NCT04259398

Brief Summary

This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
797

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2020May 2028

First Submitted

Initial submission to the registry

February 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 6, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
8.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2028

Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

8.2 years

First QC Date

February 4, 2020

Last Update Submit

November 20, 2023

Conditions

Keywords

anesthesiapropofolcancerinhalational anesthetics

Outcome Measures

Primary Outcomes (1)

  • five year survival

    survival rate regardless of recurrence

    five years survival

Secondary Outcomes (5)

  • five year recurrence free survival

    five years after surgery

  • 1 year recurrence free survival

    1 year after surgery

  • 3 year recurrence free survival

    3 years after surgery

  • 1 year survival

    1 year after surgery

  • 3 year survival

    3 years after surgery

Study Arms (2)

TIVA

EXPERIMENTAL

propofol infusion targeting bispectral index 40-60

Drug: Propofol

inhalation (Sevoflurane)

ACTIVE COMPARATOR

sevoflurane targeting bispectral index 40-60

Drug: Sevoflurane

Interventions

propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia

TIVA

sevoflurane is administered for induction and maintenance of anesthesia

inhalation (Sevoflurane)

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults undergoing surgery to remove colon cancer

You may not qualify if:

  • pregnancy
  • colon cancer with invasion to perineum
  • palliative surgery
  • history of diagnosis or surgery for other cancer
  • emergent surgery
  • ASA PS classification 4 and 5
  • refusion to participate in the study
  • allergy to anesthetics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Seoul Metropolitan Government Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasms

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (full)

Study Record Dates

First Submitted

February 4, 2020

First Posted

February 6, 2020

Study Start

February 18, 2020

Primary Completion (Estimated)

May 3, 2028

Study Completion (Estimated)

May 3, 2028

Last Updated

November 22, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations