Postoperative ComplicationsNCT06866678
Frailty Score and Postoperative Morbidity in Colorectal Cancer Surgery
An observational study of Postoperative Complications and Colorectal Cancer, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective observational study aims to evaluate the independent predictive value of the Edmonton Frailty Index (EFI) in estimating postoperative morbidity among older patients undergoing elective colorectal cancer surgery. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications, Colorectal Cancer, Frailty
- What is being tested?
- Observational Data Collection
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2025to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective, observational study to be conducted between February 20, 2025, and June 1, 2025, in the General Surgery and Surgical Oncology departments of our hospital. The study population will consist of patients aged 18 years and older undergoing elective colorectal cancer surgery. Data will be collected from preoperative frailty assessments using the Edmonton Frailty Scale (EFS), anesthesia records, and postoperative follow-up documents
Who may be able to join
- Patients aged 65 years and older
- Patients undergoing surgery for colorectal cancer
- Patients scheduled for elective (non-emergency) surgery
- Individuals eligible for preoperative frailty assessment using the Edmonton Frailty Scale (EFS)
- Patients who can be followed for at least 30 days postoperatively
- Patients able to provide informed consent
Who cannot join
- Patients requiring emergency surgery
- Neurological or psychiatric disorders that prevent the assessment of consciousness level
- Severe comorbidities (Patients with extremely high surgical risk due to severe cardiovascular, respiratory, or other systemic diseases)
- Patients who do not or cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Abdurrahman Yurtaslan Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Rea
Ankara, Yenimahalle, 06200
About this study
Official title: Can the Frailty Score Independently Predict Surgical Risk and Postoperative Morbidity in Patients With Colorectal Cancer?
This prospective observational study aims to evaluate the independent predictive value of the Edmonton Frailty Index (EFI) in estimating postoperative morbidity among older patients undergoing elective colorectal cancer surgery. Frailty, characterized by a decline in physiological reserves and increased vulnerability to stressors, has been recognized as a stronger predictor of adverse postoperative outcomes than chronological age alone. While the relationship between frailty and surgical outcomes has been extensively investigated in general surgical populations, data specifically focusing on patients with colorectal cancer remain limited.
In this study, patients aged 65 years and older scheduled for elective colorectal cancer surgery will undergo preoperative frailty assessment using the validated Edmonton Frailty Index (EFI). Postoperative complications, length of intensive care unit (ICU) stay, total hospital stay, and 30-day adverse outcomes, including mortality, myocardial infarction, pulmonary embolism, sepsis, and the need for reoperation, will be recorded and analyzed.
Read more
The primary objective is to determine whether frailty, as measured by the Edmonton Frailty Index, serves as an independent predictor of postoperative morbidity in this specific patient population. Secondary objectives include exploring associations between frailty and intraoperative variables such as blood loss, fluid administration, and vasopressor requirements.
By addressing this gap, the study aims to contribute to the growing body of evidence supporting the routine incorporation of frailty assessment into preoperative risk stratification protocols for older patients with colorectal cancer. The ultimate goal is to enhance perioperative risk assessment, optimize perioperative care, and improve patient outcomes.
Read the detailed description
This prospective, observational study aims to evaluate whether the Frailty Risk Index (FRI) can independently predict postoperative morbidity in patients undergoing elective surgery for colorectal cancer. Frailty is a clinical syndrome characterized by decreased physiological reserve and increased vulnerability to stressors, particularly in elderly populations. Recent studies have demonstrated that frailty is a better predictor of adverse postoperative outcomes than chronological age, especially among cancer patients and the elderly surgical population.
The study will be conducted at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Data will be collected from anesthesia records of patients who undergo elective colorectal cancer surgery in the General Surgery and Surgical Oncology clinics. The sample size was calculated based on the hypothesis that patients with a high Frailty Risk Score will have increased rates of postoperative morbidity. A minimum of 69 patients is required to achieve 90% power with a type I error rate of 0.05 and a medium effect size (0.5). To account for potential dropouts and missing data, a total of 80 patients will be included.
The primary objective is to assess the independent predictive value of the Frailty Risk Index for postoperative clinical outcomes in colorectal cancer patients. Secondary objectives include comparing postoperative complication rates, intensive care unit admissions, length of hospital stay, and 30-day adverse events (such as mortality, myocardial infarction, pulmonary embolism, and sepsis) between frail and non-frail patients.
