NCT Number: NCT04196166
Routine Preoperative Evaluation in Surgical Patient
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.
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Notify MeKey information
Conditions
Age range
1 year–100 year
Sex eligibility
All sexes
Study type
Observational
About this study
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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Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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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
Time frame: 2014-2019
of compliant group Vs non compliant
Sponsors and collaborators
Lead sponsor
Aga Khan University
Other
Registry information
Official study title
Does More Testing in Routine Preoperative Evaluation Benefit the Surgical Patient? Matched Case Control Study From a Resource-constrained Setting
Important dates
- Study start
- 2014
- Primary completion
- 2019
- Study completion
- 2019
- First posted
- Dec 12, 2019
- Registry last updated
- Dec 12, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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