Routine Preoperative Evaluation in Surgical Patient

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

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Other: preoperative blood tests

Detailed 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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• Study Type: Observational
• Enrollment (Actual): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cost difference in local currency	of compliant group Vs non compliant	2014-2019

Collaborators and Investigators

• Sponsor: Aga Khan University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): October 31, 2019
• Study Completion (Actual): October 31, 2019

Study Registration Dates

• First Submitted: December 3, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 12, 2019

Study Record Updates

• Last Update Posted (Actual): December 12, 2019
• Last Update Submitted That Met QC Criteria: December 11, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: orthopedic surgery; preoperative evaluation
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: 4226-Sur-ERC-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Not allowed by organisation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No