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Clinical Trials/NCT05314582
NCT05314582CompletedNot Applicable

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

Bezmialem Vakif University1 site in 1 country500 target enrollmentStarted: March 10, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
500
Locations
1
Primary Endpoint
Episode of clot retention

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Episode of clot retention

Time Frame: 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

Time Frame: Immediately after the surgery up to discharge

Duration of hospitalization

Re-operation rates

Time Frame: Immediately after the surgery up to 1 month

Re-operation requirement for hematuria

Rate of re-admission

Time Frame: From discharge up to one month

Rate of re-admission due to hematuria

Requirement of blood transfusion

Time Frame: Immediately after the surgery up to 1 month

Gross hematuria requiring blood transfusion

Secondary Outcomes

  • Postoperative hematocrit/hemoglobin levels(Immediately after the surgery up to discharge)
  • Amount of irrigation volume(Immediately after the surgery up to discharge)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Abdullah İlktaç

Pincipal investigator

Bezmialem Vakif University

Study Sites (1)

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