Routine Preoperative Evaluation in Surgical Patient

NCT ID: NCT04196166

Last Updated: 2019-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2019-10-31

Brief Summary

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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

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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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Conditions

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Orthopedic Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cases

nested from on going retrospective cohort study. Participants who had change in their surgical plan after hospitalization.

preoperative blood tests

Intervention Type OTHER

Controls

nested from on going retrospective cohort study. Participants who didn't have change in their surgical plan after hospitalization.

preoperative blood tests

Intervention Type OTHER

Interventions

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preoperative blood tests

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aga Khan University

OTHER

Sponsor Role lead

Responsible Party

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

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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4226-Sur-ERC-16

Identifier Type: -

Identifier Source: org_study_id

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