+Arms and interventions

ArmTypeInterventionsDescription
benign adnexal massProcedure: Excision of adnexal mass through laprotomypathological examination of the specimen after excision reveals benign criteria
Malignant adnexal massProcedure: Excision of adnexal mass through laprotomypathological examination of the specimen after excision reveals malignant criteria
  • Excision of adnexal mass through laprotomy (Procedure): Through laparotomy incision, the adnexal mass will be excised

+Outcome measures

Primary outcomes

  • Nature of the mass [At time of surgery]: Benign or malignant criteria of the excised adnexal mass

+Eligibility

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.

+Locations (1)

FacilityCityCountryStatus
Kasr Alainy medical schoolCairoEgypt

+Investigators

My Notes