Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study
VIVA: Volatile or IV Anesthesia for Cancer
University of Kansas Medical Center
80 participants
May 22, 2023
INTERVENTIONAL
Conditions
Summary
This trial evaluates how inhalational anesthesia (drawn in through the lungs) and total intravenous anesthesia (TIVA) (through a needle in a vein in the arm) change the body's ability to recover from surgery or whether they impact the immune system immediately after surgery in patients with colon cancer. It is unknown whether these types of anesthesia change recovery from surgery or change the chances cancer comes back following surgery. This study may help researchers learn how different types of anesthesia affect recovery from colon cancer surgery.
Eligibility
Inclusion Criteria7
- Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
- Males and females age \>= 18 years on day of consent
- Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2
- Patients undergoing resection for biopsy proven colon adenocarcinoma
- Medically fit for colon resection
- Ability to complete required study questionnaires
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria10
- Diagnosis of rectal adenocarcinoma
- Simultaneously enrolled in any therapeutic clinical trial. Subsequent enrollment in an adjuvant therapy clinical trial is not automatically prohibited by this trial. Trial eligibility for subsequent studies will be determined by the VIVA principal investigator (PI) and the PI of the other clinical trial in question
- Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
- Active grade 3 (per the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
- Prisoner status
- Allergies to eggs, egg products, soybeans, or soy products (relative or absolute contraindication to propofol)
- Personal or first degree relative with a history of malignant hyperthermia (absolute contraindication to inhaled volatile anesthetics)
- Diagnosis of inflammatory bowel disease
- Planned multi-visceral resection (examples include: pelvic exenteration, combined liver and colon resection)
- Patients undergoing resection for unresectable polyps, or incomplete polypectomies without biopsy proven adenocarcinoma are excluded
Interventions
Undergo blood and tissue sample collection
Ancillary studies
Given via injection
Given IV
Ancillary studies
Given via inhalation
Undergo SOC surgery
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06017141