Benchmarking Trial Between France and Australia Comparing Management of Primary Rectal Cancer Beyond TME (Total Mesorectum Excision) and Locally Recurrent Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 165
- 试验地点
- 12
- 主要终点
- Clinical resection rates in both countries
研究概览
简要总结
The incidence of rectal cancers is at 15,000 new cases per year in France of which 10 to 15% are locally advanced (T4bNxM0) at the moment of diagnosis. The rate of invaded resection margins (R1) for these locally advanced and fixed rectal tumours varies from 10 to 20%. The invasion of the resection margins triples the risk of local recurrence. In the absence of surgical treatment, the 5-year survival rate for patients having had pelvic recurrence of rectal cancer is lower than 4% whereas it varies from 35 to 40% in cases of curative resection. The care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer constitutes, therefore, in the absence of recommendation, a difficult therapeutic problem with great variability in the methods of care and management around the world. These variations in practice can be explained by structural and organizational differences, as well as cultural dissimilarities. With regards to the organization of its healthcare system, Australia is shown to be a leader as regards the care and management of locally advanced and fixed rectal tumours and pelvic recurrence of rectal cancer.
详细描述
This research project rests on the comparison between two contrasting countries with regards to the care management of PRC-bTME (Primary rectal cancer beyond total mesorectum excision planes) and LRRC (Locally recurrent rectal cancer), France and Australia. Regarding its healthcare system for patients with PRC-bTME and LRRC, Australia equipped itself with a veritable policy of centralisation and clinical pathway, appearing as an international referent country in this surgical field.
The main hypotheses of research are that these differences rest on individual and collective representation of disease, organisations, structures, clinical pathway and care management.
Benchmarking of clinical practices is a process that consists of a structured comparison and the sharing of good practices of clinical care; it is based on a quality of care assessment and allows to fit into an approach of continuous improvement of this quality of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients operable and/or capable of receiving a radiotherapy and/or a chemotherapy
- •Patients in care in the French and Australian centres participating in the study
排除标准
- •Patients suffering from primitive rectal cancer at a stage inferior to T4b
- •Patients suffering from primitive locally-advanced metastatic rectal cancer (T4NxM1)
- •Patients suffering from recurrence of metastatic rectal cancer
- •Patients having been refused a surgical procedure because of one or multiple comorbidities
结局指标
主要结局
Clinical resection rates in both countries
时间窗: 12 months
Expressed as a percentage and corresponding to the ratio between the number of patients operated and the number of patients discussed in colorectal MDT meetings for PRC-bTME and LRRC. These rates will be expressed separately in each country and compared.
次要结局
- Disease Free Survival(12 months)
- R0 resection rate(12 months)
- Concordance rate of operative decisions between France and Australia(6 months, 12 months)
- Overall Survival(12 months)
- Analyses of semi-structured interviews(12 months)
- Post-operative morbidity and mortality rates(30 days)
- Quality of life questionnaire(6 months, 12 months)
- Stress level score(6 months, 12 months)