Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2018-07-03
2018-11-01
Brief Summary
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Detailed Description
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BEFORE SURGERY Subjects will be stratified before surgery according to the following three main clusters: 1) Systemic inflammation: baseline levels of C Reactive Protein; 2) Cancer staging: TNM will be taken into account, together with the type of cancer, previous radio or chemo therapy, and planned/performed surgical procedure; 3) Frailty: subjects will be stratified according to their overall status, taking into account elements of frailty. Co-existing diseases such as diabetes, hypertension, cardiac heart failure, acute myocardial infarction, chronic obstructive disease/asthma, kidney or liver disease (past or present) will be considered. Functional status will be assessed by means of ASA, ECOG status and Possum scores. Frailty will be explored using the mFI and G8 score, the WHO scale, and considering age. Absolute BMI and loss of weight will be used to assess malnutrition.
DURING SURGERY Duration and type of surgery, kind of anesthesia and intra-operative complications will be considered.
AFTER SURGERY Hospital mortality, length of stay, and admission to intensive care will be considered as outcome measures. Major complications, such as myocardial infarction, arrhythmia, cardio circulatory arrest, shock, stroke, pulmonary embolism, kidney failure, delirium, pneumonia or SSI will also be considered.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria: Day case surgery
ALL
No
Sponsors
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Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
OTHER
Responsible Party
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Principal Investigators
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Franco Valenza, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Locations
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Fondazione IRCSS Istituto Nazionale dei Tumori
Milan, MI, Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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INT 100-18
Identifier Type: -
Identifier Source: org_study_id
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