Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy

NCT06109545 | Unknown

• 1 other identifier: SM.MD
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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

Conditions

Ovarian Cancer

Keywords

Ovarian cancer, Doppler, CT, Laparoscopy

Outcome Measures

Primary Outcomes (1)

• Fagotti score

  Laparoscopic staging of suspicious ovarian mass

  Al time of laparoscopy

Study Arms (1)

Women with suspicion of ovarian malignancy

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

Procedure: Laparoscopy

Interventions

Laparoscopy 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

Also known as: Laparoscopic Fagotti scoring

Women with suspicion of ovarian malignancy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with suspicious ovarian malignancy

You may qualify if:

• all patients with clinical or radiological suspicion of ovarian cancer.
• 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.
• patients with eastern Cooperative Oncology Group status from 0 to 3.

You may not qualify if:

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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Dakahlia Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Sarah Madany, MSc

  Mansoura University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Madany, MSc

CONTACT

+201027991297; sarahmadany20@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: October 31, 2023
• Study Start: June 24, 2023
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: October 31, 2023

Record last verified: 2023-10

Locations

EG (1)