Confusion PostoperativeNCT06603129
Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery
An observational study of Confusion Postoperative and Delirium, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Aim: We aimed to show the relationship between preoperative prognostic nutritional index and postoperative delirium in patients who had undergone gastrointestinal cancer surgery. Materials and Methods: Our study is a single-center, prospective, observational study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Confusion Postoperative, Delirium, Gastrointestinal Cancer
- What is being tested?
- prognostic nutritional index
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 15 Jun 2022
- 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: A total of 136 patients aged 18 years and older, who would undergo gastrointestinal cancer surgery and who could give voluntary consent, were included in the study.
Who may be able to join
- Patients aged 18 and over
- Patients who will undergo gastrointestinal cancer surgery
- Able to give voluntary consent
- ASA I-IV patients
Who cannot join
- Under 18 years old
- Those who do not agree to be included in the study
- Unconscious
- Hearing, sight and speech impaired
- Chronic alcohol user
- Patients with cognitive or psychiatric disorders such as known dementia, Parkinson's, Alzheimer's
- Patients who need postoperative mechanical ventilation support
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Relationship Between Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery
Aim:
We aimed to show the relationship between preoperative prognostic nutritional index and postoperative delirium in patients who had undergone gastrointestinal cancer surgery.
Read more
Materials and Methods:
Our study is a single-center, prospective, observational study. Routine preoperative anesthesia evaluation of all patients was performed and patient's age, sex, ASA physical score, body mass index (BMI), existing comorbid diseases, level of education, smoking status, cancer diagnosis, chemotherapy and radiotherapy history, type of surgery, past invasive interventions, concentration of hemoglobin and albumin, lymphocyte count, liver and kidney function tests were recorded. PNI score was calculated with the preoperative measurements. With the calculated PNI score, nutritional status was defined as normal (PNI ≥50), mild malnutrition (PNI 45-50), moderate-severe malnutrition (PNI 40-45), and severe (PNI <40) accordingly. The patients were then evaluated for the presence of delirium using the Confusion Assessment Method (CAM) for 3 days postoperatively.
Read the detailed description
Aim:
Malnutrition, common among gastrointestinal cancer patients, affects morbidity and mortality. Prognostic nutritional index (PNI) is an inflammation-based scoring that measures the nutritional and immunological status of patients and has been used to determine prognosis and predict postoperative complications. Postoperative delirium (POD) describes a neurocognitive complication that may occur after surgery and anesthesia. Most of the studies examining the relationship between PNI and POD are retrospective and the number of prospective large case series are insufficient.
In this study, we aimed to show the relationship between preoperative prognostic nutritional index and postoperative delirium in patients who had undergone gastrointestinal cancer surgery.
Materials and Methods:
Our study is a single-center, prospective, observational study. Routine preoperative anesthesia evaluation of all patients was performed and patient's age, sex, ASA physical score, body mass index (BMI), existing comorbid diseases, level of education, smoking status, cancer diagnosis, chemotherapy and radiotherapy history, type of surgery, past invasive interventions, concentration of hemoglobin and albumin, lymphocyte count, liver and kidney function tests were recorded. PNI score was calculated with the preoperative measurements. With the calculated PNI score, nutritional status was defined as normal (PNI ≥50), mild malnutrition (PNI 45-50), moderate-severe malnutrition (PNI 40-45), and severe (PNI <40) accordingly. The patients were then evaluated for the presence of delirium using the Confusion Assessment Method (CAM) for 3 days postoperatively.
- Being tested
- prognostic nutritional index
- Keywords
- confusion, delirium, gastrointestinal cancer, prognostic nutritional index
- Medical subject headings
- Delirium, Gastrointestinal Neoplasms, Malnutrition, Confusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prognostic nutritional indexDiagnostic test
Prognostic nutritional index is an inflammation-based scoring that measures the nutritional and immunological status of patients and has been used to determine prognosis and predict postoperative complications.
| Study group | Role | What they receive |
|---|---|---|
| Delirium Group | group that developed delirium within 3 days postoperatively Receives: Diagnostic Test: prognostic nutritional index | |
| Non Delirium Group | group that did not develop delirium within 3 days postoperatively Receives: Diagnostic Test: prognostic nutritional index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the development of delirium
Evaluation of whether delirium develops in postoperative patients within the first 3 days using the Confusion Assessment Method (CAM)
Measured: 15 October 2021-20 May 2022
Secondary outcomes (3)
demographic characteristics
Evaluation of patients' age, gender, education level and their relationship with delirium
Measured: 15 October 2021-15 June 2022
amount of bleeding
The relationship between the amount of bleeding and delirium
Measured: 15 October 2021-15 June 2022
biochemical parameters
Evaluation of the patients' lymphocyte count, hemoglobin, albumin, urea, creatinine, AST, ALT concentrations and their relationship with delirium
Measured: 15 October 2021-15 June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2021
- Primary completion20 May 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Confusion PostoperativeStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 134 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, Muhammet Aydın Akdoğan, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Investigators
- Gonca Oguz, Study director, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06603129
- Sponsor's protocol ID
- 2021-10/1411
- Status last verified
- Sep 2024
- First submitted
- 28 Sep 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Liu H, Dai M, Guan H, Gao X, Zhou Y, Sun X, Zhou J, Hu X, Li X, Song Y, Han Y, Cao J. Preoperative Prognostic Nutritional Index Value is Related to Postoperative Delirium in Elderly Patients After Noncardiac Surgery: A Retrospective Cohort Study. Risk Manag Healthc Policy. 2021 Jan 6;14:1-8. doi: 10.2147/RMHP.S280567. eCollection 2021.
