NCT04709055尚未招募不适用
Implementation of coMplex PeRi-OperatiVe intervEntion in olDer Patients With Cancer : a Multicenter Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 630
- 试验地点
- 2
- 主要终点
- Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo
研究概览
简要总结
Incidence of digestive cancers increase and half of new cases will be people of 75 years or more in 2050. Surgery is one of the main treatment's strategy but post-operative morbi-mortality increases with age. Pre-operative Geriatric Assessment enable to identify frail or vulnerable patients at risk of post-operative complications.
The coordinating team postulate that a geriatric and surgical co-management with a combination of several targeted geriatric interventions with usual post-operative care could improve the post-operative care and decrease the risk of morbi-mortality in older patients with digestive cancers.
详细描述
Multicenter Randomized Clinical Trial in 2 parallel-groups with masked adjudication of main endpoint
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 75 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 75 years or more
- •Gastric, colo-rectal, pancreatic cancer or hepatic metastasis needed a surgical treatment
- •Health Insurance
- •At risk of post-operative complication through Surgical Risk Calculator (>25%) or surgeon judgment.
- •Written consent
排除标准
- •Surgery in emergency
结局指标
主要结局
Percentage of patients with postoperative complications of grade II or higher in the Clavien-Dindo
时间窗: at 30 days after surgery
次要结局
- Social Status(at Day 14 and Day 30 after surgery)
- Percentage of patients with postoperative complications of each grade in the Clavien-Dindo(at Day 14 and Day 30)
- Mini-Geriatric Depressive Scale(at Day 14 and Day 30 after surgery)
- Updated Charlson Comorbidity Index(at Day 14 and Day 30 after surgery)
- Body mass index(at Day 14 and Day 30 after surgery)
- Mini cognitive scale(at Day 14 and Day 30 after surgery)
- Instrumental Activities of Daily Living Scale(at Day 14 and Day 30 after surgery)
- Timed Up and Go(at Day 14 and Day 30 after surgery)
- Gait speed(at Day 14 and Day 30 after surgery)
- Percentage of patients with each complication among a prespecified list of complication(at Day 14 and Day 30)
- Activities of Daily Living Scale(at Day 14 and Day 30 after surgery)
- Mini Nutritional Assessment-Short Form(at Day 14 and Day 30 after surgery)
- Percentage of patients with cancelled surgeries(at Day 0 to Day 8)
- Length of stay to geriatric unit, intensive care unit, rehabilitation unit or other departement.(at Day 14, Day 30 and Day 90 after surgery)
- Overall survival(at Day 30 and Day 90 after surgery)
- Percentage of patients with postponed surgeries(at Day 0 to Day 8)
- Time of onset of each post-operative complication(at Day 14, Day 30 and Day 90 after surgery)
- Percentage of patients transfered to geriatric unit, intensive care unit, rehabilitation unit or other departement.(at Day 14, Day 30 and Day 90 after surgery)
- Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - C30)(at Day 30 and Day 90 after surgery)
- Patient and professionals experience (ancillary study using semi-directive interviews)(at Day 30 after surgery)
- Percentage of patients with complete intervention in the experimental arm(at Day 0 to Day 8)
- Percentage of patients returned at home or institutionalization(at Day 14, Day 30 and Day 90 after surgery)
- Quality of life (European Organisation for Research and Treatment of Cancer - Quality of life - ELD14)(at Day 30 and Day 90 after surgery)
- Length of hospitalizations(at Day 14 after surgery)
- Autonomy (Activities of Daily Living scale)(at Day 14 , Day 30 and Day 90 after surgery)
研究者
研究点 (2)
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