Impact of Anticoagulants and Antiplatelets in Patients on Transurethral Resection of the Prostate

October 4, 2020 updated by: National Cheng-Kung University Hospital
Benign prostatic hyperplasia(BPH) is a common disease in urology among old men. If BPH symptom cannot be controlled by drugs, then transurethral resection of the prostate (TURP), is recommended. Although the procedure is quit safe, these old men often take anticoagulants and antiplatelets to control cardiovascular diseases, which arose some concerns for their bleeding risk. The management of anticoagulation in patients undergoing surgical procedures is challenging because interrupting anticoagulation increases the risk of thrombotic events. At the same time, surgery and invasive procedures have associated bleeding risks that are increased by the anticoagulant administration. Now, the recommendation about anticoagulants and antiplatelets discontinuation had no concrete evidence, especially in TURP. Furthermore, there is no relative studies done in Taiwan population, which calls for further investigation.

Study Overview

Status

Withdrawn

Conditions

Study Type

Observational

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

  • Taiwan
      • Tainan, Taiwan
        • National Cheng Kung University Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Male admitted to National Cheng Kung University Hospital for TURP.

Description

Inclusion Criteria:

  • Admitted to National Cheng Kung University Hospital Urology during the study
  • Older than 20 years old
  • Agree to participate this study
  • Receiving transurethral resection of the prostate for benign prostatic hyperplasia or prostate cancer

Exclusion Criteria:

  • Poor expression ability and without close care givers to answer questions

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
A
Non anticoagulant and/or antiplatelet users.
B
Anticoagulant and/or antiplatelet users that hold their drugs during perioperative periods.
C
Anticoagulant and/or antiplatelet users that doesn't hold their drugs during perioperative periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Perioperative blood transfusion
Time Frame: in 1 week after surgery
in 1 week after surgery
Bladder clots
Time Frame: in 10 days after surgery
in 10 days after surgery
Hematuria
Time Frame: in 10 days after surgery
in 10 days after surgery
Urine tract infection
Time Frame: in 10 days after surgery
in 10 days after surgery
Duration of catheter
Time Frame: in 10 days after surgery
in 10 days after surgery
Duration of hospitalization
Time Frame: in 1 week after surgery
in 1 week after surgery
Cardiovascular event
Time Frame: In 28 days after surgery
In 28 days after surgery
Major bleeding
Time Frame: In 28 days after surgery
In 28 days after surgery

Collaborators and Investigators

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

Sponsor

National Cheng-Kung University Hospital

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

March 1, 2016

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimate)

July 6, 2016

Study Record Updates

Last Update Posted (Actual)

October 6, 2020

Last Update Submitted That Met QC Criteria

October 4, 2020

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A-ER-105-045

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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