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临床试验/NCT04665635
NCT04665635招募中不适用

Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)

Cukurova University3 个研究点 分布在 2 个国家目标入组 120 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
3
主要终点
Local pelvic recurrence

研究概览

简要总结

Ovarian cancer is the most common cause of death in gynecological cancer. Approximately 75% of epithelial ovarian cancers are detected at an advanced stage. Metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface. Metastasis mostly occurs in the peritoneum, omentum, and intestines. The rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood.

Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy. Surgery is the basis of the treatment, and the main goal is to achieve no residual visible tumor (complete cytoreduction: R0). The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team. Multiple surgical procedures (total hysterectomy, bilateral salpingo-oophorectomy, total omentectomy, peritonectomy, retroperitoneal lymphadenectomies such as pelvic and paraaortic, bowel resections, splenectomy, distal pancreatectomy, various resections related to the bladder, liver, stomach, and diaphragm) may be required to achieve complete or optimal cytoreduction.

In the involvement of the rectosigmoid colon, primarily the serosa, then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread, and therefore most of the involvement is observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed. There are advantages and disadvantages of each method in terms of morbidity. Although there are retrospective studies evaluating recurrence and survival between both methods, as far as investigators know, no randomized prospective studies have been conducted comparing these two methods. The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Epithelial ovarian cancer
  • Negative colonoscopy ( no mucosal involvement)
  • Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration

排除标准

  • Nonepithelial ovarian cancers
  • Rectosigmoid mucosal infiltration
  • Total or subtotal colectomy necessitating large bowel infiltrations

结局指标

主要结局

Local pelvic recurrence

时间窗: 0-60 months.

Only the pelvic recurrences determined after the last chemotherapy cycle.

Recurrence-free survival

时间窗: 0-60 months.

The time from the last chemotherapy cycle to determination of any recurrence in any location.

次要结局

  • Health related Quality of life(0-24 months.)
  • Overall survival(0-100 months.)
  • Cancer specific survival(0-100 months)
  • Surgery related morbidities(90 days.)

研究者

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

Ghanim Khatib

Associate professor, MD

Cukurova University

研究点 (3)

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