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
1 other identifier
observational
1,004
10 countries
28
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Typical duration for all trials
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 27, 2017
CompletedFirst Submitted
Initial submission to the registry
September 20, 2017
CompletedFirst Posted
Study publicly available on registry
October 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedMay 9, 2019
May 1, 2019
2.9 years
September 20, 2017
May 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Quality of Life (QoL)
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
6 months
Secondary Outcomes (4)
Functional recovery (FR)
6 months
Morbidity
6 months
Mortality
6 months
Prognostic factors
6 months
Study Arms (1)
Group 1
Elderly patiences with solid malignancy
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Patients undergoing emergent/urgent surgical procedures
- Planned hospital stay less than 48 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Pennsylvenia Medical Center
Philadelphia, Pennsylvania, 19104, United States
Roger William Medical Centre
Providence, Rhode Island, 02908, United States
Medical School, Aristotle University of Thessaloniki
Thessaloniki, 54248, Greece
Rabin Medical Center
Petah Tikva, 4592500, Israel
IstitutoTumori Giovanni Paolo II
Bari, Apulia, 70121, Italy
Ospedale di Forlì
Forlì, Forli-Cesena, 47121, Italy
Ospedale S. Andrea
Rome, Lazio, 00100, Italy
IRCCS Ospedale S. Martino Genova, Chirurgia Generale ad indirizzo oncologico
Genoa, Liguria, 16121, Italy
IRCCS Ospedale S. Martino Genova, Clinica Chirurgica 1
Genoa, Liguria, 16121, Italy
Humanitas
Rozzano, Milano, 20089, Italy
Ospedale di Desio
Desio, Monza E Brianza, 20039, Italy
Ospedale S. Matteo degli Infermi
Spoleto, Perugia, 06049, Italy
General Surgery Unit
Faenza, Ravenna, 48018, Italy
Ospedale di Riccione
Riccione, Rimini, 47838, Italy
Ospedale Niguarda
Milan, 20162, Italy
Ospedale di Piacenza
Piacenza, 29121, Italy
Clinica S. Rita
Vercelli, 13100, Italy
Groeningen University Hospital
Groningen, Netherlands
Institute of clinical medicine
Oslo, Norway
Jagiellonian University Medical College
Krakow, Poland
General Surgery dept,Hospital Sao Francisco Xavier (CHLO)
Lisbon, Portugal
Unidade Local de Saúde do Litoral Alentejano (ULSLA)
Santiago do Cacém, 7500, Portugal
Universidad Miguel Hernández. Elche. Alicante
Alicante, 03001, Spain
Hospital Universitario y Politécnico La Fe
Valencia, 46700, Spain
Dept. of Surgical Oncology - St. Helens Hospital of Liverpool
Liverpool, United Kingdom
Manchester Royal Infirmary, University of Manchester
Manchester, United Kingdom
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giampaolo Giampaolo, MD
AUSL Romagna
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Azienda USL della Romagna
Study Record Dates
First Submitted
September 20, 2017
First Posted
October 3, 2017
Study Start
February 27, 2017
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
May 9, 2019
Record last verified: 2019-05