Patients aged 65 years and older who are scheduled for elective colorectal cancer surgery and can be evaluated preoperatively with the FRI will be included. Exclusion criteria are emergency surgery, severe comorbidities that preclude surgery, neurological or psychiatric disorders that impair consciousness assessment, and inability or unwillingness to provide informed consent.
The Frailty Risk Index will be assessed based on five criteria: unintentional weight loss, self-reported exhaustion, weakness (reduced grip strength), slow walking speed, and low physical activity. Patients meeting three or more criteria will be classified as frail.
Data collection will include preoperative variables (age, sex, ASA score, comorbidities, diagnosis, metastasis status), intraoperative variables (anesthesia management, blood loss, fluid and blood product administration, vasopressor requirement), and postoperative outcomes (complications within 24 hours, ICU admission and stay, hospital length of stay, and adverse events within 30 days).
Statistical analysis will involve independent t-tests and chi-square tests for group comparisons, and multivariate logistic regression to assess the independent effect of the Frailty Risk Index on postoperative outcomes. A p-value of <0.05 will be considered statistically significant.
This study aims to fill a gap in the literature regarding the predictive value of frailty assessment in colorectal cancer surgery and to contribute to improved risk stratification and perioperative management in this patient population.
- Conditions
- Postoperative Complications, Colorectal Cancer, Frailty
- Being tested
- Observational Data Collection
- Medical subject headings
- Postoperative Complications, Colorectal Neoplasms, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational Data CollectionProcedure or surgery
No intervention will be performed as part of this study. This is an observational study; all patients will receive standard perioperative care according to current clinical practice. The study will only observe and record data related to frailty status and postoperative outcomes in patients undergoing elective colorectal cancer surgery. No experimental procedures, drugs, or additional interventions will be administered.
| Study group | Role | What they receive |
|---|---|---|
| Frail | Patients aged 65 years and older undergoing elective colorectal cancer surgery who meet three or more criteria on the Frailty Risk Index (FRI), and are classified as frail. These patients are expected to have increased vulnerability to postoperative complications. Receives: Procedure: Observational Data Collection | |
| Non-Frail | Patients aged 65 years and older undergoing elective colorectal cancer surgery who meet fewer than three criteria on the Frailty Risk Index (FRI), and are classified as non-frail. These patients are expected to have lower risk for postoperative complications compared to the frail group. Receives: Procedure: Observational Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complication Rate Postoperative Complication Rate (Clavien-Dindo ≥ Grade II)
The primary outcome is the incidence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo Classification System (Grade II and above). The relationship between preoperative frailty status, measured using the Edmonton Frailty Scale (EFS), and the development of postoperative complications will be assessed.
Measured: 30 days after surgery
Secondary outcomes (7)
Postoperative Mortality
All-cause mortality within 30 days after surgery
Measured: 30 days after surgery
Length of Hospital Stay
Total length of postoperative hospital stay (in days)
Measured: From surgery to hospital discharge (up to 30 days)
ICU Admission and Length of Stay
Requirement for ICU admission and duration of ICU stay (in days)
Measured: From surgery to hospital discharge (up to 30 days)
Surgical Site Infection
Incidence of surgical site infections (SSI) within 30 days after surgery
Measured: 30 days after surgery
Unplanned Reoperation
Incidence of unplanned reoperations within 30 days after surgery
Measured: 30 days after surgery
Unplanned Readmission
Incidence of unplanned readmission within 30 days of hospital discharge
Measured: 30 days after discharge
Postoperative Delirium
Incidence of postoperative delirium during hospitalization
Measured: During hospital stay (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2025
- Study start2 Mar 2025
- Primary completion10 Sep 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Kemal ŞAHİN, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Mustafa Kemal SAHIN, Principal investigator, Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06866678
- Sponsor's protocol ID
- 2025-02/28
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2025
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schmucker AM, Hupert N, Mandl LA. The Impact of Frailty on Short-Term Outcomes After Elective Hip and Knee Arthroplasty in Older Adults: A Systematic Review. Geriatr Orthop Surg Rehabil. 2019 May 6;10:2151459319835109. doi: 10.1177/2151459319835109. eCollection 2019.
