NCT04792554

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
6mo left

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress92%
Apr 2021Dec 2026

First Submitted

Initial submission to the registry

March 8, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2021

Completed
27 days until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

October 6, 2022

Status Verified

September 1, 2022

Enrollment Period

4.7 years

First QC Date

March 8, 2021

Last Update Submit

October 4, 2022

Conditions

Keywords

Geriatrics

Outcome Measures

Primary Outcomes (1)

  • Development of POD in elderly patients undergoing major non-cardiac surgery in a tertiary hospital in Singapore

    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

Study Arms (1)

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

Interventions

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.

Surgical Cohort

Eligibility Criteria

Age65 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National University Hospital

Singapore, 119074, Singapore

RECRUITING

Alexandra Hospital

Singapore, 159964, Singapore

ACTIVE NOT RECRUITING

Related Publications (4)

  • 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.

    PMID: 25926315BACKGROUND
  • 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.

    PMID: 23569671BACKGROUND
  • 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.

    PMID: 28187050BACKGROUND
  • 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.

    PMID: 30336844BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Emergence Delirium

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Neuropsychological TestsPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Lian Kah Ti

    National University Health System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lian Kah Ti

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2021

First Posted

March 11, 2021

Study Start

April 7, 2021

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

October 6, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations