Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

Recruiting

• Conditions: Ovarian Cancer
• Interventions: Procedure: Laparoscopy

• Registration Number: NCT06109545
• Lead Sponsor: Mansoura University

Brief Summary

The aim of this study is to assess validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Detailed Description

The aim of this study is to asses validation of ultrasound (± Doppler) parameters in the diagnosis of suspicious ovarian malignant tumors and laparoscopic assessment of these findings according to Fagotti score evaluation of suspicious malignant tumors

Study Timeline

• Study Start: 2023-06-24
• Status Verified: 2023-10
• Study First Submitted: 2023-10-25
• Study First Submitted QC: 2023-10-25
• Last Update Submitted: 2023-10-25
• Study First Posted: 2023-10-31
• Last Update Posted: 2023-10-31
• Primary Completion: 2025-06-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 95

Inclusion Criteria

1. all patients with clinical or radiological suspicion of ovarian cancer.
2. at least one of clinical presentation of suspected or advanced ovarian cancer and performed ultrasound or CT or MRI that detect a pelvic mass and CA125 is more than 200 UL/ML.
3. patients with eastern Cooperative Oncology Group status from 0 to 3.

Exclusion Criteria

1. the women outside the age group in our study.
2. any known malignancy at other sites.
3. uncompliant patients who have severed uncontrolled infection or any other medical problem.
4. any previous major surgery.
5. patients who refuse to give an informed consent to do laparoscopy.
6. pregnancy and its complications.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women with suspicion of ovarian malignancy	Laparoscopy	Women with suspicion of ovarian malignancy depending on ultrasound, CT, MRI and CA 125

Primary Outcome Measures

Name	Time	Method
Fagotti score	Al time of laparoscopy	Laparoscopic staging of suspicious ovarian mass

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Dakahlia, Egypt