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NCT Number: NCT06889714

Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients

After obtaining ethical approval, 42 patients with American Society of Anesthesiologists (ASA) scores I-III who were scheduled for surgery under general anesthesia were included in our prospective study. Patients were monitored in the preoperative preparation room in the operating room and frailty was assessed using the FRAIL scale and sarcopenia was assessed using the STAR ratio. The thickness of the rectus femoris and vastus intermedius muscles of the patients was measured and recorded by ultrasonography. Thigh lengths were measured and recorded. Rectus Femoris/Thigh Length (RF/B), Vastus Intermedius/Thigh Length (VI/B), and Total Muscle Thickness/Thigh Length (T/B) were calculated and recorded. Patients were followed up according to the Modified Aldrete Score after surgery in the anesthesia recovery unit, and the time to reach 9-10 points was recorded, and the time to leave the recovery unit was recorded. Postoperatively, complications were followed up according to the Clavien-Dindo Classification, and discharge times from the hospital were recorded.

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Key information

Conditions

Frailty Atrophy Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Sarcopenia Signs and Symptoms

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Eskisehir Osmangazi

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

About this study

Frailty is a clinically identifiable state of heightened vulnerability resulting from age-related declines in physiological systems and functions, leading to impaired resilience to stressors. Frailty is highly prevalent among the elderly and is associated with an increased risk of falls, disability, hospitalization, and mortality. Magnetic resonance imaging (MRI) and computed tomography (CT) are considered the gold standard for sarcopenia diagnosisCT is also limited due to radiation exposure and similar logistical constraints. In contrast, ultrasonography (USG) is portable, cost-effective, and can be performed at the bedside without radiation exposure.

Using high-frequency ultrasound probes, peripheral muscle tissues and their dimensions can be rapidly assessed.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • patients over 60 years of age who are undergoing colorectal malignancy surgery under general anesthesia
  • patients willing to participate in the study
  • Patients with ASA score I-III

Exclusion criteria

  • Patients with Parkinson's disease,
  • Alzheimer's disease,
  • history of cerebrovascular events,
  • neuromuscular disease,
  • cognitive dysfunction,
  • severe liver disease,
  • severe heart disease,
  • impaired cooperation due to kidney disease,
  • emergency and trauma patients,
  • patients with bilateral lower extremity amputations

Treatment and study plan

Ultrasonography

Device

Right thigh length (between the right femur greater trochanter and patella) was measured and recorded while the patients were lying supine. A linear transducer (Philips Affiniti 50, Philips Medical Systems, Seattle, WA, United States) was used for ultrasonographic measurements. The rectus femoris (RF) and vastus intermedius (VI) were visualized with the feather-touch technique after a generous amount of ultrasound gel was sprayed in the center of the right thigh, and the thickness of the muscles was determined and recorded using ultrasonography software. After these measurements, the rectus femoris-to-thigh length ratio (RF/B), vastus intermedius-to-thigh length ratio (VI/B), and total muscle thickness-to-thigh length ratio (T/B) were calculated and recorded.

Primary outcomes

  1. age

    Time frame: 1 year

    years old

  2. sex

    Time frame: 1 year

    female, male

  3. height

    Time frame: 1 year

    meter

  4. body weight

    Time frame: 1. year

    kg

  5. educational status

    Time frame: 1 year

    primary school graduate, middle school graduate, high school graduate, university graduate

  6. marital status

    Time frame: 1 year

    married, single, widowed

  7. ASA score

    Time frame: 1 year

    American Society of Anesthesiologists' Classification (ASA 1,2,3,4,5)

  8. rectus femoris muscle thickness

    Time frame: 1 year

    cm

  9. vastus intermedius(VI) thickness

    Time frame: 1 year

    cm

  10. rectus femoris-to-thigh length ratio

    Time frame: 1 year

    ratio

  11. vastus intermedius-thigh length ratio

    Time frame: 1 year

    ratio

  12. total muscle thickness to thigh length ratio

    Time frame: 1 year

    ratio

  13. frailty score

    Time frame: 1 year

    0-NORMAL, 1-2 PRE-FRAİL, 3-5 FRAİL

  14. recovery time from anesthesia

    Time frame: 1 year

    minutes

  15. hospital discharge time

    Time frame: 1 year

    days

  16. Modified Clavien-Dindo Classification

    Time frame: 1 year

    1, 2, 3A, 3B, 4A, 4B, 5

Sponsors and collaborators

Lead sponsor

Eskisehir Osmangazi University

Other

Registry information

Official study title

Investigation of the Effects of Frailty and Sarcopenia on Postoperative Recovery and Complications in Geriatric Patients Undergoing Colorectal Cancer Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 21, 2025
Registry last updated
Mar 27, 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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