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
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 |
Verified date | July 2023 |
Source | Bezmialem Vakif University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Bezmialem Vakif University | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Bezmialem Vakif University |
Turkey,
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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