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SarcopeniaNCT06698289

Preoperative Sarcopenia and Surgical Outcomes in Colorectal Cancer Patients

An observational study of Sarcopenia and Colon Cancer, run by Mersin University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Colorectal cancer is the third most common malignant neoplasm worldwide and the fourth leading cause of cancer-related deaths. Muscle mass loss in oncology patients is most often the result of cancer-related malnutrition. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sarcopenia, Colon Cancer, Rectal Cancer
How many people
70 participants
Where
1 siteTurkey (Türkiye)
Study dates
24 Nov 2024to 1 Jan 2026
How long will I take part?
1 Month
Phase
Observational
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

Study population: This prospective observational study will be conducted at the Department of General Surgery, Mersin University Hospital, between November 15, 2024, and November 15, 2025. The study population consists of adult patients (≥18 years) diagnosed with colorectal cancer who are scheduled for surgical intervention. Patients will be categorized into sarcopenia and non-sarcopenia groups based on EWGSOP criteria, incorporating muscle strength, muscle mass, and physical performance measurements.

Who may be able to join

  • Having a diagnosis of colon cancer
  • Having undergone surgery at Mersin University General Surgery Department as of 15.11.2024
  • Patients aged 18 years and above
  • Patients whose descriptive and clinical characteristics are recorded in their medical files
  • Those who have signed the Informed Volunteer Consent Form/Written Consent Form

Who cannot join

  • Patients under 18 years of age
  • Patients whose descriptive and clinical characteristics are not recorded in the file records
  • Those who did not sign the Informed Volunteer Form/Written Consent Form

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Mersin University

    Mersin

Other trials in Turkey (Türkiye)

About this study

Official title: Prevalence of Preoperative Sarcopenia and Its Impact on Surgical Outcomes in Patients With Colorectal Cancer: A Prospective Study

Colorectal cancer is the third most common malignant neoplasm worldwide and the fourth leading cause of cancer-related deaths. Muscle mass loss in oncology patients is most often the result of cancer-related malnutrition.

Sarcopenia is a progressive and generalized skeletal muscle disorder associated with increased likelihood of adverse outcomes such as physical disability, poor quality of life, and death. It is characterized by low muscle strength, low muscle quantity and quality, and low physical performance. Sarcopenia is highly prevalent in older adults and those with chronic diseases, including cancer. In the context of colorectal cancer, preoperative sarcopenia has been linked to increased postoperative complications, longer hospital stays, and reduced survival.

The aim of this prospective observational study is to evaluate the prevalence of preoperative sarcopenia and postoperative outcomes in patients with colorectal cancer, using validated methods to assess muscle strength, muscle mass, and physical performance.

Read the detailed description

Sarcopenia is directly responsible for functional impairment in the body, increased risk of falls, loss of autonomy, decreased respiratory capacity, and reduced immunity. The diagnostic criteria for sarcopenia include three main components: reduced muscle strength, low muscle quantity, and poor physical performance. Based on these criteria, sarcopenia is categorized into three stages: probable sarcopenia, sarcopenia, and severe sarcopenia.

The relationships between sarcopenia and poor prognosis, such as high postoperative mortality, chemotherapy toxicity, reduced survival, increased infection rates, and prolonged hospital stays, have been emphasized. Surgical resection is an important aspect of colorectal cancer management, and the assessment of sarcopenia as a predictor of perioperative or postoperative morbidity risk can provide valuable prognostic information for surgeons and patients. Therefore, patients diagnosed with colorectal cancer should be screened for sarcopenia from the beginning of their treatment, informed about the potential adverse effects of sarcopenia, and the importance of sarcopenia prevention and treatment strategies should be emphasized.

