Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2026-01-17 @ 2:55 PM
Study NCT ID:
NCT04196166
Status:
COMPLETED
Last Update Posted:
2019-12-12
First Post:
2019-12-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Preoperative Evaluation in Surgical Patient
Sponsor:
Aga Khan University
Organization:
Study Overview
Official Title:
Does More Testing in Routine Preoperative Evaluation Benefit the Surgical Patient? Matched Case Control Study From a Resource-constrained Setting
Status:
COMPLETED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: