About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with esophageal or gastric cancer, treated with (or without) chemotherapy and surgery.
Age ≥18 at the time for inclusion.
Participate on a voluntary basis and can (for any reason) end its participation during the study.
Capable of giving informed consent.
Disqualifiers
Patients with preoperative cognitive dysfunction such as dementia.
Patients who are inoperable due to metastases.
Patients unable to communicate due to severely impaired hearing and/or - seeing.
Patients with ongoing drug and/or alcohol abuse.
Trial population
Patients diagnosed with esophageal or gastric cancer who will be treated with (or without) chemotherapy and surgery at Karolinska University Hospital in Huddinge (Sweden).
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Preoperative depression
A risk factor for postoperative delirium is preoperative depression. Depression will be measured preoperatively with the Patient Health Questionnaire (PHQ-9).
Preoperative frailty
Frailty is a risk factor for post operative delirium. Frailty will be measured preoperatively with Clinical Frailty Scale (CFS-9).
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).
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.
Other outcomes
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.
Sponsors and contacts
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Karolinska Institutet
Lead sponsor
Region Stockholm
Collaborator