Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia

Completed

• Conditions: Retention, Urinary; Operative Bleeding; Hematuria; Blood Transfusion Complication

• Registration Number: NCT05314582
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

Patients who were using anticoagulant or antiaggregant medications for any reason and underwent transurethral resection of bladder tumor (TUR-BT) or transurethral resection of the prostate (TURP) or open prostatectomy (OP) due to BPH will be compared with those who were not using anticoagulant or antiplatelet medication. The rates of postoperative clot retention, presence of hematuria, reoperation due to hematuria, blood transfusion and re-admissions due to hematuria in the first postoperative month will be compared.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Study First Submitted: 2022-03-27
• Study First Submitted QC: 2022-04-05
• Study First Posted: 2022-04-06
• Primary Completion: 2022-12-10
• Study Completion: 2023-01-10
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-27
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients undergoing complete endoscopic transurethral tumor resection (TUR-BT) for bladder cancer
• Patients undergoing TURP due to benign prostatic hyperplasia
• Patients undergoing open prostatectomy due to benign prostatic hyperplasia

Exclusion Criteria

• Patients who underwent incomplete transurethral tumor resection for bladder cancer
• Patient who underwent TUR biopsy for restaging with no obvious macroscopic tumoral lesion
• Patients who underwent cystectomy for bladder cancer

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Episode of clot retention	Immediately after the surgery up to 1 month	Presence of clot retention due to hematuria after the operation which requires manuel irrigation
Duration of hospitalization	Immediately after the surgery up to discharge	Duration of hospitalization
Re-operation rates	Immediately after the surgery up to 1 month	Re-operation requirement for hematuria
Rate of re-admission	From discharge up to one month	Rate of re-admission due to hematuria
Requirement of blood transfusion	Immediately after the surgery up to 1 month	Gross hematuria requiring blood transfusion

Secondary Outcome Measures

Name	Time	Method
Postoperative hematocrit/hemoglobin levels	Immediately after the surgery up to discharge	Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.
Amount of irrigation volume	Immediately after the surgery up to discharge	Amount of postoperative continuous bladder irrigation volume

Trial Locations

Locations (1)

Bezmialem Vakif University; 🇹🇷 Istanbul, Turkey