- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание NCT03299270
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.
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
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).
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Thessaloníki, Греция, 54248
- Medical School, Aristotle University of Thessaloniki
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Petah Tikva, Израиль, 4592500
- Rabin Medical Center
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Alicante, Испания, 03001
- Universidad Miguel Hernández. Elche. Alicante
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Valencia, Испания, 46700
- Hospital Universitario y Politecnico La Fe
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Milano, Италия, 20162
- Ospedale Niguarda
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Piacenza, Италия, 29121
- Ospedale di Piacenza
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Vercelli, Италия, 13100
- Clinica S. Rita
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Forli-Cesena
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Forlì, Forli-Cesena, Италия, 47121
- Ospedale di Forlì
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Lazio
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Roma, Lazio, Италия, 00100
- Ospedale S. Andrea
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Liguria
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Genova, Liguria, Италия, 16121
- IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
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Genova, Liguria, Италия, 16121
- IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
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Milano
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Rozzano, Milano, Италия, 20089
- Humanitas
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Monza E Brianza
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Desio, Monza E Brianza, Италия, 20039
- Ospedale di Desio
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Perugia
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Spoleto, Perugia, Италия, 06049
- Ospedale S. Matteo degli Infermi
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Puglia
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Bari, Puglia, Италия, 70121
- IstitutoTumori Giovanni Paolo II
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Ravenna
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Faenza, Ravenna, Италия, 48018
- General Surgery Unit
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Rimini
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Riccione, Rimini, Италия, 47838
- Ospedale di Riccione
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Groningen, Нидерланды
- Groeningen University Hospital
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Oslo, Норвегия
- Institute of clinical medicine
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Kraków, Польша
- Jagiellonian University Medical College
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Lisbon, Португалия
- General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
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Santiago do Cacém, Португалия, 7500
- Unidade Local de Saúde do Litoral Alentejano (ULSLA)
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Liverpool, Соединенное Королевство
- Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
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Manchester, Соединенное Королевство
- Manchester Royal Infirmary, University of Manchester
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Florida
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Weston, Florida, Соединенные Штаты, 33331
- Cleveland Clinic Florida
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Massachusetts
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Boston, Massachusetts, Соединенные Штаты, 02115
- Brigham and Women's Hospital
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Pennsylvania
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Philadelphia, Pennsylvania, Соединенные Штаты, 19104
- University of Pennsylvenia Medical Center
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Rhode Island
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Providence, Rhode Island, Соединенные Штаты, 02908
- Roger William Medical Centre
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
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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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Quality of Life (QoL)
Временное ограничение: 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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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
---|---|---|
Functional recovery (FR)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Giampaolo Giampaolo, MD, Ausl Romagna
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Ожидаемый)
Завершение исследования (Ожидаемый)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- GOSAFE
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .
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