Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study

Launched by UNIVERSITY OF KANSAS MEDICAL CENTER · Aug 23, 2023

Keywords

ClinConnect Summary

The VIVA Study is a clinical trial designed to understand how two different types of anesthesia—one that you inhale and another delivered through a vein—affect patients with colon cancer during and after surgery. Researchers want to find out if these anesthesia methods help patients recover better or if they influence how the immune system works right after surgery. This information could be important for improving recovery and possibly reducing the chances of cancer returning after surgery.

To be eligible for this study, participants need to be at least 18 years old and must be undergoing surgery to remove colon cancer that has been confirmed through a biopsy. They should be in good overall health and able to complete some questionnaires about their experience. Participants can expect to receive either inhalational or intravenous anesthesia during their surgery and will be monitored closely to see how they recover. It's important to note that those with certain health conditions, like rectal cancer or specific allergies, would not be able to participate in this trial.

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Eligibility criteria

• Inclusion Criteria:
• • 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 Criteria:
• • 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