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

July 27, 2023 updated by: Abdullah İlktaç, Bezmialem Vakif University

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34093
        • Bezmialem Vakif University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Episode of clot retention
Time Frame: Immediately after the surgery up to 1 month
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
Time Frame: Immediately after the surgery up to 1 month
Gross hematuria requiring blood transfusion
Immediately after the surgery up to 1 month
Re-operation rates
Time Frame: Immediately after the surgery up to 1 month
Re-operation requirement for hematuria
Immediately after the surgery up to 1 month
Duration of hospitalization
Time Frame: Immediately after the surgery up to discharge
Duration of hospitalization
Immediately after the surgery up to discharge
Rate of re-admission
Time Frame: From discharge up to one month
Rate of re-admission due to hematuria
From discharge up to one month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative hematocrit/hemoglobin levels
Time Frame: Immediately after the surgery up to discharge
Change in the Postoperative hematocrit/hemoglobin levels compared to the preoperative values.
Immediately after the surgery up to discharge
Amount of irrigation volume
Time Frame: Immediately after the surgery up to discharge
Amount of postoperative continuous bladder irrigation volume
Immediately after the surgery up to discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bezmialem Vakif University

Investigators

  • Study Chair: Abdullah Ilktac, MD, Bezmialem Vakif University, Faculty of Medicine, Department of Urology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2022

Primary Completion (Actual)

December 10, 2022

Study Completion (Actual)

January 10, 2023

Study Registration Dates

First Submitted

March 27, 2022

First Submitted That Met QC Criteria

April 5, 2022

First Posted (Actual)

April 6, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 196083

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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