Routine Preoperative Evaluation in Surgical Patient

Completed

• Conditions: Orthopedic Disorder
• Interventions: Other: preoperative blood tests

• Registration Number: NCT04196166
• Lead Sponsor: Aga Khan University

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.

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 Timeline

• Study Start: 2014-01-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Status Verified: 2019-12
• Study First Submitted: 2019-12-03
• Study First Submitted QC: 2019-12-11
• Last Update Submitted: 2019-12-11
• Study First Posted: 2019-12-12
• Last Update Posted: 2019-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	preoperative blood tests	nested from on going retrospective cohort study. Participants who had change in their surgical plan after hospitalization.
Controls	preoperative blood tests	nested from on going retrospective cohort study. Participants who didn't have change in their surgical plan after hospitalization.

Primary Outcome Measures

Name	Time	Method
preoperative blood tests compliance rate with institutional guidelines	2014-2019	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.

Secondary Outcome Measures

Name	Time	Method
Cost difference in local currency	2014-2019	of compliant group Vs non compliant