Routine Preoperative Evaluation in Surgical Patient

Orthopedic Disorder Clinical Trial

Official title:

Does More Testing in Routine Preoperative Evaluation Benefit the Surgical Patient? Matched Case Control Study From a Resource-constrained Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04196166
• Other study ID #: 4226-Sur-ERC-16
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

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