Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

• Sponsor: Mansoura University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06109545
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Anticipated Duration (Months): 23.3
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Ovarian Cancer	Procedure: Laparoscopy

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 Design

• Study Type: Observational
• Anticipated Enrollment: 95 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Validation of Doppler Ultrasound, CT Parameters Versus Laparoscopic Scoring in Assessment of Suspicious Ovarian Malignancy
• Actual Study Start Date: Jun 24, 2023
• Anticipated Primary Completion Date: Jun 1, 2025
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm

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

Outcome Measures

Primary Outcome Measures

1. Fagotti score [Al time of laparoscopy]

   Laparoscopic staging of suspicious ovarian mass

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Female

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura University Hospital	Mansoura	Dakahlia	Egypt

Sponsors and Collaborators

• Mansoura University

Investigators

• Principal Investigator: Sarah Madany, MSc, Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mansoura University
• ClinicalTrials.gov Identifier: NCT06109545
• Other Study ID Numbers: SM.MD
• First Posted: Oct 31, 2023
• Last Update Posted: Oct 31, 2023
• Last Verified: Oct 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Mansoura University: Ovarian cancer, Doppler, CT, Laparoscopy
• Additional relevant MeSH terms: Ovarian Neoplasms

Study Results

No Results Posted as of Oct 31, 2023