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临床试验/NCT02856841
NCT02856841已完成不适用

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

Cairo University0 个研究点目标入组 44 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
44
主要终点
feasibility of optimum cytoreduction

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • malignant epithelial ovarian tumor (EOC)
  • FIGO stage II, III, and IV.

排除标准

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

结局指标

主要结局

feasibility of optimum cytoreduction

时间窗: 1 year after surgery

ability to remove all gross lesions from the tumor intraoperatively and leaving no ovarian lesion seen by naked eye of the expert surgeon

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Maged

Assistant professor

Cairo University

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