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Recruiting NCT07529301

Functional and Respiratory Predictors of Early Postoperative Outcomes

— Observational Colorectal Cancer Functional Status Respiratory Parameters Clinical Outcomes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preoperative Assessments, Postoperative Assessments (Daily from Postoperative Day 1 Until Discharge).
Who it may be relevant to
Registry conditions: Colorectal Cancer, Functional Status, Respiratory Parameters, Clinical Outcomes. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Effect of Functional Status and Respiratory Parameters on Early Postoperative Clinical Outcomes in Patients With Colorectal Cancer

Overview

Functional status is a fundamental indicator reflecting a patient's ability to perform activities of daily living and is closely associated with early postoperative outcomes. Patients with low functional capacity are known to have an increased risk of postoperative complications, prolonged length of hospital stay, and higher mortality rates. Similarly, respiratory function plays a decisive role in the development of postoperative complications and influences early surgical outcomes. In the preoperative period, inadequate respiratory capacity and poor functional performance increase the risk of postoperative pulmonary complications and delayed recovery. Therefore, functional and respiratory assessments are regarded as integral components of the preoperative preparation process. Early outcomes in patients undergoing colorectal cancer surgery are of critical importance in reducing mortality and morbidity. In this surgical population, advanced age, comorbidities, and diminished physical capacity may further increase the risk of postoperative complications. Accordingly, the evaluation of preoperative functional status and physiological reserve has gained increasing importance for risk stratification and perioperative management. However, studies examining the impact of functional status and respiratory parameters on early surgical outcomes in patients with colorectal cancer remain limited. Consequently, the available evidence is insufficient to establish a standardized assessment approach in clinical practice. Moreover, objective evaluation of patients' functional and respiratory capacities in the preoperative period is essential for predicting surgical risk and planning individualized perioperative care. Determining the relationships between these parameters and early clinical outcomes may facilitate the identification of high-risk patients and contribute to the development of targeted strategies aimed at preventing postoperative complications. Findings obtained in this context are expected to provide a scientific basis for clinical decision-making and multidisciplinary patient management in individuals undergoing colorectal cancer surgery, thereby guiding clinical practice.

Interventions

  • Other Preoperative Assessments
    Preoperative Assessments Sociodemographic and Clinical Characteristics Sociodemographic and clinical characteristics of the patients will be recorded. Respiratory Function Respiratory function will be measured using standard spirometric evaluation methods. Forced expiratory volume in one second (FEV₁), forced vital capacity (FVC), and peak expiratory flow (PEF) values will be recorded. Physical Activity Level Physical activity level will be assessed using the International Physical Activity Q
  • Other Postoperative Assessments (Daily from Postoperative Day 1 Until Discharge)
    Pain severity will be assessed using the McGill-Melzack Pain Questionnaire. The total pain score will be recorded. Patient Mobility Patient mobility will be assessed using the Patient Mobility Scale. Quality of Recovery Postoperative recovery quality will be evaluated using the Quality of Recovery-40 (QoR-40) questionnaire. The total score will be recorded. Daily Analgesic Consumption The amount of daily analgesic use will be recorded. Daily Flatus and Defecation The frequency and timing of

Primary outcome measures

  • Short Physical Performance Battery (SPPB) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

Being between 18 and 80 years of age

Voluntary agreement to participate in the study

Exclusion criteria

Withdrawal from the study at the participant's own request

Elimination Criteria

Presence of a musculoskeletal condition that may prevent completion of the planned assessments

Presence of a mental impairment

History of psychiatric disorder

History of previous major surgery

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Turkey (Türkiye) · 1 center
  • İnönü University Turgut Özal Medical Center General Surgery Polyclinic — Malatya

Publications

  • Mao JX, Gao R, Wang Y, Yan XB, Wang HH. Surgical treatment of colorectal cancer: A multidimensional review. World J Gastrointest Surg. 2025 Aug 27;17(8):107785. doi: 10.4240/wjgs.v17.i8.107785. PMID 40949364
  • Pickhardt PJ, Hassan C, Halligan S, Marmo R. Colorectal cancer: CT colonography and colonoscopy for detection--systematic review and meta-analysis. Radiology. 2011 May;259(2):393-405. doi: 10.1148/radiol.11101887. Epub 2011 Mar 17. PMID 21415247
  • Toma M, Belusica L, Stavarachi M, Apostol P, Spandole S, Radu I, Cimponeriu D. Rating the environmental and genetic risk factors for colorectal cancer. J Med Life. 2012 Oct-Dec;5(Spec Issue):152-159. PMID 31803304
  • Carr PR, Weigl K, Jansen L, Walter V, Erben V, Chang-Claude J, Brenner H, Hoffmeister M. Healthy Lifestyle Factors Associated With Lower Risk of Colorectal Cancer Irrespective of Genetic Risk. Gastroenterology. 2018 Dec;155(6):1805-1815.e5. doi: 10.1053/j.gastro.2018.08.044. Epub 2018 Sep 8. PMID 30201362
  • Tomruk M, Karadibak D, Yavuzsen T, Akman T. Predictors of functional capacity in colorectal cancer patients. Support Care Cancer. 2015 Sep;23(9):2747-54. doi: 10.1007/s00520-015-2639-3. Epub 2015 Feb 8. PMID 25663544
  • van Rooijen S, Carli F, Dalton S, Thomas G, Bojesen R, Le Guen M, Barizien N, Awasthi R, Minnella E, Beijer S, Martinez-Palli G, van Lieshout R, Gogenur I, Feo C, Johansen C, Scheede-Bergdahl C, Roumen R, Schep G, Slooter G. Multimodal prehabilitation in colorectal cancer patients to improve functional capacity and reduce postoperative complications: the first international randomized controlled t PMID 30670009
  • Whelan M, van Aswegen H, Roos R, Fabian J, Bebington B. Preoperative physical activity and functional performance levels are predictors of acute postoperative outcomes in a private South African colorectal cancer cohort. S Afr J Physiother. 2021 Aug 4;77(1):1526. doi: 10.4102/sajp.v77i1.1526. eCollection 2021. PMID 34355106
  • Mima K, Kosumi K, Miyanari N, Tajiri T, Kanemitsu K, Takematsu T, Inoue M, Mizumoto T, Kubota T, Baba H. Impairment of Activities of Daily Living is an Independent Risk Factor for Recurrence and Mortality Following Curative Resection of Stage I-III Colorectal Cancer. J Gastrointest Surg. 2021 Oct;25(10):2628-2636. doi: 10.1007/s11605-021-04990-7. Epub 2021 Apr 6. PMID 33825120

Identifiers

NCT: NCT07529301 · 2026/9168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