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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03575416
Other study ID # INT 100-18
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 3, 2018
Est. completion date November 1, 2018

Study information

Verified date July 2018
Source Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Contact Franco Valenza, MD
Phone +39022390
Email franco.valenza@istitutotumori.mi.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Subjects undergoing cancer related surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori - Milano will be consecutively recruited. Data regarding presence of co-morbidities, frailty, cancer staging, and inflammatory status (CRP protein measurement) will be collected preoperatively. Intra-operative data collection will comprehend type and duration of surgery, kind of anesthesia, complications. In-hospital mortality will be considered as the primary endpoint, while secondary outcome measures will be duration of hospital stay and admission to intensive care.


Description:

A prospective data collection of pre-intra and postoperative variables will be collected in a cohort of subjects undergoing cancer relate surgery at the Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date November 1, 2018
Est. primary completion date September 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Subjects undergoing cancer related surgery at the Fondazione IRCSS Istituto Nazionale dei Tumori, Milano

Exclusion Criteria: Day case surgery

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Italy Fondazione IRCSS Istituto Nazionale dei Tumori Milan MI

Sponsors (1)

Lead Sponsor Collaborator
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary In-hospital mortality 30 days
Secondary Duration of hospital stay 30 days
Secondary Admission to intensive care. 30 days
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