The prevalence and impact of sarcopenia in patients with colorectal cancer are not well known, as most studies have classified sarcopenia solely based on the presence of low muscle mass on CT scans, which may overestimate the prevalence. The aim of this prospective observational study is to evaluate the prevalence of preoperative sarcopenia and its impact on postoperative outcomes in patients with colorectal cancer, by combining 5 different test methods defined by the European Working Group on Sarcopenia in Older People (EWGSOP) to assess muscle strength, muscle mass, and physical performance. These test are:

  • SARC-F Questionnaire: The SARC-F is a 6-item questionnaire used as a screening tool for sarcopenia. It evaluates 5 components: Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls. Each component is scored from 0 to 2, with a total score ranging from 0 to 10. A score of 4 or higher is considered indicative of sarcopenia.
  • Handgrip Strength Test: Handgrip strength is a proxy measure for overall muscle strength. It is measured using a hand-held dynamometer, with the patient sitting or standing and the arm positioned at a 90-degree angle. Patients perform the test twice, and the higher of the two measurements is recorded. Handgrip strength thresholds for sarcopenia diagnosis: Men: <27 kg, Women: <16 kg
  • 4-Meter Gait Speed Test: This test measures the time it takes a patient to walk 4 meters at their usual pace. Patients start from a standing position and walk at their normal comfortable speed. The time taken to complete the 4-meter distance is recorded. Gait speed threshold for sarcopenia diagnosis: <0.8 m/s
  • 5-Times Sit-to-Stand Test: This test evaluates lower extremity muscle strength and function. Patients start from a seated position in a standard chair, then fully stand up and sit back down 5 times as quickly as possible. The time taken to complete the 5 repetitions is recorded. Threshold for sarcopenia diagnosis: 15 seconds
  • Muscle Measurement on Preoperative CT Scans: CT scans performed for diagnostic or staging purposes are used to assess muscle mass. The cross-sectional area of skeletal muscle is measured at the third lumbar vertebra (L3) level. This L3 skeletal muscle area is normalized to the patient's height squared to calculate the Skeletal Muscle Index (SMI). Thresholds for sarcopenia based on SMI: Men: <43 cm²/m² , Women: <41 cm²/m²

By assessing these different parameters - self-reported function, muscle strength, gait speed, and muscle mass - the study can comprehensively evaluate the presence and severity of sarcopenia in the colorectal cancer patients. The combination of these validated tools provides a robust diagnosis of sarcopenia according to the EWGSOP criteria.

A power analysis was performed using the G*Power (v3.1.7) program to determine the sample size. The power of the study is expressed as 1-β (where β is the probability of a type II error). Based on the study by Ying Zhang et al. titled "Sarcopenia and Its Influencing Factors in Patients With Colorectal Cancer", the difference in grip strength measurements between the sarcopenia and non-sarcopenia groups was used for the calculation. The resulting effect size was calculated as d=0.901, and it was determined that a total of 64 participants, with at least 34 in each group, would be required to achieve 95% power at an α level of 0.05.

This study will include at least 64 patients who meet the inclusion and exclusion criteria. Patients with colorectal cancer who are admitted to the General Surgery Department of Mersin University Hospital and have an indication for surgical intervention will undergo the appropriate surgical procedure. The method to be applied is decided by discussing with the patient, based on the patient and the size of the disease.

The data for this study will be collected between November 2024, and November 2025. During this period, the data of patients who were operated on for colorectal cancer at the General Surgery Department in Mersin University Hospital will be collected. The patients' demographic characteristics, history of semptoms, height, weight, hand grip strength test, 4-meter walking test, 5-time sit-to-stand test, and preoperative computed tomography findings will be recorded at the first admission.

After the surgery, the surgical findings, examination findings, wound complications, and the time to return to daily life will be examined. This data will be obtained through the retrospective review of medical records and confirmed by face-to-face interviews with patients who have attended the outpatient clinic, and then recorded in the data collection form.

Data collection will continue until at least 32 patients each are reached in the sarcopenia and non-sarcopenia groups. Once the target sample size is reached, new data collection from patients will be terminated, and statistical analyses will be performed to compare the prevalence between the groups.

