Preoperative Sarcopenia and Surgical Outcomes in Colorectal Cancer Patients

NCT06698289 | Completed

• 1 other identifier: CRC-SARCOPENIA-MUNIV2024
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Rectal Cancer; Surgical Outcomes; Sarcopenia; Colon Cancer

Outcome Measures

Primary Outcomes (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.

  30 days post-surgery

Secondary Outcomes (3)

• Length of Hospital Stay

  30 days post-surgery

• Return to Daily Activities

  30 days post-surgery

• Wound Healing Assessment

  30 days post-surgery

Study Arms (2)

Sarcopenia

Patients 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-sarcopenia

Patients 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.

Eligibility Criteria

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

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sarcopenia; Colonic Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Mustafa Yılmaz

  Mersin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 20, 2024
• Study Start: November 24, 2024
• Primary Completion: August 9, 2025
• Study Completion: January 1, 2026
• Last Updated: March 25, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication. Data access will be granted to researchers who provide a methodologically sound proposal and have received approval from an independent review committee. Proposals should be directed to the General Surgery Department of Mersin University Hospital.
• Access Criteria: To gain access, researchers will need to sign a data access agreement and obtain relevant ethics approval if required. The study protocol, statistical analysis plan, informed consent form, and clinical study report will also be made available. Data will be shared through a secure online platform, with appropriate privacy and security safeguards in place.

Locations

TU (1)