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临床试验/NCT04759638
NCT04759638已完成不适用

Body Mass Index Role in the Oncological Outcome of Locally Advanced Rectal Cancer: The Two BMI Extremes as Comparative Groups, A Retrospective Study

King Hussein Cancer Center1 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2017年3月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
1
主要终点
Disease-Free Survival (DFS)

研究概览

简要总结

There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.

The obesity paradox appears to exist in rectal cancer patients treated with nCRT and surgery, as it was associated with significantly higher rates of pathological complete response and R0 resection.

Underweight patients were at higher risk for anastomotic leak and R1 resection.

详细描述

Background:

Obesity and underweight are associated with increased risk of postoperative morbidity in colorectal cancer patients undergoing surgery. There is a controversy regarding the effect of the two Body Mass Index (BMI) extremes on the oncological outcome of rectal cancer.

Objective:

The aim of this study was to evaluate the effect of BMI on short- and long-term oncological outcomes as well as postoperative complications in rectal cancer patients who received neoadjuvant chemoradiotherapy (nCRT) followed by surgery.

Setting:

研究设计

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

入排标准

接受健康志愿者

入选标准

  • Patients who underwent rectal surgery at King Hussein Cancer Center (KHCC) from 2006 to 2018 were identified. Those with locally advanced rectal cancer (stages II and III) who underwent nCRT followed by surgery with curative intent were included.

排除标准

  • Patients with early rectal cancer (stage I) who did not require nCRT and those who underwent rectal surgery as part of a staged or simultaneous approach for metastatic disease (stage IV) were excluded.

结局指标

主要结局

Disease-Free Survival (DFS)

时间窗: 5 yers

Disease-free survival (DFS) was defined as the time from surgical resection to disease recurrence (including loco-regional failure or metastases) or death of any cause

Overall Survival (OS)

时间窗: 5 years

Overall survival (OS) was defined as the time interval from surgical resection to either death from any cause or last follow up

次要结局

  • Pathological Complete Response (CR)(5 years)

研究者

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

Mahmoud Al-Masri

Chairman, Department of Surgery

King Hussein Cancer Center

研究点 (1)

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