TIVA Versus Balanced Anesthesia on Muscle Mass in CRC Surgery

NCT07237438 | Recruiting

• 1 other identifier: 358/11.08.2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

colorectal cancer; sarcopenia; ultrasound; bioimpedance

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  From enrollment to 5 days after surgery

Secondary Outcomes (2)

• Hospital length of stay

  From enrollment to the patient discharge, up to 52 weeks

• Mortality

  28 and 90-day mortality after surgery

Other Outcomes (1)

• Correlation

  From enrollment to 5 days after surgery

Study Arms (2)

total intravenous anaesthesia

ACTIVE COMPARATOR

Procedure: total intravenous anaesthesia

sevoflurane anaesthesia

ACTIVE COMPARATOR

Procedure: sevoflurane anaesthesia

Interventions

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

total intravenous anaesthesia

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

sevoflurane anaesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Grigore T. Popa University of Medicine and Pharmacy: lead
• Regional Institute of Oncology, Iasi, Romania: collaborator

Study Sites (1)

Regional Institute of Oncology, Iaşi, Romania

Iași, Romania

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Sarcopenia

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Ianis Siriopol

CONTACT

+40 746215 967; ianis.siriopol@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: November 19, 2025
• Study Start: September 20, 2025
• Primary Completion: February 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-09

Locations

RO (1)