Anesthesia and Postoperative Outcome in Colorectal Cancer Patients

January 14, 2022 updated by: Prof.Dr.Daniela Ionescu, Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

The Influence of Anesthesia on Postoperative Outcome and Complications in Colorectal Cancer Patients

Study aims to compare the influence of TIVA and sevoflurane anesthesia with or without lidocaine on postoperative short and long term outcome in patients with colorectal cancer undergoing surgery.

As short term endpoints postoperative pain and opioid consumption, resumption of bowel function, PONV, LOS will be registered.

Long term outcome parameters include: the incidence of chronic pain, 1 and 5 years cancer recurrences incidence and mortality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Main goals

  1. Comparative evaluation of the incidence of recurrences after TIVA vs sevoflurane anesthesia
  2. Evaluation of the effect of lidocaine infusion associated with TIVA/sevoflurane on the incidence of chronic pain and of cancer recurrences and survival.

Secondary objectives

  1. Evaluation of the influence of lidocaine on postoperative outcome in patients with colorectal cancer
  2. Evaluation of the influence of lidocaine on postoperative inflammatory response
  3. Evaluation of the influence of lidocaine on the incidence and severity of postoperative pain and outcome in patients with colorectal cancer

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Romania
    • Cluj
      • Cluj-Napoca, Cluj, Romania
        • Recruiting
        • Institutul Oncologic Prof Dr Ion Chiricuta
        • Contact:
      • Cluj-napoca, Cluj, Romania, 400162
        • Recruiting
        • Clinica ATI, str Croitorilor nr 19-21
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tiberiu Tat, PhD student
        • Sub-Investigator:
          • Alexandru Alexa, PhD student

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elective surgery

Exclusion Criteria:

  • • persistent chronic pain

    • chronic medication that may interfere with pain: antiepileptics, NSAID, corticoids
    • Contraindications for any of the study medications
    • Significant psychiatric disorders (Axa I) (major depression, bipolar disorders, schizophrenia, etc.)
    • Significant hepatic (ALAT and/or ASAT > 2 normal values) or renal (plasma creatinine > 2 mg/dl) disorders
    • Convulsive disorders requiring medication during the last 2 years
    • Planned regional analgesia/anesthesia (spinal or epidural)
    • Corticoid dependent asthma
    • Autoimmune disorders
    • Anti-arrhythmic medication (verapamil, propafenone, amiodarone) that may interfere with lidocaine's anti-arrhythmic effects
    • Refusal for study participation

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: TIVA + lidocaine

TIVA-L. Patients allocated to receive TIVA (propofol-fentanyl) with lidocaine infusion.

Interventions: TIVA+lidocaine
Drug: TIVA+lidocaine
Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
Other Names:
  • TIVA-L
Placebo Comparator: TIVA+placebo
TIVA-P. Patients allocated to receive TIVA without lidocaine (placebo). Intervention: TIVA+placebo (saline infusion)
Drug: TIVA+placebo
Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
Other Names:
  • TIVA-P
Placebo Comparator: Sevoflurane+placebo

Sevo-P. Patients allocated to receive Sevoflurane anesthesia without lidocaine infusion (placebo).

Intervention: sevoflurane anesthesia +placebo (saline infusion)
Drug: Sevoflurane+placebo
Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
Other Names:
  • Sevo-P
Active Comparator: Sevoflurane+lidocaine

Sevo-L. Patients allocated to receive sevoflurane anesthesia with lidocaine infusion for the first 48 h postoperatively.

Intervention: sevoflurane anesthesia+ lidocaine infusion
Drug: Sevoflurane+lidocaine
Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
Other Names:
  • Sevo-L

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival after TIVA vs sevoflurane anesthesia in patients operated for colorectal cancer
Time Frame: 5 years
Survival at 5 years will be recorded
5 years
Incidence of recurrences:
Time Frame: 5 years
The incidence of recurrences will be registered annually and reported from the first year to 5 years respectively in all 4 groups of patients.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Morphine consumption during the first 24 postoperative hours
Time Frame: 0- 24 h
Total morphine consumption during the first 24h after surgery will be recorded
0- 24 h
Severity of postoperative pain - verbal response pain (VRPS) score 1-10, (1=no pain, 10=worst pain) in recovery room and during the first 48 hrs postoperatively. Target verbal response pain score ≤3
Time Frame: 0- 48 h
The severity of postoperative pain will be recorded along with morphine consumption.Pain intensity will be followed during the first 48 h postoperatively.
0- 48 h
Resumption of bowel function
Time Frame: 0-72 h
Time to first flatus will be registered and compared between groups.
0-72 h
Length of hospital stay
Time Frame: 0-10 days
LOS will be registered and compared between study groups.
0-10 days
Postoperative chronic pain
Time Frame: 1 year

Chronic pain at 6 month and 1 year respectively will be assessed with McGill questionnaire by telephone interview.

Scores range from 0 (no pain) to 78 (severe pain), patients with high scores need to seek medical advice
1 year
Postoperative imflamation
Time Frame: Day 1
Evaluation of the influence of lidocaine on 24-hour postoperative inflammatory response; All patients will have leukocytes count and c protein reactive (PCR) so an analysis can be made.
Day 1
Rate of postoperative complications after intravenous lidocaine infusion versus placebo
Time Frame: 0-30 days
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia
0-30 days
Rate of postoperative complications after TIVA versus inhalation anaesthesia
Time Frame: 0-30 days
Monitoring the incidence of some common perioperative complications: pulmonary embolism, pulmonary edema, acute kidney injury, anastomosis leak, myocardial infarction, stroke, pneumonia
0-30 days

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of local anaesthetics systemic toxicity incidence
Time Frame: 0-48 hours
An investigator will note any signs of local anaesthetics systemic toxicity at the bed site of patient
0-48 hours

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Prof. Dr. I. Chiricuta Institute of Oncology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daniela Ionescu, Prof, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca
  • Principal Investigator: Alexandru Alexa, Assist Prof, Iuliu Hatieganu University of Medicine and Pharmacy, Cluj-Napoca

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 53/14.03.2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Regular meeting for sharing data.

IPD Sharing Time Frame

Data will be shared between cooperation institutions every 3 month and whenever necessary.

IPD Sharing Access Criteria

Access criteria are: active involvement into the study, the need to register data into the common database.

The need to report data into the PhD thesis is also an access criteria.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

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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