Skip to main content
. 2018 Jul 18;2018(7):CD012584. doi: 10.1002/14651858.CD012584.pub2

Nielsen 2000.

Methods RCT, single‐centre, parallel study
Participants Total number of randomized participants: 55
Inclusion criteria
  1. 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
  1. Undergoing treatment with anticoagulants, and other NSAIDs

  2. Recent (within 6 months) myocardial infarction

  3. Unstable angina

  4. Stroke

  5. Transient cerebral ischaemia

  6. History of bleeding diathesis

  7. Serum creatinine > 200 mmol/L

  8. Arterial hypertension with blood pressure > 220/120 mmHg


Type of surgery
  1. TURP


Baseline characteristics
Continuation group
  1. Age, median (IQR): 70 (66 to 74) years

  2. Gender: all male participants

  3. BMI, mean (SD): not reported

  4. Severity of illness: not reported

  5. Type of anaesthesia, n: SPA: all participants

  6. Participants with coronary stent, n: not reported

  7. Reason for having antiplatelet therapy: not reported

  8. Type of antiplatelet therapy prior to study: 150 mg to 300 mg aspirin

  9. Duration of antiplatelet therapy prior to study: not reported


Discontinuation group
  1. Age, median (IQR): 69 (65 to 76) years

  2. Gender: all male participants

  3. BMI, mean (SD): not reported

  4. Severity of illness score: not reported

  5. Type of anaesthesia, n: SPA: all participants

  6. Participants with coronary stent, n: not reported

  7. Reason for having antiplatelet therapy: not reported

  8. Type of antiplatelet therapy prior to study: 150 to 300 mg aspirin

  9. Duration of antiplatelet therapy prior to study: not reported


Country: Denmark
Setting: hospital
Interventions Continuation group
  1. Number of analysed participants = 26 (study authors report 2 losses after randomization but do not report total number of randomized participants in each group)

  2. 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
  1. Number of analysed participants = 27 (study authors report 2 losses after randomization but do not report total number of randomized participants in each group)

  2. Details: usual antiplatelet therapy discontinued 10 days prior to study and participant given placebo. Participants resumed usual antiplatelet therapy after catheter removal

Outcomes
  1. Intra‐operative and postoperative blood loss

  2. Transfusion requirements

  3. Re‐operation due to blood loss

  4. Myocardial infarction

  5. Mortality

  6. Secondary haemorrhage

  7. Length of hospital stay

  8. Median time to catheter removal

  9. 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