PubMed 33442311
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Relationship Between Preoperative Prognostic Nutritional Index and Postoperative Delirium in Gastrointestinal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06603129
- Acronym / sponsor ID
- 2021-10/1411
- Keywords
- confusion, delirium, gastrointestinal cancer, prognostic nutritional index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 19 Sep 2024 (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.
Aim:
We aimed to show the relationship between preoperative prognostic nutritional index and postoperative delirium in patients who had undergone gastrointestinal cancer surgery.
Materials and Methods:
Our study is a single-center, prospective, observational study. Routine preoperative anesthesia evaluation of all patients was performed and patient's age, sex, ASA physical score, body mass index (BMI), existing comorbid diseases, level of education, smoking status, cancer diagnosis, chemotherapy and radiotherapy history, type of surgery, past invasive interventions, concentration of hemoglobin and albumin, lymphocyte count, liver and kidney function tests were recorded. PNI score was calculated with the preoperative measurements. With the calculated PNI score, nutritional status was defined as normal (PNI ≥50), mild malnutrition (PNI 45-50), moderate-severe malnutrition (PNI 40-45), and severe (PNI <40) accordingly. The patients were then evaluated for the presence of delirium using the Confusion Assessment Method (CAM) for 3 days postoperatively.
Detailed description
Aim:
Malnutrition, common among gastrointestinal cancer patients, affects morbidity and mortality. Prognostic nutritional index (PNI) is an inflammation-based scoring that measures the nutritional and immunological status of patients and has been used to determine prognosis and predict postoperative complications. Postoperative delirium (POD) describes a neurocognitive complication that may occur after surgery and anesthesia. Most of the studies examining the relationship between PNI and POD are retrospective and the number of prospective large case series are insufficient.
In this study, we aimed to show the relationship between preoperative prognostic nutritional index and postoperative delirium in patients who had undergone gastrointestinal cancer surgery.
Materials and Methods:
Our study is a single-center, prospective, observational study. Routine preoperative anesthesia evaluation of all patients was performed and patient's age, sex, ASA physical score, body mass index (BMI), existing comorbid diseases, level of education, smoking status, cancer diagnosis, chemotherapy and radiotherapy history, type of surgery, past invasive interventions, concentration of hemoglobin and albumin, lymphocyte count, liver and kidney function tests were recorded. PNI score was calculated with the preoperative measurements. With the calculated PNI score, nutritional status was defined as normal (PNI ≥50), mild malnutrition (PNI 45-50), moderate-severe malnutrition (PNI 40-45), and severe (PNI <40) accordingly. The patients were then evaluated for the presence of delirium using the Confusion Assessment Method (CAM) for 3 days postoperatively.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirium Group | – | Diagnostic Test: prognostic nutritional indexgroup that developed delirium within 3 days postoperatively |
| Non Delirium Group | – | Diagnostic Test: prognostic nutritional indexgroup that did not develop delirium within 3 days postoperatively |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 136 patients aged 18 years and older, who would undergo gastrointestinal cancer surgery and who could give voluntary consent, were included in the study.
Key inclusion criteria (4 listed)
- Patients aged 18 and over
- Patients who will undergo gastrointestinal cancer surgery
- Able to give voluntary consent
- ASA I-IV patients
Key exclusion criteria (7 listed)
- Under 18 years old
- Those who do not agree to be included in the study
- Unconscious
- Hearing, sight and speech impaired
- Chronic alcohol user
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 |
|---|---|---|
| prognostic nutritional indexPrognostic nutritional index is an inflammation-based scoring that measures the nutritional and immunological status of patients and has been used to determine prognosis and predict postoperative complications. | Diagnostic test | Delirium Group, Non Delirium Group |
Primary outcome
Evaluation of the development of delirium
Time frame: 15 October 2021-20 May 2022
Evaluation of whether delirium develops in postoperative patients within the first 3 days using the Confusion Assessment Method (CAM)
3 secondary outcomes
demographic characteristics
Time frame: 15 October 2021-15 June 2022
amount of bleeding
Time frame: 15 October 2021-15 June 2022
biochemical parameters
Time frame: 15 October 2021-15 June 2022
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 19 Sep 2024.
- Background: PubMed 33442311Liu H, Dai M, Guan H, Gao X, Zhou Y, Sun X, Zhou J, Hu X, Li X, Song Y, Han Y, Cao J. Preoperative Prognostic Nutritional Index Value is Related to Postoperative Delirium in Elderly Patients After Noncardiac Surgery: A Retrospective Cohort Study. Risk Manag Healthc Policy. 2021 Jan 6;14:1-8. doi: 10.2147/RMHP.S280567. eCollection 2021.
- Individual participant dataSharing planned: Undecided
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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.
Gonca Oguz study director
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
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 Confusion Postoperative and Delirium, 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 4 inclusion and 7 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 19 Sep 2024. 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?
Evaluation of the development of delirium (time frame: 15 October 2021-20 May 2022). 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 NCT06603129, which also lists 1 linked publication.
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 19 Sep 2024.