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Trial Title:
Doppler Ultrasound and CT Versus Laparoscopy in Assessment of Ovarian Malignancy
NCT ID:
NCT06109545
Condition:
Ovarian Cancer
Conditions: Official terms:
Ovarian Neoplasms
Conditions: Keywords:
Ovarian cancer, Doppler, CT, Laparoscopy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Procedure
Intervention name:
Laparoscopy
Description:
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
Arm group label:
Women with suspicion of ovarian malignancy
Other name:
Laparoscopic Fagotti scoring
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
Criteria for eligibility:
Study pop:
Women with suspicious ovarian malignancy
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Locations:
Facility:
Name:
Mansoura University Hospital
Address:
City:
Mansoura
Country:
Egypt
Status:
Recruiting
Contact:
Last name:
Sarah Madany, MSc
Phone:
+201027991297
Email:
sarahmadany20@gmail.com
Start date:
June 24, 2023
Completion date:
June 1, 2025
Lead sponsor:
Agency:
Mansoura University
Agency class:
Other
Source:
Mansoura University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06109545
