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Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

NCT ID: NCT06109545

Last Updated: 2023-10-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

95 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-24

Study Completion Date

2025-06-01

Brief Summary

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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

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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

Conditions

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Ovarian Cancer

Keywords

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Ovarian cancer, Doppler, CT, Laparoscopy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Women with suspicion of ovarian malignancy

Women with suspicion of ovarian malignancy depending on ultrasound, CT, MRI and CA 125

Laparoscopy

Intervention Type PROCEDURE

Patients included in this study will have diagnostic laparoscopy type WOLF done after checking all above ultrasound parameters of malignant tumor. This procedure will be done under general anathesia then a verses needle will be used at umbilicus or at palmer point if the mass is large or in cases of umbilical hernia or previous abdominal or pelvic surgery, then Fagotti criteria will be assessed

Interventions

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Laparoscopy

Patients included in this study will have diagnostic laparoscopy type WOLF done after checking all above ultrasound parameters of malignant tumor. This procedure will be done under general anathesia then a verses needle will be used at umbilicus or at palmer point if the mass is large or in cases of umbilical hernia or previous abdominal or pelvic surgery, then Fagotti criteria will be assessed

Intervention Type PROCEDURE

Other Intervention Names

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Laparoscopic Fagotti scoring

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Madany, MSc

Role: PRINCIPAL_INVESTIGATOR

Mansoura University

Locations

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Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Sarah Madany, MSc

Role: CONTACT

Phone: +201027991297

Email: [email protected]

Facility Contacts

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Sarah Madany, MSc

Role: primary

Other Identifiers

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SM.MD

Identifier Type: -

Identifier Source: org_study_id