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NCT06017141

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

UNKNOWN
PHASE2Ages 18+InterventionalTreatment
University of Kansas Medical Center
~80 participants
Updated 2023-08-30 on ClinicalTrials.gov
What's tested:Biospecimen CollectionElectronic Health Record ReviewFentanyl CitratePropofolQuestionnaire AdministrationSevoflurane

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Neutrophil extracellular traps (NET) formation
Measured over Post-operative day (POD) 1 to POD 6 months

Conditions

Colon Adenocarcinoma

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Colon Adenocarcinoma

NCT06017141

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Kansas Cancer Center

    Kansas City, Kansasstudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Luke V Selby · PRINCIPAL_INVESTIGATOR · University of Kansas

Who to contact

Luke V. Selby
[email protected]
913-588-7750
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Neutrophil extracellular traps (NET) formationPost-operative day (POD) 1 to POD 6 months

    The Neutrophil extracellular traps (NET) formation will be assessed by DNA complexes in myeloperoxidase (MPO). MPO are enzymes that come from white blood cells. The level of these enzymes will be compared by study group using statistical models. The time you are under anesthesia, the amount of anesthesia you are given, the type of surgery you have are all variables that will be considered when evaluating the two types of anesthesia.