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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Florida
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Weston、Florida、アメリカ、33331
- Cleveland Clinic Florida
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Massachusetts
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Boston、Massachusetts、アメリカ、02115
- Brigham and Women's Hospital
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvenia Medical Center
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Rhode Island
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Providence、Rhode Island、アメリカ、02908
- Roger William Medical Centre
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Liverpool、イギリス
- Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
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Manchester、イギリス
- Manchester Royal Infirmary, University of Manchester
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Petah Tikva、イスラエル、4592500
- Rabin Medical Center
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Milano、イタリア、20162
- Ospedale Niguarda
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Piacenza、イタリア、29121
- Ospedale di Piacenza
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Vercelli、イタリア、13100
- Clinica S. Rita
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Forli-Cesena
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Forlì、Forli-Cesena、イタリア、47121
- Ospedale di Forlì
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Lazio
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Roma、Lazio、イタリア、00100
- Ospedale S. Andrea
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Liguria
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Genova、Liguria、イタリア、16121
- IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
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Genova、Liguria、イタリア、16121
- IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
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Milano
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Rozzano、Milano、イタリア、20089
- Humanitas
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Monza E Brianza
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Desio、Monza E Brianza、イタリア、20039
- Ospedale di Desio
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Perugia
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Spoleto、Perugia、イタリア、06049
- Ospedale S. Matteo degli Infermi
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Puglia
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Bari、Puglia、イタリア、70121
- IstitutoTumori Giovanni Paolo II
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Ravenna
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Faenza、Ravenna、イタリア、48018
- General Surgery Unit
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Rimini
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Riccione、Rimini、イタリア、47838
- Ospedale di Riccione
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Groningen、オランダ
- Groeningen University Hospital
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Thessaloníki、ギリシャ、54248
- Medical School, Aristotle University of Thessaloniki
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Alicante、スペイン、03001
- Universidad Miguel Hernández. Elche. Alicante
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Valencia、スペイン、46700
- Hospital Universitario y Politécnico La Fe
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Oslo、ノルウェー
- Institute of Clinical Medicine
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Lisbon、ポルトガル
- General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
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Santiago do Cacém、ポルトガル、7500
- Unidade Local de Saúde do Litoral Alentejano (ULSLA)
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Kraków、ポーランド
- Jagiellonian University Medical College
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of Life (QoL)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Functional recovery (FR)
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Giampaolo Giampaolo, MD、AUSL Romagna
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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Questionnairesの臨床試験
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University Hospital, BordeauxRestless Legs Syndrome Foundation募集
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University Hospital, Strasbourg, Franceまだ募集していません複雑な心的外傷後ストレス障害 (CPTSD) | 心的外傷後ストレス障害 (PTSD) | 境界性パーソナリティ障害 (BPD)