TIVA Versus Balanced Anesthesia on Muscle Mass in CRC Surgery (TIVABAL-CRC)

November 16, 2025 updated by: Ianis Siriopol, Grigore T. Popa University of Medicine and Pharmacy

Total Intravenous Anesthesia Versus Balanced Anesthesia on Loss of Muscle Mass After Colorectal Cancer Surgery

This study is aimed at clarifying changes in body composition during the perioperative period and identifying risk factors for skeletal muscle mass loss in patients with colorectal cancer. The investigators will asess the impact of the type of anaesthesia (total intravenous anaesthesia/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass, which will be evaluated using ultrasound, dynamometry and bioimpedance.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

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

  • Romania
      • Iași, Romania
        • Recruiting
        • Regional Institute of Oncology, Iaşi, Romania
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

• adult patients diagnosed with colorectal cancer and scheduled for open colorectal surgery at the Regional Institute of Oncology, Iaşi, Romania

Exclusion Criteria:

  • lack the capacity to consent
  • extremity amputation
  • paraplegia
  • diseases affecting the muscles (such as stroke, lower-limb immobilization from a plaster, neurodegenerative diseases, peripheral neuropathy or muscle dystrophy)
  • terminal cancer

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: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: total intravenous anaesthesia
Procedure: total intravenous anaesthesia
evaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass
Active Comparator: sevoflurane anaesthesia
Procedure: sevoflurane anaesthesia
evaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ultrasonographic assessment of muscle mass
Time Frame: From enrollment to 5 days after surgery
Ultrasonographic muscle assessment is standardised in the assessment of muscle according to the SARCUS (Sarcopenia through UltraSound) working group recommendations. Rectus femoris muscle will be evaluated at 50% distance between the anterior superior iliac spine and the superior pole of the patella, in a lying position with knees in 10°, for muscle thickness and muscle cross-sectional area (CSA). Three measurements will be taken for each data point, and the average value will be used for further analysis. The biceps brachii muscle will be evaluated at 50% distance acromioclavicular joint and the elbow crease, in a supine position. Muscle thickness can be easily defined as the maximal vertical distance between the superficial and deep fasciae.
From enrollment to 5 days after surgery
Muscle function assessment
Time Frame: From enrollment to 5 days after surgery
Measuring grip strength is simple and inexpensive. Grip strength will be determined bilaterally. Each measurement will be performed three times on the left and right extremities with 20 seconds intervals between the measurements. The maximum measured value in kilograms will be used for analysis.
From enrollment to 5 days after surgery
Bioimpedance assessment of lean and fat tissue mass
Time Frame: From enrollment to 5 days after surgery
The bioimpedance measurements will be performed by a trained operator according to the manufacturer's recommendations. The Body Composition Monitor provides a quantitative measure of lean tissue and fat tissue mass. In contrast to earlier bioimpedance methodologies, the bioimpedance spectroscopy expresses body composition as a three-compartment model, providing overhydration, lean tissue index (LTI), and fat tissue index (FTI), whereby LTI and FTI are the respective tissue masses normalized to height squared.
From enrollment to 5 days after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Hospital length of stay
Time Frame: From enrollment to the patient discharge, up to 52 weeks
From enrollment to the patient discharge, up to 52 weeks
Mortality
Time Frame: 28 and 90-day mortality after surgery
28 and 90-day mortality after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation
Time Frame: From enrollment to 5 days after surgery
Correlation between muscle strength and muscle mass using dynamometry and echography and bioimpedance at different time points
From enrollment to 5 days after surgery

Collaborators and Investigators

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

Sponsor

Grigore T. Popa University of Medicine and Pharmacy

Collaborators

Regional Institute of Oncology, Iasi, Romania

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)

September 20, 2025

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 23, 2025

First Submitted That Met QC Criteria

November 16, 2025

First Posted (Actual)

November 19, 2025

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 16, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 358/11.08.2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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