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临床试验/NCT04349384
NCT04349384已完成不适用

Audit of the Quality of Surgical Treatment of Colorectal Cancer

Institut National d'Oncologie, Morocco1 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
136
试验地点
1
主要终点
Retrieved lymph nodes

研究概览

简要总结

The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat during a two-years period. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.

详细描述

Quality improvement initiatives and in particular the accreditation procedure raises the inevitable question of measuring quality in health. Several surgical audits have been carried out internationally, showing the importance of collecting reliable and valid information on the quality of care. This approach allows an evaluation and improvement of the quality of care provided, significantly correlated to a direct impact on morbidity and mortality. In addition, it provides valuable information for evidence-based medicine research as it provides data on patients often excluded from therapeutic trials.

Colorectal cancer is the first digestive cancer and the third cancer worldwide. Surgical resection is the main curative treatment. Surgical quality is associated with better short and long term results. Quality improvement measures, with the goal to improve surgical care of colorectal cancer, are becoming a standard worldwide.

The aim of this project is to audit the surgical care in patients treated for colorectal adenocarcinoma. This study focused on collecting data from all consecutive cases of colon and rectal adenocarcinoma operated at the National Institute of Oncology in Rabat. Using standardized forms, the investigators collected data relating to each stage of treatment: pre-therapeutic, surgical and post-operative in order to measure the quality of the surgical care delivered. These results were compared to established benchmarks and to similar audit studies carried out in other countries around the world.

研究设计

研究类型
Observational
观察模型
Cohort
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 with histologically proven colorectal adenocarcinoma who underwent surgical resection with curative intent between 1 January 2018 and 31 December 2019.

排除标准

  • Colon or rectal resections for other histologic types than adenocarcinoma.
  • Palliative intent surgery.

结局指标

主要结局

Retrieved lymph nodes

时间窗: 1 month after surgery

Number patients with retrieved lymph nodes after colon resection above 12

Morbidity

时间窗: 90 days after surgery

Morbidity assessed using using the Clavien-Dindo grading system at discharge and at 90 days after surgical resection for colorectal adenocarcinoma

Positive circumferential margin

时间窗: 1 month after surgery

The rate of patients with circumferential margin \< 1 mm on surgical specimen of rectal resection for rectal adenocarcinoma.

次要结局

  • MRI for rectal adenocarcinoma(7 days after surgery)
  • Anastomotic leakage(90 days after surgery)
  • Readmission(90 days after surgery)
  • Pre-operative CT-scan(7 days after surgery)
  • Multidisciplinary team meeting(7 days after surgery)

研究者

发起方
Institut National d'Oncologie, Morocco
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Anass Majbar

Professor of surgery

Institut National d'Oncologie, Morocco

研究点 (1)

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