Anesthesia and Cancer Study: Colon Cancer

November 20, 2023 updated by: Jin-Tae Kim, Seoul National University Hospital

The Influence of Type of Anesthesia on Mortality and Cancer Recurrence After Colon Cancer Surgery: Multi-center Prospective Randomized Controlled Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.

Study Type

Interventional

Enrollment (Actual)

797

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 07061
        • Seoul Metropolitan Government Seoul National University Boramae Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adults undergoing surgery to remove colon cancer

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TIVA
propofol infusion targeting bispectral index 40-60
Drug: Propofol
propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
Active Comparator: inhalation (Sevoflurane)
sevoflurane targeting bispectral index 40-60
Drug: Sevoflurane
sevoflurane is administered for induction and maintenance of anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five year survival
Time Frame: five years survival
survival rate regardless of recurrence
five years survival

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
five year recurrence free survival
Time Frame: five years after surgery
survival rate without recurrence
five years after surgery
1 year recurrence free survival
Time Frame: 1 year after surgery
survival rate without recurrence
1 year after surgery
3 year recurrence free survival
Time Frame: 3 years after surgery
survival rate without recurrence
3 years after surgery
1 year survival
Time Frame: 1 year after surgery
survival regardless of recurrence
1 year after surgery
3 year survival
Time Frame: 3 years after surgery
survival regardless of recurrence
3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Seoul St. Mary's Hospital
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul National University Boramae Hospital
Korean Society of Anesthesiologists
Bundang Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2020

Primary Completion (Estimated)

May 3, 2028

Study Completion (Estimated)

May 3, 2028

Study Registration Dates

First Submitted

February 4, 2020

First Submitted That Met QC Criteria

February 4, 2020

First Posted (Actual)

February 6, 2020

Study Record Updates

Last Update Posted (Actual)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ane-Can colon (1912-133-109)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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