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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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The primary objective of this observational study is to investigate the incidence of Post Operative Delirium (POD) after gastroesophageal cancer surgery. Secondary objectives are to investigate the relationship between POD, preoperative depression, frailty, quality of life, malnutrition and sarcopenia.
Participants identified with POD will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview, in order to understand the participant's experience of postoperative delirium.
The main objective aims to answer:
What is the incidence of POD after gastroesophageal cancer surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants identified with postoperative delirium | Participants identified with postoperative delirium will be asked (at the routine follow-up meeting after surgery) to participate in an qualitative interview in order to understand the participant's experience of postoperative delirium. | ||
| CASE-study participants | All included participants in the CASE-study.
|
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of postoperative delirium | The assessment of cognitive function will be performed using the validated 4AT Test (4AT). Cognitive impact will be assessed at baseline before neoadjuvant chemotherapy (if chemotherapy is indicated) and at patient admission for surgery, postoperative day 1, 3 and 7, and at follow-up 4-8 weeks after surgery. | From enrollment to the follow up meeting after surgery, approximate 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Preoperative depression | A risk factor for postoperative delirium is preoperative depression. Depression will be measured preoperatively with the Patient Health Questionnaire (PHQ-9). | From enrollment to admission for surgery |
| Preoperative frailty |
| Measure | Description | Time Frame |
|---|---|---|
| Patients experience of Postoperative delirium | All participants that suffered from POD will be invited to participate in an interview, with a maximum number of 25 participants. A semi-structured one-on-one interview with the aim to describe patient experiences of POD will be used. The semi-structured interview technique allows the interviewer to ask probing questions for clarification when necessary. An interview guide will be used to ensure covering issues such as cognition, memory loss, attention, awareness and orientation to the environment. The participant will be asked for participation at the follow-up meeting after surgery. The interview takes place 2 weeks after follow up-meeting after surgery at the location (or via that media) that best serve the participant. The interview will be recorded and transcribed, then analysed using qualitative content analysis with an inductive and latent approach. |
Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with esophageal or gastric cancer who will be treated with (or without) chemotherapy and surgery at Karolinska University Hospital in Huddinge (Sweden).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marcus Nömm, PhD-student | Contact | 0733765652 | marcus.nomm@ki.se | |
| Maria Lampi, PhD | Contact | 0852483721 | maria.lampi@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Maria Lampi, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital, Huddinge | Recruiting | Huddinge | 14157 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33951145 | Background | Tieges Z, Maclullich AMJ, Anand A, Brookes C, Cassarino M, O'connor M, Ryan D, Saller T, Arora RC, Chang Y, Agarwal K, Taffet G, Quinn T, Shenkin SD, Galvin R. Diagnostic accuracy of the 4AT for delirium detection in older adults: systematic review and meta-analysis. Age Ageing. 2021 May 5;50(3):733-743. doi: 10.1093/ageing/afaa224. | |
| 37260053 |
| Label | URL |
|---|---|
| Cognitive test 4AT | View source |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D000073496 | Frailty |
| D044342 | Malnutrition |
| D055948 | Sarcopenia |
| D000084202 | Chemotherapy-Related Cognitive Impairment |
| D003863 | Depression |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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Frailty is a risk factor for post operative delirium. Frailty will be measured preoperatively with Clinical Frailty Scale (CFS-9).
| At admission for surgery |
| Health-related quality of life | Low score in quality of life is a risk factor for delirium. Patients will report health-related quality of life using the validated European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC-C30) and EORTC validated Quality of Life Questionnaire for Oesophago-Gastric cancer (QLQ-OG25). | From enrollment to the follow up meeting after surgery, approximate 6 months. |
| Malnutrition | Patients with malnutrition before surgery have a higher risk of developing post-operative delirium. Malnutrition is assessed by using Patient-Generated Subjective Global Assessment (PG-SGA) before surgery. | At admission for surgery |
| Sarcopenia | There is association between preoperative sarcopenia and postoperative delirium in patients undergoing gastrointestinal cancer surgery. Sarcopenia is assessed by using CT-scan in clinical routine. | From enrollment to admission for surgery |
| The interview takes place 2 weeks after follow up-meeting |
| Liu J, Li J, Wang J, Zhang M, Han S, Du Y. Associated factors for postoperative delirium following major abdominal surgery: A systematic review and meta-analysis. Int J Geriatr Psychiatry. 2023 Jun;38(6):e5942. doi: 10.1002/gps.5942. |
| 27197918 | Background | Loh KP, Janelsins MC, Mohile SG, Holmes HM, Hsu T, Inouye SK, Karuturi MS, Kimmick GG, Lichtman SM, Magnuson A, Whitehead MI, Wong ML, Ahles TA. Chemotherapy-related cognitive impairment in older patients with cancer. J Geriatr Oncol. 2016 Jul;7(4):270-80. doi: 10.1016/j.jgo.2016.04.008. Epub 2016 Jul 5. |
| 32022748 | Background | Hughes CG, Boncyk CS, Culley DJ, Fleisher LA, Leung JM, McDonagh DL, Gan TJ, McEvoy MD, Miller TE; Perioperative Quality Initiative (POQI) 6 Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Postoperative Delirium Prevention. Anesth Analg. 2020 Jun;130(6):1572-1590. doi: 10.1213/ANE.0000000000004641. |
| European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQC-C30). Quality of life questionnaire for patients with cancer. | View source |
| European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire for Oesophago-Gastric cancer (QLQ-OG25) questionnaire. Quality of life questionnaire for patients with gastroesophageal cancer. | View source |
| Patient Health Questionnaire (PHQ-9), questionnaire about depression | View source |
| Clinical Frailty Scale (CFS-9). Frailty questionnaire | View source |
| Patient-Generated Subjective Global Assessment (PG-SGA). A validated tool for screening and assessing malnutrition | View source |
| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |