SurgeryNCT06657599
Malnutrition is a Severe Health Issue for Cancer Patients. This Study Examines How Preoperative Nutritional Status Affects Postoperative Delirium in Patients Undergoing Major Abdominal Surgery for Gynecological and Gastrointestinal Tumors.
An observational study of Surgery and Malnutrition, run by Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The World Health Organization (WHO) identifies malnutrition as a significant public health threat. It is a common issue among cancer patients due to various factors. Specific nutrient deficiencies can lead to severe cognitive problems. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Malnutrition, Delirium, Postoperative
- What is being tested?
- Major Abdominal Surgery
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2017to 1 Aug 2018
- How long will I take part?
- 1 Day
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing major abdominal surgery, have gynecological and GIS tumor, expected to stay in postoperative care unit for more than 24 hours.
Who may be able to join
- ASA I-IV
- Over 18 years of age
- Undergoing major abdominal surgery for gynecological and GIS tumor
- Expected to stay in postoperative care unit for more than 24 hours
Who cannot join
- Under age 18.
- Patients scheduled for emergency surgery, pregnancy, who want to withdraw from postoperative work.
- Patients with dementia, Alzheimer, psychiatric illness, illiterate people.
- Patients with speech, vision and hearing problems.
- Patients with a history of alcoholism.
- Patients who need postoperative mechanical ventilation support (patients who develop heart or respiratory failure due to COPD, heart failure, pulmonary embolism and similar reasons)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Malnutrition is a Severe Health Issue for Cancer Patients. This Study Examines How Preoperative Nutritional Status Affects Postoperative Delirium in Patients Undergoing Major Abdominal Surgery for Gynecological and Gastrointestinal Tumors. the Study Highlights the Critical Role of Preoperative Malnutrition in Delirium and Recommends That All Patients Scheduled for Major Abdominal Surgery Be Evaluated for Nutritional Status At the Outset.
The World Health Organization (WHO) identifies malnutrition as a significant public health threat. It is a common issue among cancer patients due to various factors. Specific nutrient deficiencies can lead to severe cognitive problems. This study aims to evaluate the impact of preoperative nutritional status on the frequency of postoperative delirium. Additionally, we will compare different parameters that can be used to diagnose preoperative malnutrition.
We included a total of 120 patients aged over 18 years, classified as ASA I-IV, who were undergoing major abdominal surgery for gynecological or gastrointestinal tumors and were expected to remain in the postoperative care unit for more than 24 hours. The patients' preoperative scores, albumin levels, prealbumin levels, and other relevant data were recorded. In the first 24 hours post-surgery, delirium was assessed using the Ramsay Sedation Scale and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
- Conditions
- Surgery, Malnutrition, Delirium, Postoperative, Abdominal Neoplasm
- Being tested
- Major Abdominal Surgery
- Medical subject headings
- Malnutrition, Emergence Delirium, Abdominal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Major Abdominal SurgeryProcedure or surgery
Patients with ASA I-IV, over 18 years of age, undergoing major abdominal surgery, have gynecological and GIS tumor, expected to stay in postoperative care unit for more than 24 hours.
What is being measured
The primary outcome is the main question the study is designed to answer.
CAM-ICU
The confusion assessment method for the intensive care unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start1 Jun 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozlem Sen, Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657599
- Sponsor's protocol ID
- Hazel06
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Malnutrition is a Severe Health Issue for Cancer Patients. This Study Examines How Preoperative Nutritional Status Affects Postoperative Delirium in Patients Undergoing Major Abdominal Surgery for Gynecological and Gastrointestinal Tumors. the Study Highlights the Critical Role of Preoperative Malnutrition in Delirium and Recommends That All Patients Scheduled for Major Abdominal Surgery Be Evaluated for Nutritional Status At the Outset.
- ClinicalTrials.gov ID
- NCT06657599
- Acronym / sponsor ID
- Hazel06
- Conditions
- Surgery, Malnutrition, Delirium, Postoperative, Abdominal Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 24 Oct 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.
The World Health Organization (WHO) identifies malnutrition as a significant public health threat. It is a common issue among cancer patients due to various factors. Specific nutrient deficiencies can lead to severe cognitive problems. This study aims to evaluate the impact of preoperative nutritional status on the frequency of postoperative delirium. Additionally, we will compare different parameters that can be used to diagnose preoperative malnutrition.
We included a total of 120 patients aged over 18 years, classified as ASA I-IV, who were undergoing major abdominal surgery for gynecological or gastrointestinal tumors and were expected to remain in the postoperative care unit for more than 24 hours. The patients' preoperative scores, albumin levels, prealbumin levels, and other relevant data were recorded. In the first 24 hours post-surgery, delirium was assessed using the Ramsay Sedation Scale and the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing major abdominal surgery, have gynecological and GIS tumor, expected to stay in postoperative care unit for more than 24 hours.
Key inclusion criteria (4 listed)
- ASA I-IV
- Over 18 years of age
- Undergoing major abdominal surgery for gynecological and GIS tumor
- Expected to stay in postoperative care unit for more than 24 hours
Key exclusion criteria (6 listed)
- Under age 18.
- Patients scheduled for emergency surgery, pregnancy, who want to withdraw from postoperative work.
- Patients with dementia, Alzheimer, psychiatric illness, illiterate people.
- Patients with speech, vision and hearing problems.
- Patients with a history of alcoholism.
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 |
|---|---|---|
| Major Abdominal SurgeryPatients with ASA I-IV, over 18 years of age, undergoing major abdominal surgery, have gynecological and GIS tumor, expected to stay in postoperative care unit for more than 24 hours. | Procedure or surgery | – |
Primary outcome
CAM-ICU
Time frame: 24 hours
The confusion assessment method for the intensive care unit (CAM-ICU) is a tool used to assess delirium among patients in the intensive care unit.
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 26 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Surgery and Malnutrition, 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 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: finished, as of the sponsor's last update on 26 Oct 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?
CAM-ICU (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Oct 2024.