Medical subject headings
Sarcopenia, Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06698289
Study groupRoleWhat they receive
SarcopeniaPatients who meet the diagnostic criteria for sarcopenia will be included in this group. The diagnosis of sarcopenia will be made using the criteria defined by the European Working Group on Sarcopenia in Older People (EWGSOP). This requires the presence of both low muscle strength (e.g. low handgrip strength) and low muscle quantity/quality (e.g. low skeletal muscle index on CT scan). Patients will further classified into stages of "probable sarcopenia", "sarcopenia", and "severe sarcopenia" based on the severity.
Non-sarcopeniaPatients who do not meet the diagnostic criteria for sarcopenia will be included in this group. They will have normal or above-normal muscle strength and muscle quantity/quality measurements. This group will serve as the comparison cohort to evaluate the impact of sarcopenia on surgical outcomes.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Complications

    Postoperative complications will be systematically evaluated and graded according to the Clavien-Dindo Classification system over a 30-day follow-up period. All complications will be documented daily during hospitalization and at scheduled follow-up visits, with particular attention to surgical site infections, anastomotic leakage, pulmonary complications, and prolonged ileus. This comprehensive assessment will enable detailed analysis of the relationship between preoperative sarcopenia and postoperative outcomes, potentially identifying high-risk patients who might benefit from preoperative optimization strategies.

    Measured: 30 days post-surgery

Secondary outcomes (3)
  1. Length of Hospital Stay

    The duration of hospitalization will be measured from the day of surgery until discharge, with standardized discharge criteria including adequate pain control, successful oral intake and return of bowel function

    Measured: 30 days post-surgery

  2. Return to Daily Activities

    The evaluation of the patients' return to their initial functional status will be evaluated using standardized questionnaires, either in person during outpatient clinic visits or over the phone (in cases where they do not come for regular follow-ups). This involves monitoring the time required to resume basic activities of daily living (ADLs) and reach preoperative functional capacity.

    Measured: 30 days post-surgery

  3. Wound Healing Assessment

    Comprehensive wound healing evaluation will be conducted using standardized assessment tools and objective measurements throughout the 30-day postoperative period. Markers of wound healing will include inflammatory markers (C-reactive protein, white blood cell count), tissue oxygenation assessment, and time to suture/staple removal. The relationship between preoperative sarcopenia and wound healing complications will be analyzed, particularly focusing on the impact of reduced muscle mass and potential nutritional deficiencies on tissue repair and regeneration processes.

    Measured: 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2024
  2. Study start24 Nov 2024
  3. Primary completion9 Aug 2025
  4. Study completion1 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
70 participants (actual)
Target duration
1 Month
IDs, dates and publications
ClinicalTrials.gov ID
NCT06698289
Sponsor's protocol ID
CRC-SARCOPENIA-MUNIV2024
Status last verified
Mar 2026
First submitted
18 Nov 2024
Last updated
25 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share de-identified individual participant data underlying the study's primary and secondary outcomes. This includes demographic information (age, gender, BMI), clinical parameters (tumor staging, histology), sarcopenia assessment data (SARC-F scores, grip strength, walking tests, CT measurements), surgical details, and postoperative outcomes.

Publications

  • Yilmaz M, Barcin M, Tuna S, Koc HB, Bozkurt ME, Aslan G, Ozcan C, Bozkurt H, Colak T. Prevalence of preoperative sarcopenia according to EWGSOP2 in patients with colorectal cancer and its impact on surgical outcomes: a prospective observational study. BMC Surg. 2026 Jun 11. doi: 10.1186/s12893-026-03935-8. Online ahead of print.

    PubMed 42277777

Questions about this trial

What is this clinical trial studying?

An observational study of Sarcopenia and Colon Cancer, run by Mersin University at 1 site in Turkey (Türkiye).

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 5 inclusion and 3 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 25 Mar 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 Turkey (Türkiye). 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?

Postoperative Complications (time frame: 30 days post-surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06698289, which also lists 1 linked publication.

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 25 Mar 2026.

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