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临床试验/NCT04659148
NCT04659148Unknown不适用

Surgical and Oncological Outcomes in Patients With Ulcerative Colitis Associated Rectal Cancer: a Retrospective Study

Istituto Clinico Humanitas2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
2
主要终点
Oncological outcome

研究概览

简要总结

This is a retrospective observational study to investigate the short-term surgical outcomes, and long-term oncological outcomes of patients diagnosed with Ulcerative colitis and rectal cancer.

详细描述

Inflammatory Bowel Disease (IBD) is a risk factor for the development of colorectal cancer (CRC). Despite improved targeted screening and timely prophylactic resection, up to 15% of all IBD-related mortality can be attributed to CRC.

Previous reports suggest that IBD patients present with CRC at an earlier age and with more advanced disease than those with sporadic CRC. The literature is limited, however, with respect to colitis-associated rectal cancer (CARC), which has unique considerations such as surgical approach and the use of neoadjuvant therapy. Although total proctocolectomy is generally the procedure of choice for those with CARC, recent reports reported acceptable oncological outcomes after ileal pouch-anal anastomosis (IPAA) and ileorectal anastomosis (IRA).

The impact of the type of surgical procedure on the oncologic outcome in patients with CARC is not well defined.

The aim of this study is to investigate short-term surgical outcomes (postoperative complications at 30 days after surgery) and long-term oncological outcomes (disease-free survival) of CARC patients undergoing different surgical approaches.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

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

入选标准

  • Patients diagnosed with Ulcerative Colitis;
  • Patients diagnosed with rectal cancer (within 15 cm from the anal verge);
  • Patients who underwent surgery for rectal cancer between January 2004 and January 2020;
  • All type of surgery will be included;
  • Surgery in elective and emergency settings.

排除标准

  • Patients aged<18 years;
  • Patients with a diagnosis of undetermined colitis;
  • Insufficient follow-up data.

结局指标

主要结局

Oncological outcome

时间窗: 5 years after surgery

Disease-free survival

Surgical outcome

时间窗: 30 days after surgery

30 days postoperative complications

次要结局

未报告次要终点

研究者

发起方
Istituto Clinico Humanitas
申办方类型
Other
责任方
Sponsor

研究点 (2)

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