Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis.
Zoë Tieges, Alasdair M J Maclullich, Atul Anand...
https://pubmed.ncbi.nlm.nih.gov/33951145Actively Recruiting
Age: 18Years +
All Genders
ID06687291
Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
Led by Karolinska Institutet · Updated on 2025-07-02
130
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Karolinska Institutet
Lead Sponsor
R
Region Stockholm
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to investigate how often Post Operative Delirium (POD) occurs after surgery for gastric or esophageal cancer. It also explores the connection between POD and factors like preoperative depression, frailty, quality of life, malnutrition, and muscle loss (sarcopenia). Participants who experience POD will be invited for interviews to share their experiences. All participants will be assessed for cognitive function using the 4AT Test at several points: before chemotherapy if given, at hospital admission for surgery, on days 1, 3, and 7 after surgery, and again 4 to 8 weeks post-surgery. Researchers will also evaluate risk factors such as depression, frailty, nutrition status, and muscle loss using questionnaires, clinical scales, and CT scans conducted as part of routine care. Participants will complete questionnaires about their quality of life and undergo assessments for depression and frailty before surgery. Their nutritional status and muscle condition will be measured around the time of surgery. The main outcome is to track the incidence of POD from enrollment until about six months after surgery. The study includes routine follow-up visits and interviews to understand the patient experience and monitor health changes over time.
CONDITIONS
Brief Title
Cognitive Impact Associated With Surgery For Gastric Or Esophageal Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with esophageal or gastric cancer, treated with or without chemotherapy and surgery.
- Age 18 years or older at the time of inclusion.
- Willing to participate voluntarily and may end participation at any time.
- Able to give informed consent.
You will not qualify if you...
- Patients with preoperative cognitive dysfunction such as dementia.
- Patients inoperable due to metastases.
- Patients unable to communicate due to severely impaired hearing or vision.
- Patients with ongoing drug or alcohol abuse.
- Patients who cannot give informed consent.
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Diagnostic Evaluation
Duration - From enrollment to admission for surgery
Participants undergo cognitive function assessment using the 4AT Test before neoadjuvant chemotherapy (if indicated) and at admission for surgery to evaluate cognitive status and related risk factors.
1 baseline visit and 1 visit at admission for surgery
Surgery and Immediate Post-operative Care
Duration - First 7 days after surgery
Participants are assessed for cognitive impact using the 4AT Test on postoperative days 1, 3, and 7, monitoring for postoperative delirium and other related factors.
3 in-person visits during the first week after surgery
Post-operative Follow-up
Duration - Approximately 6 months after surgery
Participants are followed up for approximately 6 months after surgery to monitor the incidence of postoperative delirium, health-related quality of life, and other outcomes related to recovery.
Follow-up visits occurring 4 to 8 weeks after surgery and additional routine follow-up meetings
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital, Huddinge
Huddinge, Sweden, 14157
Actively Recruiting
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Research Team
M
Marcus Nömm, PhD-student
M
Maria Lampi, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Associated factors for postoperative delirium following major abdominal surgery: A systematic review and meta-analysis.
Jing Liu, Jianli Li, Jing Wang...
https://pubmed.ncbi.nlm.nih.gov/37260053Chemotherapy-related cognitive impairment in older patients with cancer.
Kah Poh Loh, Michelle C Janelsins, Supriya G Mohile...
https://pubmed.ncbi.nlm.nih.gov/27197918American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Delirium Prevention.
Christopher G Hughes, Christina S Boncyk, Deborah J Culley...
https://pubmed.ncbi.nlm.nih.gov/32022748