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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05314582
Other study ID # 196083
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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