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临床试验/NCT02980185
NCT02980185已完成不适用

Laparoscopy for Primary Cytoreductive Surgery in Advanced Ovarian Cancer: a Prospective Validation and Comparison With Open Surgery.

Università degli Studi dell'Insubria1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2007年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
66
试验地点
1
主要终点
Residual tumor at the end of surgery (using the completeness of cytoreduction score)

研究概览

简要总结

To assess the feasibility, Residual Tumor, complication rate and survival of totally laparoscopic primary cytoreduction in carefully selected patients with Advanced Ovarian Cancer, compared with abdominal primary cytoreduction in a single-Institution, single-surgeon prospective series.

详细描述

All patients with presumed stage III-IV ovarian cancer and clinical conditions allowing aggressive surgery were candidate to possible primary cytoreduction with the aim of achieving residual tumor=0. A definite protocol was adopted: after radiological preoperative evaluation with PET-CT scan, all patients underwent laparoscopic evaluation with the Fagotti score. Once considered suitable for primary debulking surgery, the possibility of attempting laparoscopic cytoreduction was carefully evaluated using strict selection criteria; patients were divided in two groups, based on the type of surgical approach. At the end of laparoscopic primary cytoreduction, a ultra-low pubic minilaparotomy was performed to extract surgical specimens and to perform laparoscopic hand-assisted exploration of the abdominal organs, in order to ensure complete excision of the disease. Surgical data, optimal cytoreduction (defined as residual tumor=0) rates and survival outcomes were investigated.

研究设计

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

入排标准

性别
Female
接受健康志愿者

入选标准

  • Primary Ovarian cancer
  • Epithelial histotype
  • Stage III-IV disease

排除标准

  • Anesthesiological contraindication to primary cytoreduction
  • Extension of disease contraindicating primary cytoreduction

结局指标

主要结局

Residual tumor at the end of surgery (using the completeness of cytoreduction score)

时间窗: June 2007 - July 2015

次要结局

  • Overall Survival(June 2007 - July 2016)
  • Disease-free Survival(June 2007 - July 2016)

研究者

发起方
Università degli Studi dell'Insubria
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Uccella

Doctor

Università degli Studi dell'Insubria

研究点 (1)

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