- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04792554
Singapore Perioperative Ageing Study (Sing-PAS)
October 4, 2022 updated by: National University Hospital, Singapore
The specific aim of the study will be to set up a perioperative database to longitudinally track the progress of elderly patients undergoing major surgery from the preoperative period to five years postoperatively.
This database will form the foundation of a programme that will be sustainable through future grants to implement clinical strategies to improve outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Singaporeans are rapidly ageing.
One in every 4 Singaporeans will be aged 65 years and older in 2030, double the rate of that in 2015.
Elderly patients have more chronic diseases and have a poorer recovery profile after illness or surgery.
More recently, it has been reported that Singaporeans spend 10 years of their lives in poor health.
Elderly patients are over-represented in patients coming for surgery, particularly for major cardiac and non-cardiac surgeries.
While surgery is wonderful and lifesaving, the truth is that many elderly patients do not do well after major surgery.
This was eloquently reported in the New York Times recently in an article titled "The Elderly Are Getting Complex Surgeries.
Often It Doesn't End Well."
Elderly patients value quality of life over quantity of life, but many are not aware of the long-term debilitation, organ dysfunction, pain, depression, economic burden and social strain that frequently accompanies major surgery.
Elderly patients are more likely to lose independence after surgery, both physically and cognitively, and may never recover fully.
There is clearly a disconnect between the elderly patient's (and their loved ones') expectations and reality.
There is therefore a need to look closely at the operative journey of the elderly patient undergoing major surgery.
Currently, clinical care is primarily concerned about achieving a technically successful surgery and recovery in the immediate postoperative phase, but there is much less oversight once the patient leaves the hospital system to community care.
However, perioperative management significantly impacts the quality of life and activities of daily living for years after surgery.
At NUHS, the MILES (Management and Innovation for Longevity in Elderly Surgical patients) programme has successfully reduced hospital length of stay of elderly patients undergoing abdominal surgery by addressing frailty and performing prehabilitation in selected patients.
In this study, the study team intend to expand on this clinical programme to look at 3 primary concerns, namely postoperative delirium, trajectory of ageing, and myocardial injury, and the long-term implications of these concerns.
Second, the team will incorporate biomarkers and other investigations to better risk profile patients, elucidate mechanistic processes, and provide better diagnostic and prognostic tools to clinicians.
Third, the team will investigate the complimentary and detrimental roles of common systemic pathologies such as diabetes, anemia, renal dysfunction, malignancy, pain, and poor sleep on these outcomes.
Therefore, the team intends to do a longitudinal study starting from the preoperative period up to 5 years after surgery in patients aged 65 years and above undergoing elective non-cardiac major surgery, defined as a surgery lasting at least 2 hours and requiring at least one day stay in hospital after surgery.
It is envisioned that by using the data gained from this study, the investigators will be able to identify risk factors, trajectories of outcomes and gaps in their clinical care, and from there, formulate clinical strategies to address these gaps and mitigate the risk factors.
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lian Kah Ti
- Phone Number: 67724200
- Email: lian_kah_ti@nuhs.edu.sg
Study Contact Backup
- Name: Lian Kah Ti
- Email: lian_kah_ti@nuhs.edu.sg
Study Locations
-
-
-
Singapore, Singapore, 119074
- Recruiting
- National University Hospital
-
Sub-Investigator:
- Johnson Fam
-
Contact:
- Lian Kah Ti
- Phone Number: 67724200
- Email: lian_kah_ti@nuhs.edu.sg
-
Principal Investigator:
- Lian Kah Ti
-
Sub-Investigator:
- Ne-Hooi Will Loh
-
Sub-Investigator:
- Brian Kennedy
-
Sub-Investigator:
- Mark Richards
-
Sub-Investigator:
- Wei Chieh Alfred Kow
-
Sub-Investigator:
- Ning Qi Pang
-
Singapore, Singapore, 159964
- Active, not recruiting
- Alexandra Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years to 100 years (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Elderly patients aged 65 and above who are planned for major non-cardiac surgery predicted to be at least 2 hours in duration and requiring at least 1 postoperative stay in hospital.
Description
Inclusion Criteria:
- Elderly patients aged 65 years and above
- Undergoing major non-cardiac surgery, defined as surgery that is predicted to be at least 2 hours and requiring at least 1 day postoperative stay in the hospital
- English, Chinese or Malay speaking
- Ability to provide informed consent
Exclusion Criteria:
- History of psychiatric disease
- Illiterate
- An active history of substance abuse.
- Undergoing neurological procedures
- Undergoing emergency surgeries
- Has a second surgery planned within 5 days of index surgery
- Non-resident of Singapore
- Severe hearing and/or speech impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Surgical Cohort
Elderly patients aged 65 and above who are planned for major non-cardiac surgery predicted to be at least 2 hours in duration and requiring at least 1 postoperative stay in hospital.
|
Battery of neurocognitive tests and questionnaires including MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, Global Physical Activity Questionnaire, Brief Pain Index, Brief Psychiatric Rating Scale, NuDESC, 3D-CAM.
Blood taking.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Development of POD in elderly patients undergoing major non-cardiac surgery in a tertiary hospital in Singapore
Time Frame: Before surgery through to 5 years post surgery
|
Collection of patient's demographics, medical records and surgical records to establish risk factors for POD development
|
Before surgery through to 5 years post surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lian Kah Ti, National University Health System
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Evered L, Silbert B, Knopman DS, Scott DA, DeKosky ST, Rasmussen LS, Oh ES, Crosby G, Berger M, Eckenhoff RG; Nomenclature Consensus Working Group. Recommendations for the nomenclature of cognitive change associated with anaesthesia and surgery-2018. Br J Anaesth. 2018 Nov;121(5):1005-1012. doi: 10.1016/j.bja.2017.11.087. Epub 2018 Jun 15.
- Aldecoa C, Bettelli G, Bilotta F, Sanders RD, Audisio R, Borozdina A, Cherubini A, Jones C, Kehlet H, MacLullich A, Radtke F, Riese F, Slooter AJ, Veyckemans F, Kramer S, Neuner B, Weiss B, Spies CD. European Society of Anaesthesiology evidence-based and consensus-based guideline on postoperative delirium. Eur J Anaesthesiol. 2017 Apr;34(4):192-214. doi: 10.1097/EJA.0000000000000594. Erratum In: Eur J Anaesthesiol. 2018 Sep;35(9):718-719.
- Rose J, Weiser TG, Hider P, Wilson L, Gruen RL, Bickler SW. Estimated need for surgery worldwide based on prevalence of diseases: a modelling strategy for the WHO Global Health Estimate. Lancet Glob Health. 2015 Apr 27;3 Suppl 2(Suppl 2):S13-20. doi: 10.1016/S2214-109X(15)70087-2.
- Yang R, Wolfson M, Lewis MC. Unique Aspects of the Elderly Surgical Population: An Anesthesiologist's Perspective. Geriatr Orthop Surg Rehabil. 2011 Mar;2(2):56-64. doi: 10.1177/2151458510394606.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 7, 2021
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
March 8, 2021
First Submitted That Met QC Criteria
March 8, 2021
First Posted (Actual)
March 11, 2021
Study Record Updates
Last Update Posted (Actual)
October 6, 2022
Last Update Submitted That Met QC Criteria
October 4, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/00152
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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