PubMed 31105984Giger AW, Ditzel HM, Ewertz M, Ditzel H, Jorgensen TL, Pfeiffer P, Lund C, Ryg J. Effect of comprehensive geriatric assessment on hospitalizations in older adults with frailty initiating curatively intended oncologic treatment: The PROGNOSIS-RCT study. J Geriatr Oncol. 2024 Sep;15(7):101821. doi: 10.1016/j.jgo.2024.101821. Epub 2024 Jul 20.
PubMed 39034167Aucoin SD, Hao M, Sohi R, Shaw J, Bentov I, Walker D, McIsaac DI. Accuracy and Feasibility of Clinically Applied Frailty Instruments before Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2020 Jul;133(1):78-95. doi: 10.1097/ALN.0000000000003257.
PubMed 32243326Elsamadicy AA, Freedman IG, Koo AB, David WB, Reeves BC, Havlik J, Pennington Z, Kolb L, Shin JH, Sciubba DM. Modified-frailty index does not independently predict complications, hospital length of stay or 30-day readmission rates following posterior lumbar decompression and fusion for spondylolisthesis. Spine J. 2021 Nov;21(11):1812-1821. doi: 10.1016/j.spinee.2021.05.011. Epub 2021 May 16.
PubMed 34010683Cook MJ, Lunt M, Ashcroft DM, Board T, O'Neill TW. The impact of frailty on patient-reported outcomes following hip and knee arthroplasty. Age Ageing. 2022 Dec 5;51(12):afac288. doi: 10.1093/ageing/afac288.
PubMed 36571779Panayi AC, Orkaby AR, Sakthivel D, Endo Y, Varon D, Roh D, Orgill DP, Neppl RL, Javedan H, Bhasin S, Sinha I. Impact of frailty on outcomes in surgical patients: A systematic review and meta-analysis. Am J Surg. 2019 Aug;218(2):393-400. doi: 10.1016/j.amjsurg.2018.11.020. Epub 2018 Nov 27.
PubMed 30509455Sahin MK, Yilmaz B, Timuroglu A. Can the frailty score independently predict postoperative morbidity in patients with colorectal cancer? A prospective observational study. BMC Geriatr. 2026 Feb 27;26(1):461. doi: 10.1186/s12877-026-07255-7.
PubMed 41761087
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Frailty Score Independently Predict Surgical Risk and Postoperative Morbidity in Patients With Colorectal Cancer?
- ClinicalTrials.gov ID
- NCT06866678
- Acronym / sponsor ID
- 2025-02/28
- Conditions
- Postoperative Complications, Colorectal Cancer, Frailty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 10 Mar 2025 (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.
This prospective observational study aims to evaluate the independent predictive value of the Edmonton Frailty Index (EFI) in estimating postoperative morbidity among older patients undergoing elective colorectal cancer surgery. Frailty, characterized by a decline in physiological reserves and increased vulnerability to stressors, has been recognized as a stronger predictor of adverse postoperative outcomes than chronological age alone. While the relationship between frailty and surgical outcomes has been extensively investigated in general surgical populations, data specifically focusing on patients with colorectal cancer remain limited.
In this study, patients aged 65 years and older scheduled for elective colorectal cancer surgery will undergo preoperative frailty assessment using the validated Edmonton Frailty Index (EFI). Postoperative complications, length of intensive care unit (ICU) stay, total hospital stay, and 30-day adverse outcomes, including mortality, myocardial infarction, pulmonary embolism, sepsis, and the need for reoperation, will be recorded and analyzed.
The primary objective is to determine whether frailty, as measured by the Edmonton Frailty Index, serves as an independent predictor of postoperative morbidity in this specific patient population. Secondary objectives include exploring associations between frailty and intraoperative variables such as blood loss, fluid administration, and vasopressor requirements.
By addressing this gap, the study aims to contribute to the growing body of evidence supporting the routine incorporation of frailty assessment into preoperative risk stratification protocols for older patients with colorectal cancer. The ultimate goal is to enhance perioperative risk assessment, optimize perioperative care, and improve patient outcomes.
