Clinical trial NCT02856841: The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Ovarian Cancer
Official title: The Preoperative Predictors of Optimal Cytoreductive Surgery in Women With Advanced Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: epithelial ovarian cancer
optimum cytoreduction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 44
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 44 patients were enrolled in this study as they had malignant epithelial ovarian tumor (EOC), FIGO stage II, III, and IV.

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.

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

Primary outcomes:
measure: feasibility of optimum cytoreduction
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Kasr Alainy medical school
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References: