Colorectal Cancer (CRC)TIVABAL-CRCNCT07237438
TIVA Versus Balanced Anesthesia on Muscle Mass in CRC Surgery
A study testing total intravenous anaesthesia and sevoflurane anaesthesia in people with Colorectal Cancer (CRC) and Sarcopenia, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer (CRC), Sarcopenia
- What is being tested?
- total intravenous anaesthesia and sevoflurane anaesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteRomania
- Study dates
- 27 Sep 2025to 20 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patients diagnosed with colorectal cancer and scheduled for open colorectal surgery at the Regional Institute of Oncology, Iaşi, Romania
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Colorectal Cancer (CRC), Sarcopenia
- Being tested
- total intravenous anaesthesia, sevoflurane anaesthesia
- Keywords
- colorectal cancer, sarcopenia, ultrasound, bioimpedance
- Medical subject headings
- Colorectal Neoplasms, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total intravenous anaesthesiaProcedure or surgery
evaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass
sevoflurane anaesthesiaProcedure or surgery
evaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass
| Study group | Role | What they receive |
|---|---|---|
| total intravenous anaesthesia | Active comparator | Not described Receives: Procedure: total intravenous anaesthesia |
| sevoflurane anaesthesia | Active comparator | Not described Receives: Procedure: sevoflurane anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic assessment of muscle mass
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.
Measured: From enrollment to 5 days after surgery
Muscle function assessment
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.
Measured: From enrollment to 5 days after surgery
Bioimpedance assessment of lean and fat tissue mass
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.
Measured: From enrollment to 5 days after surgery
Secondary outcomes (2)
Hospital length of stay
Measured: From enrollment to the patient discharge, up to 52 weeks
Mortality
Measured: 28 and 90-day mortality after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start27 Sep 2025
- Primary completion20 Feb 2026
- Study completion20 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Cancer (CRC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grigore T. Popa University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Collaborators
- Regional Institute of Oncology, Iasi, Romania
- Responsible party
- Principal investigator, Ianis Siriopol, Grigore T. Popa University of Medicine and Pharmacy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237438
- Sponsor's protocol ID
- 358/11.08.2025
- Acronym
- TIVABAL-CRC
- Status last verified
- Sep 2025
- First submitted
- 23 Sep 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Intravenous Anesthesia Versus Balanced Anesthesia on Loss of Muscle Mass After Colorectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT07237438
- Acronym / sponsor ID
- TIVABAL-CRC / 358/11.08.2025
- Conditions
- Colorectal Cancer (CRC), Sarcopenia
- Keywords
- colorectal cancer, sarcopenia, ultrasound, bioimpedance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Grigore T. Popa University of Medicine and PharmacyUniversity, hospital or other
- Collaborators
- Regional Institute of Oncology, Iasi, Romania
- Study start
- 27 Sep 2025 (actual)
- Primary completion
- 20 Feb 2026 (actual)
- Study completion
- 20 Jun 2026 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| total intravenous anaesthesia | Active comparator | Procedure: total intravenous anaesthesia |
| sevoflurane anaesthesia | Active comparator | Procedure: sevoflurane anaesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients diagnosed with colorectal cancer and scheduled for open colorectal surgery at the Regional Institute of Oncology, Iaşi, Romania
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| total intravenous anaesthesiaevaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass | Procedure or surgery | total intravenous anaesthesia |
| sevoflurane anaesthesiaevaluate the impact of the type of anaesthesia (total intravenous anaesthesia (TIVA)/sevoflurane anaesthesia) for colorectal surgery on the muscle function and mass | Procedure or surgery | sevoflurane anaesthesia |
Primary outcome
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.
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.
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.
2 secondary outcomes
Hospital length of stay
Time frame: From enrollment to the patient discharge, up to 52 weeks
Mortality
Time frame: 28 and 90-day mortality after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing total intravenous anaesthesia and sevoflurane anaesthesia in people with Colorectal Cancer (CRC) and Sarcopenia, run by Grigore T. Popa University of Medicine and Pharmacy at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic assessment of muscle mass (time frame: From enrollment to 5 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.