Cancer, Breast Clinical Trial
— VAPOR-COfficial title:
Volatile Anaesthesia and Perioperative Outcomes Related to Cancer (VAPOR-C): A Feasibility Study
Verified date | June 2022 |
Source | Peter MacCallum Cancer Centre, Australia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A multicentre, prospective randomized, active-controlled feasibility trial of volatile-based anaesthesia vs. propofol-based total intravenous anaesthesia to investigate the impact of anaesthesia on long-term (i.e. 5-years) patient cancer outcomes in patients undergoing elective major cancer surgery.
Status | Completed |
Enrollment | 169 |
Est. completion date | June 30, 2020 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | Inclusion Criteria: - Male or female - Age 18-80 years - Elective surgery - Major cancer surgery expecting to last two or more hours, for: - Breast (mastectomy or segmentectomy plus sentinel node dissection) - Colorectal - Lung - Prostate - Melanoma (excision of melanoma plus lymph node dissection AND/OR skin flap construction - Other major cancer surgeries (e.g. oesophagectomy, head and neck cancer, etc.) Exclusion Criteria - Palliative surgery for end-stage disease with no curative intent - Emergency surgery - Extensive comorbid disease, i.e. American Society of Anesthesiologists (ASA) Score > 4 - Age <18 or >80 years old - Refusal or inability to provide valid informed consent - Risk of severe postoperative nausea and vomiting (PONV risk score >3) - Previous allergy or contraindication to either anaesthetic medication - Indication for gas induction of anaesthesia - Currently enrolled in another clinical trial unless agreed by the coordinating principal investigator and site principal investigator that co-enrolment can occur. |
Country | Name | City | State |
---|---|---|---|
Australia | Peter MacCallum Cancer Centre | Melbourne |
Lead Sponsor | Collaborator |
---|---|
Peter MacCallum Cancer Centre, Australia | M.D. Anderson Cancer Center, Melbourne Health, The Alfred |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To measure the ability to recruit eligible patients into the study. | The study protocol will be assessed as feasible if a recruitment rate of at least 75% is achieved. | 18 months | |
Primary | To measure the ability to successfully deliver each of the two anaesthetic techniques (volatile-based general anaesthesia and propofol-based anaesthesia) according to the research protocol. | The study protocol will be assessed as feasible if a successful delivery rate of at least 90% is achieved. | 18 months | |
Secondary | To identify that all sites can capture data within the electronic case report form (eCRF) and utilize the electronic data capturing system (REDCap). | All missing data to be recorded including reason for missing data, where available. Quantitative and qualitative analysis of reasons for missing data will be analysed by : Number of fields with missing data (percentage) and reason for missing data ( qualitative descriptor). Fields with >1 missing data point will be analysed for reasons for failure. | 18 months | |
Secondary | To test the efficiency of the centralized patient enrolment and computer randomization system. | Number of events of failed randomisation will be recorded on eCRF (under 'treatment of subjects"). Quantitative analysis of failed randomisation (reported as %) as well as descriptive reason for failure will be recorded and analysed. This will allow shortcomings in the use of the computer-generated centralised randomisation program to be identified and ratified. | 18 months |
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