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Procedure
Inhalational vs Intravenous Anesthesia for Colorectal Cancer Surgery
Phase 2
Recruiting
Led By Luke V Selby
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Medically fit for colon resection
Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 0 to post-operative discharge, approximately 2-4 days
Awards & highlights
Study Summary
This trial evaluates how different types of anesthesia affect recovery from colon cancer surgery. It may help researchers learn how they impact the immune system after surgery.
Who is the study for?
This trial is for adults (18+) with colon cancer who are medically fit for surgery and can complete study questionnaires. They must be willing to follow the study procedures throughout its duration, have an ECOG status of 0-2, and provide written consent. Excluded are those with allergies to eggs or soy, a history of malignant hyperthermia, rectal adenocarcinoma diagnosis, enrollment in another therapeutic trial, severe psychiatric or social issues affecting compliance, active serious infections within two weeks prior to treatment start date, prisoner status, inflammatory bowel disease diagnosis or planned complex surgeries.Check my eligibility
What is being tested?
The VIVA Study is testing whether inhalational anesthesia (breathed in) versus total intravenous anesthesia (TIVA) affects recovery from colon cancer surgery and impacts the immune system post-surgery. It aims to determine if these types of anesthesia influence surgical recovery outcomes or cancer recurrence rates.See study design
What are the potential side effects?
Potential side effects may include typical risks associated with general anesthesia such as nausea, vomiting, sore throat from breathing tubes during surgery; rare but serious complications like allergic reactions; and specific concerns related to propofol use which could involve egg or soy allergy reactions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am medically cleared for surgery to remove part of my colon.
Select...
I, or my legal representative, can understand the study and agree to sign the consent form.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Select...
I am having surgery to remove a part of my colon with cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day 0 to post-operative discharge, approximately 2-4 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 0 to post-operative discharge, approximately 2-4 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Neutrophil extracellular traps (NET) formation
Secondary outcome measures
Changes in gene expression
Circulating tumor deoxyribonucleic acid (ctDNA)
Early post-operative recovery
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (fentanyl citrate, propofol)Experimental Treatment6 Interventions
Patients receive SOC sedation with fentanyl IV and propofol IV on study during to SOC surgery. Patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
Group II: Arm I (sevoflurane, fentanyl citrate, propofol)Active Control7 Interventions
Patients receive SOC sedation with sevoflurane via inhalation and fentanyl IV on study during to SOC surgery. All patients also undergo blood sample collection throughout the study and collection of tissue sample during surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Surgical Procedure
2020
Completed Phase 2
~160
Biospecimen Collection
2004
Completed Phase 2
~1700
Fentanyl Citrate
2019
Completed Phase 4
~500
Propofol
2017
Completed Phase 4
~1530
Find a Location
Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
463 Previous Clinical Trials
169,190 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,670 Previous Clinical Trials
40,926,356 Total Patients Enrolled
Luke V SelbyPrincipal InvestigatorUniversity of Kansas
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are partaking in this medical experiment?
"Affirmative. According to the information on clinicialtrials.gov, this clinical trial is still searching for patients since its initial posting date of May 22nd 2023 and its last update on August 23rd 2023. The research team needs 80 individuals from 1 location to join the study."
Answered by AI
Are there vacancies in this trial for participants?
"According to the information on clinicaltrials.gov, this research project is still open for participants. This trial was initially announced on May 22nd 2023 and most recently modified on August 23rd of 2023."
Answered by AI
To what extent is Arm II (fentanyl citrate, propofol) potentially hazardous for individuals?
"Our team at Power has assigned Arm II (fentanyl citrate, propofol) a score of 2 in terms of safety. This is due to the fact that we are currently in Phase 2 trials, meaning there have been some preliminary studies confirming its security but none affirming its efficacy."
Answered by AI
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