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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04196166
Other study ID # 4226-Sur-ERC-16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date October 31, 2019

Study information

Verified date December 2019
Source Aga Khan University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Background: Routine preoperative tests in healthy patients not only cause extra anxiety, but may delay treatment without influencing surgical plan. This has worse impact in resource-constrained settings where fee for service rather than health insurance is the usual norm. Investigators aim to determine if "routine" pre-operative tests are justified in healthy orthopedic patients.

Methods: Investigators conducted a non-commercialized, non-funded matched case control study in tertiary care university hospital and a level-1 trauma centre for healthy patients (ASA-1&2) admitted from January 2014-December 2016 for elective orthopedic intermediate and major procedures. Cases (patient who had a change in his/her surgical plan after admission) and controls were selected independently of the exposure of interest then matched randomly to cases on age, gender and procedure type. Primary exposure was the routine preoperative lab tests, as defined by the American Society of Anesthesiologist, which included 13 blood tests. Analysis was done using Principle Component Analysis and Conditional logistic regression at univariate and multivariable levels reporting matched adjusted Odds Ratios. The data will bereported in line with STROBE criteria.

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Recruitment information / eligibility

Status Completed
Enrollment 1000
Est. completion date October 31, 2019
Est. primary completion date October 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 100 Years
Eligibility Inclusion Criteria:

- Participants irrespective of age and gender.

- ASA-1 and ASA-2 status.

- Primary elective orthopedic procedures.

- Blood lab tests done at the institution only.

Exclusion Criteria:

- Ambulatory care procedures

- Revision surgery.

- Participants admitted to other services, high care or intensive care units.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
preoperative blood tests


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Aga Khan University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cost difference in local currency of compliant group Vs non compliant 2014-2019
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