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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

Must not have

Diagnosis of rectal adenocarcinoma

Planned multi-visceral resection (examples include: pelvic exenteration, combined liver and colon resection)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative day 0 to post-operative discharge, approximately 2-4 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am medically cleared for surgery to remove part of my colon.

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I, or my legal representative, can understand the study and agree to sign the consent form.

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I can take care of myself and am up and about more than half of my waking hours.

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I am having surgery to remove a part of my colon with cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with rectal cancer.

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I am scheduled for a complex surgery involving multiple organs.

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I have not had surgery for polyps that couldn't be fully removed or had incomplete removals without confirmed cancer.

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I or my close family member have had a severe reaction to certain anesthesia.

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I have been diagnosed with inflammatory bowel disease.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 0 to post-operative discharge, approximately 2-4 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Neutrophil extracellular traps (NET) formation

Secondary study objectives

Changes in gene expression

Circulating tumor deoxyribonucleic acid (ctDNA)

Early post-operative recovery

+10 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

Fentanyl Citrate

2019

Completed Phase 4

~500