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

Hematuria Clinical Trial

Official title:

Investigation of the Effects of Anticoagulant/Antiaggregant Use on Postoperative Bleeding Risk in Patients Operated for Bladder Tumor and Benign Prostatic Hyperplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05314582
• Other study ID #: 196083
• Status: Completed
• Start date: March 10, 2022
• Est. completion date: January 10, 2023

Study information

• Verified date: July 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 10, 2023
• Est. primary completion date: December 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Transfusion Complication
• Hematuria
• Hemorrhage
• Hyperplasia
• Operative Bleeding
• Postoperative Hemorrhage
• Prostatic Hyperplasia
• Retention, Urinary
• Transfusion Reaction
• Urinary Bladder Neoplasms
• Urinary Retention

Locations

Country	Name	City	State
Turkey	Bezmialem Vakif University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Episode of clot retention	Presence of clot retention due to hematuria after the operation which requires manuel irrigation	Immediately after the surgery up to 1 month
Primary	Requirement of blood transfusion	Gross hematuria requiring blood transfusion	Immediately after the surgery up to 1 month
Primary	Re-operation rates	Re-operation requirement for hematuria	Immediately after the surgery up to 1 month
Primary	Duration of hospitalization	Duration of hospitalization	Immediately after the surgery up to discharge
Primary	Rate of re-admission	Rate of re-admission due to hematuria	From discharge up to one month
Secondary	Postoperative hematocrit/hemoglobin levels	Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.	Immediately after the surgery up to discharge
Secondary	Amount of irrigation volume	Amount of postoperative continuous bladder irrigation volume	Immediately after the surgery up to discharge