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Definition, analysis, reporting, and interpretation of perioperative bleeding in randomized controlled trials: a
Yasaman Mohammadi Kamalabadi1, Guangyong Zou2,3,4, Maha El-Shimy2
1Department of Epidemiology and Biostatistics, Schulich School of Medicine and Dentistry, Western University, London, Canada. ymoham24@uwo.ca.
Perioperative Medicine (London, England)
|July 2, 2026
Summary
Perioperative bleeding definitions and analyses in randomized trials lack consistency, impacting trial design and interpretation. Standardized methods are crucial for improving comparability and clinical relevance in surgical research.
Area of Science:
- Surgical Research
- Clinical Trials
- Evidence-Based Medicine
Background:
- Perioperative bleeding is a common surgical complication and a key outcome in randomized trials.
- Inconsistent definitions and analyses of perioperative bleeding complicate trial design, statistical power, and interpretation of treatment effects.
Purpose of the Study:
- To systematically review definitions, sample size considerations, analytic approaches, and interpretation practices for perioperative bleeding outcomes in randomized controlled trials (RCTs).
Main Methods:
- Systematic search of the CENTRAL database for RCTs published after January 2024 evaluating perioperative bleeding as a primary outcome.
- Independent screening and data extraction by two reviewers.
- Descriptive analysis of categorized findings.
Main Results:
- 115 trials reported 116 bleeding outcomes with 36 unique definitions and varied assessment periods (intraoperative to >30 days postoperatively).
- Volumetric/gravimetric measures were most common (39.6%); patient-reported events (4.3%) and clinical management (3.4%) were rare.
- Most trials reported sample size calculations (78.3%), but over a third lacked effect-size justification (37.8%). Analyses were predominantly parametric (59.5%), and interpretation often relied on statistical significance (47.6%) in superiority trials, with noninferiority trials frequently lacking prespecified margins.
Conclusions:
- Significant inconsistency exists in defining and analyzing perioperative bleeding outcomes across RCTs.
- Standardized outcome definitions and reporting practices are essential to enhance the comparability and clinical relevance of surgical trials.
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