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NCT04259398 Clinical Trial

Anesthesia and Cancer Study: Colon Cancer

Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04259398
Other study ID # Ane-Can colon (1912-133-109)
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date February 18, 2020
Est. completion date May 3, 2028

Study information
Verified date November 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 797
Est. completion date May 3, 2028
Est. primary completion date May 3, 2028
Accepts healthy volunteers No
Gender All
Age group 19 Years to 80 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Propofol
propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
• Sevoflurane
sevoflurane is administered for induction and maintenance of anesthesia

Locations
Country Name City State
Korea, Republic of Seoul Metropolitan Government Seoul National University Boramae Medical Center Seoul
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (6)
Lead Sponsor Collaborator
Seoul National University Hospital Bundang Seoul National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Korean Society of Anesthesiologists, Seoul National University Boramae Hospital, Seoul St. Mary's Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary five year survival survival rate regardless of recurrence five years survival
Secondary five year recurrence free survival survival rate without recurrence five years after surgery
Secondary 1 year recurrence free survival survival rate without recurrence 1 year after surgery
Secondary 3 year recurrence free survival survival rate without recurrence 3 years after surgery
Secondary 1 year survival survival regardless of recurrence 1 year after surgery
Secondary 3 year survival survival regardless of recurrence 3 years after surgery
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