Methods |
RCT, single‐centre, parallel study |
Participants |
Total number of randomized participants: 55 Inclusion criteria
Male patients on low‐dose acetylsalicylic acid therapy (150 mg to 300 mg) with obstructive symptoms, and clinical and laboratory evidence suggestive of benign or malignant prostatic enlargement
Exclusion criteria
Undergoing treatment with anticoagulants, and other NSAIDs
Recent (within 6 months) myocardial infarction
Unstable angina
Stroke
Transient cerebral ischaemia
History of bleeding diathesis
Serum creatinine > 200 mmol/L
Arterial hypertension with blood pressure > 220/120 mmHg
Type of surgery
TURP
Baseline characteristics Continuation group
Age, median (IQR): 70 (66 to 74) years
Gender: all male participants
BMI, mean (SD): not reported
Severity of illness: not reported
Type of anaesthesia, n: SPA: all participants
Participants with coronary stent, n: not reported
Reason for having antiplatelet therapy: not reported
Type of antiplatelet therapy prior to study: 150 mg to 300 mg aspirin
Duration of antiplatelet therapy prior to study: not reported
Discontinuation group
Age, median (IQR): 69 (65 to 76) years
Gender: all male participants
BMI, mean (SD): not reported
Severity of illness score: not reported
Type of anaesthesia, n: SPA: all participants
Participants with coronary stent, n: not reported
Reason for having antiplatelet therapy: not reported
Type of antiplatelet therapy prior to study: 150 to 300 mg aspirin
Duration of antiplatelet therapy prior to study: not reported
Country: Denmark Setting: hospital |
Interventions |
Continuation group
Number of analysed participants = 26 (study authors report 2 losses after randomization but do not report total number of randomized participants in each group)
Details: usual dose of aspirin was discontinued 10 days before surgery and participant given 150 mg aspirin. Participants resumed usual dose after catheter removal
Discontinuation group
Number of analysed participants = 27 (study authors report 2 losses after randomization but do not report total number of randomized participants in each group)
Details: usual antiplatelet therapy discontinued 10 days prior to study and participant given placebo. Participants resumed usual antiplatelet therapy after catheter removal
|
Outcomes |
Intra‐operative and postoperative blood loss
Transfusion requirements
Re‐operation due to blood loss
Myocardial infarction
Mortality
Secondary haemorrhage
Length of hospital stay
Median time to catheter removal
Histology
|
Notes |
Funding/declarations of interest: Leo Pharmaceutical Products, Ballerup, Denmark. Donated medication Study dates: not reported |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Stated as randomized but no additional details describing random sequence generation were provided in the published study report |
Allocation concealment (selection bias) |
Unclear risk |
Allocation list was kept at the pharmaceutical company which provided the drugs. No additional details |
Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Stated as double‐blind and placebo was used to blind the participants. We assumed that personnel were also blinded to group allocation |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
No details describing blinding of outcome assessment were provided in the published study report |
Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Two losses from each group. Study authors do not report to which group these participants belonged. However, few losses and unlikely to influence outcome data |
Selective reporting (reporting bias) |
Unclear risk |
Clinical trial registration or prospectively published protocol not reported. Not feasible to assess risk of selective reporting bias |
Other bias |
Unclear risk |
Study is supported by pharmaceutical company. Study authors do not report level of involvement in trial design and management by the company. Baseline characteristics not reported |