NCT04196166

Brief Summary

The "routine" pre-operative tests in healthy orthopaedic patients undergoing intermediate/ major surgery are not justified. In this study of 670 healthy orthopedic patients with 7610 preoperative tests, investigators found that surgical plan was influenced in \<1% of patients. Surgeons should be sensitized to reconsider this practice particularly with limited resources.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Status
completed

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 Start

First participant enrolled

January 1, 2014

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
Last Updated

December 12, 2019

Status Verified

December 1, 2019

Enrollment Period

5.8 years

First QC Date

December 3, 2019

Last Update Submit

December 11, 2019

Conditions

Keywords

preoperative evaluationorthopedic surgery

Outcome Measures

Primary Outcomes (1)

  • preoperative blood tests compliance rate with institutional guidelines

    compliance rate (%) with institutional and international guidelines measured by a questionnaire including whether participant was advised preoperative lab tests in compliance with the institutional guidelines or not.

    2014-2019

Secondary Outcomes (1)

  • Cost difference in local currency

    2014-2019

Study Arms (2)

Cases

nested from on going retrospective cohort study. Participants who had change in their surgical plan after hospitalization.

Other: preoperative blood tests

Controls

nested from on going retrospective cohort study. Participants who didn't have change in their surgical plan after hospitalization.

Other: preoperative blood tests

Interventions

CasesControls

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients irrespective of age and gender who were classified as ASA-1 and ASA-2 by the anesthesia team and who underwent minor, intermediate and major primary elective orthopedic procedures

You may qualify if:

  • Participants irrespective of age and gender.
  • ASA-1 and ASA-2 status.
  • Primary elective orthopedic procedures.
  • Blood lab tests done at the institution only.

You may not qualify if:

  • Ambulatory care procedures
  • Revision surgery.
  • Participants admitted to other services, high care or intensive care units.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 12, 2019

Study Start

January 1, 2014

Primary Completion

October 31, 2019

Study Completion

October 31, 2019

Last Updated

December 12, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Not allowed by organisation