Colorectal CancerNCT07529301
Functional and Respiratory Predictors of Early Postoperative Outcomes
An observational study of Colorectal Cancer and Functional Status, run by Müşerref Ebru YALÇIN at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colorectal Cancer, Functional Status, Respiratory Parameters
- What is being tested?
- Preoperative Assessments and Postoperative Assessments (Daily from Postoperative Day 1 Until Discharge)
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2026to 25 Feb 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Being between 18 and 80 years of age
- Voluntary agreement to participate in the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
İnönü University Turgut Özal Medical Center General Surgery Polyclinic
Malatya
Egemen Çiçek
About this study
Official title: The Effect of Functional Status and Respiratory Parameters on Early Postoperative Clinical Outcomes in Patients With Colorectal Cancer
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.
- Being tested
- Preoperative Assessments, Postoperative Assessments (Daily from Postoperative Day 1 Until Discharge)
- Keywords
- Colorectal Cancer, Functional Status, Respiratory Parameters, Clinical Outcomes
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative AssessmentsOther
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.
Postoperative Assessments (Daily from Postoperative Day 1 Until Discharge)Other
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Mar 2026
- Primary completion25 Aug 2026 (estimated)
- Study completion25 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 42 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Müşerref Ebru YALÇIN
- Sponsor type
- University, hospital or other
- Collaborators
- Inonu University
- Responsible party
- Sponsor-investigator, Müşerref Ebru YALÇIN, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529301
- Sponsor's protocol ID
- 2026/9168
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protection of patient data is of utmost importance to us.
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.
PubMed 40949364Pickhardt 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.
PubMed 21415247Toma 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.
PubMed 31803304Carr 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.
PubMed 30201362Tomruk 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.
PubMed 25663544van 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.
PubMed 30670009Whelan 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.
PubMed 34355106Mima 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.
PubMed 33825120Overcash 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.
PubMed 27417801
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Functional Status and Respiratory Parameters on Early Postoperative Clinical Outcomes in Patients With Colorectal Cancer
- ClinicalTrials.gov ID
- NCT07529301
- Acronym / sponsor ID
- 2026/9168
- Keywords
- Colorectal Cancer, Functional Status, Respiratory Parameters, Clinical Outcomes
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Müşerref Ebru YALÇINUniversity, hospital or other
- Collaborators
- Inonu University
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 25 Aug 2026 (estimated)
- Study completion
- 25 Feb 2027 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Being between 18 and 80 years of age
- Voluntary agreement to participate in the study
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative AssessmentsPreoperative 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. | 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 daily flatus and bowel movements will be recorded. Mobilization Daily mobilization duration, frequency, and mobilization distance (in meters) will be recorded. | Other | – |
Primary outcome
Short Physical Performance Battery (SPPB)
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
- Results publication: PubMed 40949364Mao 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.
- Results publication: PubMed 21415247Pickhardt 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.
- Results publication: PubMed 31803304Toma 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.
- Results publication: PubMed 30201362Carr 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.
- Results publication: PubMed 25663544Tomruk 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.
- Results publication: PubMed 30670009van 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.
- Results publication: PubMed 34355106Whelan 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.
- Results publication: PubMed 33825120Mima 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.
- Results publication: PubMed 27417801Overcash 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.
- Individual participant dataSharing planned: No. The protection of patient data is of utmost importance to us.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Functional Status, run by Müşerref Ebru YALÇIN 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 14 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Müşerref Ebru YALÇIN (+90 555 713 6666, M.ebrusen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Physical Performance Battery (SPPB) (time frame: 1 year). 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 NCT07529301, which also lists 9 linked publications.
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 14 Apr 2026.