Singapore Perioperative Ageing Study (Sing-PAS)

• ClinicalTrials.gov Identifier: NCT04792554
• Recruitment Status: Recruiting
• First Posted: March 11, 2021
• Last Update Posted: April 19, 2021
• Sponsor: National University Hospital, Singapore
• Collaborator: National University, Singapore
• Information provided by (Responsible Party): National University Hospital, Singapore

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Postoperative Delirium; Aging; Myocardial Injury	Other: Neurocognitive tests and blood taking

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 Design

• Study Type: Observational
• Estimated Enrollment: 600 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Singapore Perioperative Ageing Study (Sing-PAS)
• Actual Study Start Date: April 7, 2021
• Estimated Primary Completion Date: December 2025
• Estimated Study Completion Date: December 2026

Groups and Cohorts

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.	Other: Neurocognitive tests and blood taking; 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.

Outcome Measures

Primary Outcome Measures :

1. 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

Biospecimen Retention:   Samples With DNA

Blood samples

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 100 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

Criteria

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

Contacts and Locations

Contacts

Contact: Lian Kah Ti; 67724200; lian_kah_ti@nuhs.edu.sg

Contact: Lian Kah Ti; lian_kah_ti@nuhs.edu.sg

Locations

Singapore

National University Hospital; Recruiting

Singapore, Singapore, 119074

Contact: Lian Kah Ti 67724200 lian_kah_ti@nuhs.edu.sg

Principal Investigator: Lian Kah Ti

Sub-Investigator: Ne-Hooi Will Loh

Sub-Investigator: Sophia Tsong Huey Chew

Sub-Investigator: Brian Kennedy

Sub-Investigator: Mark Richards

Sub-Investigator: Wei Chieh Alfred Kow

Sub-Investigator: Ning Qi Pang

Sub-Investigator: Johnson Fam

Alexandra Hospital; Active, not recruiting

Singapore, Singapore, 159964

Sponsors and Collaborators

National University Hospital, Singapore

National University, Singapore

Investigators

• Principal Investigator: Lian Kah Ti; National University Health System

More Information

Publications:

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: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.

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. Review. Erratum in: Eur J Anaesthesiol. 2018 Sep;35(9):718-719.

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. Review.

• Responsible Party: National University Hospital, Singapore
• ClinicalTrials.gov Identifier: NCT04792554
• Other Study ID Numbers: 2020/00152
• First Posted: March 11, 2021
• Last Update Posted: April 19, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by National University Hospital, Singapore:

Geriatrics

Additional relevant MeSH terms:

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders