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NCT Number: NCT07237438

TIVA Versus Balanced Anesthesia on Muscle Mass in CRC 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.

Recruiting

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

total intravenous anaesthesia

Procedure

evaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass

sevoflurane anaesthesia

Procedure

evaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Hospital length of stay

    Time frame: From enrollment to the patient discharge, up to 52 weeks

  2. Mortality

    Time frame: 28 and 90-day mortality after surgery

Other outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ianis Siriopol

CONTACT

[email protected]

+40 746215 967

Sponsors and collaborators

Lead sponsor

Grigore T. Popa University of Medicine and Pharmacy

Other

Collaborators

  • Regional Institute of Oncology, Iasi, Romania

Registry information

Official study title

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

Acronym: TIVABAL-CRC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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