NCT07529301

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
10mo left

Started Mar 2026

Shorter than P25 for all trials

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 Progress19%
Mar 2026Feb 2027

Study Start

First participant enrolled

March 1, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 14, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 25, 2027

Last Updated

April 14, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 4, 2026

Last Update Submit

April 9, 2026

Conditions

Keywords

Colorectal CancerFunctional StatusRespiratory ParametersClinical Outcomes

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPPB)

    Short Physical Performance Battery (SPPB): This scale is used to assess lower extremity physical performance. The total score ranges from 0 to 12, with higher scores indicating better physical performance.

    1 year

Interventions

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 Questionnaire-Short Form (IPAQ-SF). Physical Performance Physical performance will be evaluated using the Short Physical Performance Battery (SPPB). The SPPB consists of the 4-meter gait speed test, the chair stand test, and the standing balance test. The total score will be calculated. Ultrasonography Diaphragmatic muscle thickness will be measured using ultrasonography. Handgrip Strength Right- and left-hand grip strength will be measured using a hand dynamometer.

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 daily flatus and bowel movements will be recorded. Mobilization Daily mobilization duration, frequency, and mobilization distance (in meters) will be recorded.

Eligibility Criteria

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

Individuals aged between 18 and 80 years who have undergone colorectal cancer surgery and who voluntarily agree to participate in the study will be included.

You may qualify if:

  • Being between 18 and 80 years of age
  • Voluntary agreement to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İnönü University Turgut Özal Medical Center General Surgery Polyclinic

Malatya, Turkey (Türkiye)

RECRUITING

Related Publications (9)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 trial for multimodal prehabilitation. BMC Cancer. 2019 Jan 22;19(1):98. doi: 10.1186/s12885-018-5232-6.

  • 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.

  • 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.

  • Overcash J. Assessing the Functional Status of Older Cancer Patients in an Ambulatory Care Visit. Healthcare (Basel). 2015 Sep 18;3(3):846-59. doi: 10.3390/healthcare3030846.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Müşerref Ebru YALÇIN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

March 4, 2026

First Posted

April 14, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

August 25, 2026

Study Completion (Estimated)

February 25, 2027

Last Updated

April 14, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

The protection of patient data is of utmost importance to us.

Available IPD Datasets

Individual Participant Data Set Access

Locations