The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Ovarian Cancer

NCT ID: NCT02856841

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 44 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-06-30

Brief Summary

44 patients were enrolled in this study as they had malignant epithelial ovarian tumor.Pre-operative staging was assessed by CT scan based on FIGO classification and compared to the standard laparotomy surgical staging. Maximal surgical effort for Optimum cytoreduction was achieved and the risk factors for sub-optimal cytoreduction were studied

Detailed Description

Each patient was subjected to comprehensive medical history taking and careful clinical examination, laboratory investigations (CA-125) and imaging (abdomino-pelvic CT scan). Patients with suspected bowel involvement were subjected for colonoscopy.

Pre-operative Abdomino-pelvic CT scans:

Preoperative CT scans were performed with a high-speed scanner after the oral and intravenous administration of contrast medium. The hard copy images were reviewed by consultant radiologists for assessment of the findings suggestive of malignant adnexal mass which are bilateral lesions, thick septa, enhancing solid components, ascites, and peritoneal deposits .

Pre-operative staging of cancer ovary was assessed by CT scan based on FIGO classification:

1. Stage II: tumor involving ovaries with pelvic extension +/- ascites.

2. Stage III: tumor involving ovaries with peritoneal implant outside pelvis +/- ascites.

3. Stage IV: tumor involving ovaries with parenchymal liver metastasis and/or pleural effusion.

Surgical treatment:

All patients underwent standard longitudinal laparotomy, intensive surgical staging and maximal surgical effort for Optimum cytoreduction which was included all of the following (total abdominal hysterectomy, bilateral salpingo-oophorectomy, infracolic-omentectomy, appendectomy, surgical removal of all tumor masses, intestinal resections if required).Achievement of no gross residual disease has been attempted in all cases. Finally, patients were divided into two groups:

• Suboptimal cytoreduction group with any gross tumor residue.
• Optimal cytoreduction group without any gross tumor residue.

Surgical risk factors for optimum cytoreduction:

• Parenchymal liver involvement.
• Omental involvement.
• Bowel involvement.
• Para aortic lymph node involvement.
• Peritoneal carcinomatosis: it is defined as disease > 4 mm involving 2 or more of the following areas; lateral colic gutters, anterior abdominal wall, diaphragm, and pelvic peritoneal reflections.
• Pelvic sidewall invasion: it is defined as presence of one or more of the following; tumor fixed to the pelvic bony wall, encasement of iliac vessels, and hydroureter.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

optimum cytoreduction

without any gross tumor residue after surgery

No interventions assigned to this group

Suboptimum cytoreduction

with any gross tumor residue after surgery

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• malignant epithelial ovarian tumor (EOC)

FIGO stage II, III, and IV.

Exclusion Criteria

• Patients with previous abdominal or pelvic major surgery, synchronous abdominal or pelvic pathology or medically unfit for surgery

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Maged

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahmed Maged, MD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy medical school

Other Identifiers

152

Identifier Type: -

Identifier Source: org_study_id