Comparing inhalational and intravenous anesthesia for colon cancer surgery
VIVA: Volatile or IV Anesthesia for Cancer
This study is testing whether using inhaled anesthesia or intravenous anesthesia during colon cancer surgery helps patients recover better and have a stronger immune response.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06017141 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effects of inhalational anesthesia versus total intravenous anesthesia (TIVA) on recovery and immune response in patients undergoing surgery for colon adenocarcinoma. The primary objective is to assess how these anesthesia types influence inflammation and immunosuppression. Secondary objectives include measuring post-operative recovery, complications, and survival outcomes through patient-reported outcomes and electronic medical records. The study aims to provide insights into the optimal anesthesia choice for improving surgical recovery in colon cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with biopsy-proven colon adenocarcinoma scheduled for surgical resection.
Not a fit: Patients with rectal adenocarcinoma or those with psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance recovery and reduce complications for patients undergoing colon cancer surgery.
How similar studies have performed: Other studies have shown varying results with different anesthesia approaches, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Kansas
- University of Kansas Cancer Center — Kansas City, Kansas, United States (Recruiting)
Study contacts
- Principal investigator: Luke V Selby — University of Kansas
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.