Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

October 25, 2023 updated by: Mansoura University

Validation of Doppler Ultrasound, CT Parameters Versus Laparoscopic Scoring in Assessment of Suspicious Ovarian Malignancy

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

95

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt
        • Recruiting
        • Mansoura University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Women with suspicious ovarian malignancy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Women with suspicion of ovarian malignancy
Women with suspicion of ovarian malignancy depending on ultrasound, CT, MRI and CA 125
Procedure: 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
Other Names:
  • Laparoscopic Fagotti scoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fagotti score
Time Frame: Al time of laparoscopy
Laparoscopic staging of suspicious ovarian mass
Al time of laparoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Principal Investigator: Sarah Madany, MSc, Mansoura University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 24, 2023

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

October 31, 2023

Last Update Submitted That Met QC Criteria

October 25, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM.MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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