Detailed description
This prospective, observational study aims to evaluate whether the Frailty Risk Index (FRI) can independently predict postoperative morbidity in patients undergoing elective surgery for colorectal cancer. Frailty is a clinical syndrome characterized by decreased physiological reserve and increased vulnerability to stressors, particularly in elderly populations. Recent studies have demonstrated that frailty is a better predictor of adverse postoperative outcomes than chronological age, especially among cancer patients and the elderly surgical population.
The study will be conducted at Dr. Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital. Data will be collected from anesthesia records of patients who undergo elective colorectal cancer surgery in the General Surgery and Surgical Oncology clinics. The sample size was calculated based on the hypothesis that patients with a high Frailty Risk Score will have increased rates of postoperative morbidity. A minimum of 69 patients is required to achieve 90% power with a type I error rate of 0.05 and a medium effect size (0.5). To account for potential dropouts and missing data, a total of 80 patients will be included.
The primary objective is to assess the independent predictive value of the Frailty Risk Index for postoperative clinical outcomes in colorectal cancer patients. Secondary objectives include comparing postoperative complication rates, intensive care unit admissions, length of hospital stay, and 30-day adverse events (such as mortality, myocardial infarction, pulmonary embolism, and sepsis) between frail and non-frail patients.
Patients aged 65 years and older who are scheduled for elective colorectal cancer surgery and can be evaluated preoperatively with the FRI will be included. Exclusion criteria are emergency surgery, severe comorbidities that preclude surgery, neurological or psychiatric disorders that impair consciousness assessment, and inability or unwillingness to provide informed consent.
The Frailty Risk Index will be assessed based on five criteria: unintentional weight loss, self-reported exhaustion, weakness (reduced grip strength), slow walking speed, and low physical activity. Patients meeting three or more criteria will be classified as frail.
Data collection will include preoperative variables (age, sex, ASA score, comorbidities, diagnosis, metastasis status), intraoperative variables (anesthesia management, blood loss, fluid and blood product administration, vasopressor requirement), and postoperative outcomes (complications within 24 hours, ICU admission and stay, hospital length of stay, and adverse events within 30 days).
Statistical analysis will involve independent t-tests and chi-square tests for group comparisons, and multivariate logistic regression to assess the independent effect of the Frailty Risk Index on postoperative outcomes. A p-value of <0.05 will be considered statistically significant.
This study aims to fill a gap in the literature regarding the predictive value of frailty assessment in colorectal cancer surgery and to contribute to improved risk stratification and perioperative management in this patient population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frail | – | Procedure: Observational Data CollectionPatients aged 65 years and older undergoing elective colorectal cancer surgery who meet three or more criteria on the Frailty Risk Index (FRI), and are classified as frail. These patients are expected to have increased vulnerability to postoperative complications. |
| Non-Frail | – | Procedure: Observational Data CollectionPatients aged 65 years and older undergoing elective colorectal cancer surgery who meet fewer than three criteria on the Frailty Risk Index (FRI), and are classified as non-frail. These patients are expected to have lower risk for postoperative complications compared to the frail group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, observational study to be conducted between February 20, 2025, and June 1, 2025, in the General Surgery and Surgical Oncology departments of our hospital. The study population will consist of patients aged 18 years and older undergoing elective colorectal cancer surgery. Data will be collected from preoperative frailty assessments using the Edmonton Frailty Scale (EFS), anesthesia records, and postoperative follow-up documents
Key inclusion criteria (6 listed)
- Patients aged 65 years and older
- Patients undergoing surgery for colorectal cancer
- Patients scheduled for elective (non-emergency) surgery
- Individuals eligible for preoperative frailty assessment using the Edmonton Frailty Scale (EFS)
- Patients who can be followed for at least 30 days postoperatively
Key exclusion criteria (4 listed)
- Patients requiring emergency surgery
- Neurological or psychiatric disorders that prevent the assessment of consciousness level
- Severe comorbidities (Patients with extremely high surgical risk due to severe cardiovascular, respiratory, or other systemic diseases)
- Patients who do not or cannot provide informed consent
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 |
|---|---|---|
| Observational Data CollectionNo intervention will be performed as part of this study. This is an observational study; all patients will receive standard perioperative care according to current clinical practice. The study will only observe and record data related to frailty status and postoperative outcomes in patients undergoing elective colorectal cancer surgery. No experimental procedures, drugs, or additional interventions will be administered. | Procedure or surgery | Frail, Non-Frail |
Primary outcome
Postoperative Complication Rate Postoperative Complication Rate (Clavien-Dindo ≥ Grade II)
Time frame: 30 days after surgery
The primary outcome is the incidence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo Classification System (Grade II and above). The relationship between preoperative frailty status, measured using the Edmonton Frailty Scale (EFS), and the development of postoperative complications will be assessed.
