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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Sub-Investigator:
          • Johnson Fam
        • Contact:
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National University of Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 7, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 11, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 6, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 4, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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