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

Sponsor

Bezmialem Vakif University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05314582

Collaborator

(none)

240

Enrollment

Location

5.7

Anticipated Duration (Months)

41.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hematuria Retention, Urinary Operative Bleeding Blood Transfusion Complication

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

240 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 10, 2022

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
TURP patients using anticoagulant/antiaggregant medication Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic prostatectomy (TURP).
TURP patients not using anticoagulant/antiaggregant medication Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic prostatectomy (TURP).
TUR-BT patients using anticoagulant/antiaggregant medication Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent endoscopic bladder tumor resection (TUR-BT).
TUR-BT patients not using anticoagulant/antiaggregant medication Patients with no history of anticoagulant/antiaggregant medication and underwent endoscopic bladder tumor resection (TUR-BT).
Open prostatectomy patients using anticoagulant/antiaggregant medication Patients who used anticoagulant/antiaggregant medication for any reason (eg: coronary artery disease, atrial fibrillation, cerebrovascular disease) before surgery and underwent open prostatectomy (OP).
Open prostatectomy patients not using anticoagulant/antiaggregant medication Patients with no history of anticoagulant/antiaggregant medication and underwent open prostatectomy (OP).

Outcome Measures

Primary Outcome Measures

Episode of clot retention [Immediately after the surgery up to 1 month]
Presence of clot retention due to hematuria after the operation which requires manuel irrigation
Requirement of blood transfusion [Immediately after the surgery up to 1 month]
Gross hematuria requiring blood transfusion
Re-operation rates [Immediately after the surgery up to 1 month]
Re-operation requirement for hematuria
Duration of hospitalization [Immediately after the surgery up to discharge]
Duration of hospitalization
Rate of re-admission [From discharge up to one month]
Rate of re-admission due to hematuria

Secondary Outcome Measures

Postoperative hematocrit/hemoglobin levels [Immediately after the surgery up to discharge]
Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.
Amount of irrigation volume [Immediately after the surgery up to discharge]
Amount of postoperative continuous bladder irrigation volume

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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