7 secondary outcomes
Postoperative Mortality
Time frame: 30 days after surgery
Length of Hospital Stay
Time frame: From surgery to hospital discharge (up to 30 days)
ICU Admission and Length of Stay
Time frame: From surgery to hospital discharge (up to 30 days)
Surgical Site Infection
Time frame: 30 days after surgery
Unplanned Reoperation
Time frame: 30 days after surgery
Unplanned Readmission
Time frame: 30 days after discharge
Postoperative Delirium
Time frame: During hospital stay (up to 14 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Background: PubMed 31105984Schmucker AM, Hupert N, Mandl LA. The Impact of Frailty on Short-Term Outcomes After Elective Hip and Knee Arthroplasty in Older Adults: A Systematic Review. Geriatr Orthop Surg Rehabil. 2019 May 6;10:2151459319835109. doi: 10.1177/2151459319835109. eCollection 2019.
- Background: PubMed 39034167Giger AW, Ditzel HM, Ewertz M, Ditzel H, Jorgensen TL, Pfeiffer P, Lund C, Ryg J. Effect of comprehensive geriatric assessment on hospitalizations in older adults with frailty initiating curatively intended oncologic treatment: The PROGNOSIS-RCT study. J Geriatr Oncol. 2024 Sep;15(7):101821. doi: 10.1016/j.jgo.2024.101821. Epub 2024 Jul 20.
- Background: PubMed 32243326Aucoin SD, Hao M, Sohi R, Shaw J, Bentov I, Walker D, McIsaac DI. Accuracy and Feasibility of Clinically Applied Frailty Instruments before Surgery: A Systematic Review and Meta-analysis. Anesthesiology. 2020 Jul;133(1):78-95. doi: 10.1097/ALN.0000000000003257.
- Background: PubMed 34010683Elsamadicy AA, Freedman IG, Koo AB, David WB, Reeves BC, Havlik J, Pennington Z, Kolb L, Shin JH, Sciubba DM. Modified-frailty index does not independently predict complications, hospital length of stay or 30-day readmission rates following posterior lumbar decompression and fusion for spondylolisthesis. Spine J. 2021 Nov;21(11):1812-1821. doi: 10.1016/j.spinee.2021.05.011. Epub 2021 May 16.
- Background: PubMed 36571779Cook MJ, Lunt M, Ashcroft DM, Board T, O'Neill TW. The impact of frailty on patient-reported outcomes following hip and knee arthroplasty. Age Ageing. 2022 Dec 5;51(12):afac288. doi: 10.1093/ageing/afac288.
- Background: PubMed 30509455Panayi AC, Orkaby AR, Sakthivel D, Endo Y, Varon D, Roh D, Orgill DP, Neppl RL, Javedan H, Bhasin S, Sinha I. Impact of frailty on outcomes in surgical patients: A systematic review and meta-analysis. Am J Surg. 2019 Aug;218(2):393-400. doi: 10.1016/j.amjsurg.2018.11.020. Epub 2018 Nov 27.
- Derived from this study: PubMed 41761087Sahin MK, Yilmaz B, Timuroglu A. Can the frailty score independently predict postoperative morbidity in patients with colorectal cancer? A prospective observational study. BMC Geriatr. 2026 Feb 27;26(1):461. doi: 10.1186/s12877-026-07255-7.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mustafa Kemal SAHIN principal investigator
Ankara Oncology Education and Research Hospital Clinic of Anesthesiology and Reanimation
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 Postoperative Complications and Colorectal Cancer, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 30 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Complication Rate Postoperative Complication Rate (Clavien-Dindo ≥ Grade II) (time frame: 30 days after surgery). 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 NCT06866678, which also lists 7 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 30 Apr 2026.