Clinical trial NCT05314582: Anticoagulant/Antiaggregant Use and Postoperative Bleeding Risk in Patients With Bladder Tumor and Benign Prostatic Hyperplasia
Official title: Investigation of the Effects of Anticoagulant/Antiaggregant Use on Postoperative Bleeding Risk in Patients Operated for Bladder Tumor and Benign Prostatic Hyperplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematuria
Retention, Urinary
Operative Bleeding
Blood Transfusion Complication
Keywords: bladder cancer
benign prostatic hyperplasia
transurethral resection
hematuria
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were referred to endoscopic bladder tumor resection (TUR-BT) or open or endoscopic BPH surgery (TURP or open prostatectomy) will be included in this study. For patients using anticoagulant/antiaggregant medications, relevant specialty (eg: Cardiology, neurology, cardiovascular surgery) or anesthesiologist will decide whether the patient will quit these medications before surgery or not, when to quit and whether low molecular weight heparin will be started instead. The responsible physician of the patient will decide when to restart the anticoagulant therapy after the surgery.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Episode of clot retention
timeFrame: Immediately after the surgery up to 1 month
measure: Requirement of blood transfusion
timeFrame: Immediately after the surgery up to 1 month
measure: Re-operation rates
timeFrame: Immediately after the surgery up to 1 month
measure: Duration of hospitalization
timeFrame: Immediately after the surgery up to discharge
measure: Rate of re-admission
timeFrame: From discharge up to one month
Secondary outcomes:
measure: Postoperative hematocrit/hemoglobin levels
timeFrame: Immediately after the surgery up to discharge
measure: Amount of irrigation volume
timeFrame: Immediately after the surgery up to discharge
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
Study officials:
affiliation: Bezmialem Vakif University, Faculty of Medicine, Department of Urology
name: Abdullah Ilktac, MD
role: STUDY_CHAIR
References: