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Clinical Trials/NCT04196166
NCT04196166CompletedNot Applicable

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

Aga Khan University0 sites1,000 target enrollmentStarted: January 1, 2014Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,000
Primary Endpoint
preoperative blood tests compliance rate with institutional guidelines

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
1 Year to 100 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

preoperative blood tests compliance rate with institutional guidelines

Time Frame: 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 Outcomes

  • Cost difference in local currency(2014-2019)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Obada Hasan, FCPS, MRCS, MSc (Epidemiology&Biostatistics)

Principle Investigator

Aga Khan University

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