Geriatric Oncology Surgical Assessment and Functional rEcovery After Surgery (GOSAFE)
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
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.
研究概览
详细说明
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.
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.
For every eligible patient, demographic data will be collected at baseline followed by a fast preoperative functional assessment. Data regarding surgical procedures and perioperative measures will be collected. Complications will be reported and graded according to Clavien-Dindo Classification. Three- and six-month follow up data will be collected after surgery within a range of 2 weeks from the due date.
The Full Analysis Set (FAS) consists of all registered patients. The primary endpoint will be measured for all registered subjects who fulfill preoperative and postoperative EQ VAS. Demographic and baseline patient characteristics will be summarized for all patients in the FAS. Continuous-scaled variables (e.g., age) will be summarized with means, medians, standard deviations, quartiles, and minimum and maximum values. Categorical variables (e.g., sex) will be summarized using patient counts and percentages. Study endpoints and variables will be evaluated using descriptive statistics, and the key figures of the distributions will be presented in tables. Univariate analyses will allow for a first overview of potentially influential factors.
Multiple linear regression models will be performed in order to evaluate predictors of functional recovery at 3 months and 6 months after surgery.
Exploratory subgroup analyses will be performed. Missing values will be replaced and estimated using multiple imputations. Furthermore, sensitivity analysis will be executed using complete-case analysis.
A sample size of 265 patients who completed pre and postoperative EQ VAS questionnaires will have a 90% power to detect an effect size of 0,2 between pre and post surgery ,using a paired t-test with a 0,05 two sided significance level.
Given a potential loss to follow-up (about 10%), uncompleted questionnaires (about 10%) and postoperative mortality (about 15%), the sample size will be increased to 350-400 patients (see ref 18 and 19).
研究类型
注册 (实际的)
联系人和位置
学习地点
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Petah Tikva、以色列、4592500
- Rabin Medical Center
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Thessaloníki、希腊、54248
- Medical School, Aristotle University of Thessaloniki
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Milano、意大利、20162
- Ospedale Niguarda
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Piacenza、意大利、29121
- Ospedale di Piacenza
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Vercelli、意大利、13100
- Clinica S. Rita
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Forli-Cesena
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Forlì、Forli-Cesena、意大利、47121
- Ospedale di Forlì
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Lazio
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Roma、Lazio、意大利、00100
- Ospedale S. Andrea
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Liguria
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Genova、Liguria、意大利、16121
- IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
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Genova、Liguria、意大利、16121
- IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
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Milano
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Rozzano、Milano、意大利、20089
- Humanitas
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Monza E Brianza
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Desio、Monza E Brianza、意大利、20039
- Ospedale di Desio
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Perugia
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Spoleto、Perugia、意大利、06049
- Ospedale S. Matteo degli Infermi
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Puglia
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Bari、Puglia、意大利、70121
- IstitutoTumori Giovanni Paolo II
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Ravenna
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Faenza、Ravenna、意大利、48018
- General Surgery Unit
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Rimini
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Riccione、Rimini、意大利、47838
- Ospedale di Riccione
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Oslo、挪威
- Institute of clinical medicine
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Kraków、波兰
- Jagiellonian University Medical College
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Florida
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Weston、Florida、美国、33331
- Cleveland Clinic Florida
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvenia Medical Center
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Rhode Island
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Providence、Rhode Island、美国、02908
- Roger William Medical Centre
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Liverpool、英国
- Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
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Manchester、英国
- Manchester Royal Infirmary, University of Manchester
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Groningen、荷兰
- Groeningen University Hospital
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Lisbon、葡萄牙
- General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
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Santiago do Cacém、葡萄牙、7500
- Unidade Local de Saúde do Litoral Alentejano (ULSLA)
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Alicante、西班牙、03001
- Universidad Miguel Hernández. Elche. Alicante
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Valencia、西班牙、46700
- Hospital Universitario y Politecnico La Fe
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients undergoing emergent/urgent surgical procedures
- Planned hospital stay less than 48 hours
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Group 1
Elderly patiences with solid malignancy
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Quality of Life and Functional recovery questionnaires
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Quality of Life (QoL)
大体时间:6 months
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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
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Functional recovery (FR)
大体时间:6 months
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To evaluate FR in terms of nutritional status, restoration of daily activities and cognitive status
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6 months
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Morbidity
大体时间:6 months
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To evaluate 3 and 6 months postoperative morbidity
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6 months
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Mortality
大体时间:6 months
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To evaluate 3 and 6 months postoperative mortality
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6 months
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Prognostic factors
大体时间:6 months
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To obtain prognostic factors for postoperative functional recovery which will assist in the treatment planning /intervention of future elderly patients who are offered surgery for cancer
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6 months
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合作者和调查者
赞助
合作者
调查人员
- 首席研究员:Giampaolo Giampaolo, MD、Ausl Romagna
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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