NCT07523919

Brief Summary

Colorectal cancer is one of the most commonly diagnosed malignancies worldwide and a leading cause of cancer-related morbidity and mortality. Its global incidence continues to increase, with a substantial proportion of cases diagnosed at advanced stages, which adversely affects prognosis. Patients diagnosed at an early stage and treated with surgery have significantly better long-term survival outcomes. Five-year survival rates are approximately 90% for stage I disease, decreasing to around 70% in stage II and 60% in stage III, and dropping to as low as 8% in stage IV disease. Advanced age, family history, and environmental exposures are well-established risk factors for colorectal cancer. In addition, modifiable lifestyle factors-including smoking, physical inactivity, unhealthy dietary patterns, and obesity-have been shown to significantly increase the risk of disease. Although surgical resection remains the cornerstone of curative treatment in colorectal cancer, long-term outcomes are influenced not only by tumor stage but also by various patient-related factors, including comorbidities, functional capacity, and respiratory reserve. Functional status, which reflects a patient's ability to perform activities of daily living, is a key determinant of postoperative recovery and long-term outcomes. Reduced functional capacity has been associated with poorer long-term survival, diminished quality of life, and increased late morbidity. Therefore, objective preoperative assessment of functional status is considered essential for predicting long-term prognosis. Respiratory function also plays a critical role, particularly in patients undergoing abdominal surgery. Impaired pulmonary capacity increases the risk of postoperative pulmonary complications, prolongs hospital stay, and may indirectly affect long-term survival. However, studies evaluating the impact of preoperative respiratory parameters on long-term outcomes in patients with colorectal cancer remain limited. Furthermore, comprehensive analyses integrating both functional capacity and respiratory function are scarce in the current literature. Therefore, further investigation in this area is warranted. The aim of this study is to evaluate the impact of functional status and respiratory parameters on long-term clinical outcomes in patients with colorectal cancer. H0: There is no statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer. H1: There is a statistically significant association between functional status, respiratory parameters, and long-term clinical outcomes in patients with colorectal cancer.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress8%
Mar 2026Mar 2028

Study Start

First participant enrolled

March 10, 2026

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

April 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2028

Last Updated

April 13, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

April 5, 2026

Last Update Submit

April 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Six-Minute Walk Test (6MWT)

    2 years

Study Arms (1)

Colorectal Cancer Patients

This cohort consists of patients with colorectal cancer undergoing surgical treatment. Functional status and respiratory parameters are assessed preoperatively, and patients are followed to evaluate long-term clinical outcomes. No additional intervention beyond standard care is performed.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients aged 18-80 years diagnosed with colorectal cancer and scheduled for surgical treatment. All participants undergo preoperative assessment, including evaluation of functional status and respiratory parameters such as the Six-Minute Walk Test (6MWT) and pulmonary function tests. Patients with conditions that may interfere with test performance, including significant musculoskeletal, cognitive, or psychiatric disorders, as well as those with a history of major surgery, are excluded. Participants are followed longitudinally to assess long-term clinical outcomes.

You may qualify if:

  • Age between 18 and 80 years
  • Voluntary participation in the study

You may not qualify if:

  • Presence of musculoskeletal disorders that may prevent completion of the required tests
  • Presence of cognitive impairment
  • History of psychiatric disease
  • History of major surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnönü University Turgut Özal Medical Center General Surgery Polyclinic

Merkez, Gümüşhane Province, 29000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 9. Mima, K., Kosumi, K., Miyanari, N., Tajiri, T., Kanemitsu, K., Takematsu, T., … Baba, H. (2021). Impairment of activities of daily living is an independent risk factor for recurrence and mortality following curative resection of stage I-III colorectal cancer. Journal of Gastrointestinal Surgery, 25(10), 2628-2636. 10. Overcash, J. (2015). Assessing the functional status of older cancer patients in an ambulatory care visit. Healthcare, 3(3), 846-859. 11. Takahashi, K., Chiba, K., Honda, A., Iizuka, Y., Yoshinaga, K., Deo, A. S., & Uchida, T. (2025). Pre-operative subjective functional capacity and postoperative outcomes in adult non-cardiac surgery: A systematic review and meta-analysis. Anaesthesia, 80(5), 561-571. 12. Wilson, I. B., & Cleary, P. D. (1995). Linking clinical variables with health-related quality of life: A conceptual model of patient outcomes. JAMA, 273(1), 59-65. 13. Minnella, E. M., Liberman, A. S., Charlebois, P., Stein, B., Scheede-Bergdahl, C., Awasthi, R., … Carli, F. (2019). The impact of improved functional capacity before surgery on postoperative complications: A study in colorectal cancer. Acta Oncologica, 58(5), 573-578. 14. Sánchez-Torralvo, F. J., González-Poveda, I., García-Olivares, M., Porras, N., Gonzalo-Marín, M., Tapia, M. J., … Olveira, G. (2022). Poor physical performance is associated with postoperative complications and mortality in preoperative patients with colorectal cancer. Nutrients, 14(7), 1484.

    RESULT
  • 1. Mao, J. X., Gao, R., Wang, Y., Yan, X. B., & Wang, H. H. (2025). Surgical treatment of colorectal cancer: A multidimensional review. World Journal of Gastrointestinal Surgery, 17(8), 107785. 2. Pickhardt, P. J., Kim, D. H., Pooler, B. D., Hinshaw, J. L., Barlow, D., & Mccoy, A. (2011). Colorectal cancer: CT colonography and colonoscopy for detection-Systematic review and meta-analysis. Radiology, 259(2), 393-405. 3. Toma, M., Beluşică, L., Stavarachi, M., Apostol, P., Spandole, S., Radu, I., & Cimponeriu, D. (2012). Rating the environmental and genetic risk factors for colorectal cancer. Journal of Medicine and Life, 5(Special Issue), 152-159. 4. Carr, P. R., Weigl, K., Jansen, L., Walter, V., Erben, V., Chang-Claude, J., Brenner, H., & Hoffmeister, M. (2018). Healthy lifestyle factors associated with lower risk of colorectal cancer irrespective of genetic risk. Gastroenterology, 155(6), 1805-1815.e5. 5. de Nes, L. C. F. (2025). Assessment and improvement of quality of care in colorectal cancer surgery (Doctoral dissertation). 6. Tomruk, M., Karadibak, D., Yavuzşen, T., & Akman, T. (2015). Predictors of functional capacity in colorectal cancer patients. Supportive Care in Cancer, 23(9), 2747-2754. 7. van Rooijen, S., Carli, F., Dalton, S., Thomas, G., Bojesen, R., Le Guen, M., … Slooter, G. (2019). Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: The first international randomized controlled trial for multimodal prehabilitation. BMC Cancer, 19(1), 98. 8. Whelan, M., van Aswegen, H., Roos, R., Fabian, J., & Bebington, B. (2021). Preoperative physical activity and functional performance levels are predictors of acute postoperative outcomes in a private South African colorectal cancer cohort. South African Journal of Physiotherapy, 77(1), 1526.

    RESULT

MeSH Terms

Conditions

Colorectal NeoplasmsRespiratory Aspiration

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Müşerref Ebru YALÇIN, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

April 5, 2026

First Posted

April 13, 2026

Study Start

March 10, 2026

Primary Completion (Estimated)

March 10, 2028

Study Completion (Estimated)

March 10, 2028

Last Updated

April 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations