GOSAFE Study Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery An International Prospective Audit to Evaluate Postoperative Functional Outcomes and Quality of Life After Cancer Surgery in Geriatric Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,004
- 试验地点
- 28
- 主要终点
- Quality of Life (QoL)
研究概览
简要总结
Multicenter, international, prospective, observational study, designed to evaluate the postoperative results in terms of quality of life and functional recovery of elderly patients after major cancer surgery.
The global expected duration of the study is 3 years, during which cancer patients over 70 years old undergoing major surgery will be evaluated before and after the surgical intervention, at 30 days, 3- and 6-months follow-up. The study is non-for-profit. Given the observational nature of the study, the original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion. Inclusion in the study does not imply any deviation from the current standard of practice, and no change is expected to the perioperative treatment at any point. Patients will be only asked to complete simple screening/assessment tests.
详细描述
GOSAFE study is a prospective international collaborative high-quality registry aiming to gain knowledge about postoperative outcomes in older cancer patients with a particular emphasis on QoL and FR. The target is to obtain meaningful data to assist clinicians in tailoring the care, avoiding under/over-treatment, providing robust data to identify new strategies to improve functional outcomes in older cancer patients.
Recruiting centers will collect data prospectively. Recruited patients will be followed for 6 months after their surgery.
The original treatment plan, as designed by each individual recruiting centre, will not be altered or affected by the study inclusion.
Centers should ensure that they would make every possible effort to include all consecutive eligible patients during the study period and provide completeness of data entry to ensure a 'real-life' study.
Patients both gender, both gender, aged ≥70, affected by solid malignancy undergoing elective major surgical procedures with curative or palliative intent are eligible.
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
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All consecutive patients, both gender, aged ≥70
- •Patients affected by solid malignancy
- •Patients undergoing elective major surgical procedures with curative or palliative intent (all major procedures including any resection, for any cancer, via any operative approach, open, laparoscopic, robotic, etc...)
- •Informed consent obtainment
排除标准
- •Patients undergoing emergent/urgent surgical procedures
- •Planned hospital stay less than 48 hours
结局指标
主要结局
Quality of Life (QoL)
时间窗: 6 months
To evaluate the effects of surgery on patients' life perception by comparing pre- and post-operative QoL in elderly patients undergoing major surgery for solid malignancies using a self-reported Quality of Life assessment tool
次要结局
- Functional recovery (FR)(6 months)
- Morbidity(6 months)
- Mortality(6 months)
- Prognostic factors(6 months)
研究者
AUSL ROMAGNA
Azienda USL della Romagna
AUSL Romagna Rimini