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

NCT05314582 | Completed

• 1 other identifier: 196083
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematuria; Retention, Urinary; Operative Bleeding; Blood Transfusion Complication

Keywords

bladder cancer; benign prostatic hyperplasia; transurethral resection; hematuria

Outcome Measures

Primary Outcomes (5)

• 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

• Requirement of blood transfusion

  Gross hematuria requiring blood transfusion

  Immediately after the surgery up to 1 month

• Re-operation rates

  Re-operation requirement for hematuria

  Immediately after the surgery up to 1 month

• Duration of hospitalization

  Duration of hospitalization

  Immediately after the surgery up to discharge

• Rate of re-admission

  Rate of re-admission due to hematuria

  From discharge up to one month

Secondary Outcomes (2)

• Postoperative hematocrit/hemoglobin levels

  Immediately after the surgery up to discharge

• Amount of irrigation volume

  Immediately after the surgery up to discharge

Study Arms (6)

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).

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bezmialem Vakif University: lead

Study Sites (1)

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hematuria; Urinary Retention; Transfusion Reaction; Urinary Bladder Neoplasms; Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases; Immune System Diseases; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases

Study Officials

• Abdullah Ilktac, MD

  Bezmialem Vakif University, Faculty of Medicine, Department of Urology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pincipal investigator

Study Record Dates

• First Submitted: March 27, 2022
• First Posted: April 6, 2022
• Study Start: March 10, 2022
• Primary Completion: December 10, 2022
• Study Completion: January 10, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Locations

TU (1)