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

Sponsor
National Cheng-Kung University Hospital (Other)
Overall Status
Withdrawn
CT.gov ID
NCT02822963
Collaborator
(none)
0
Enrollment
1
Location
5
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Mar 1, 2016
    Anticipated Primary Completion Date :
    Jul 1, 2016
    Anticipated Study Completion Date :
    Aug 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Perioperative blood transfusion [in 1 week after surgery]

    2. Bladder clots [in 10 days after surgery]

    3. Hematuria [in 10 days after surgery]

    4. Urine tract infection [in 10 days after surgery]

    5. Duration of catheter [in 10 days after surgery]

    6. Duration of hospitalization [in 1 week after surgery]

    7. Cardiovascular event [In 28 days after surgery]

    8. Major bleeding [In 28 days after surgery]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Cheng Kung University Hospital Tainan Taiwan

    Sponsors and Collaborators

    • National Cheng-Kung University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Cheng-Kung University Hospital
    ClinicalTrials.gov Identifier:
    NCT02822963
    Other Study ID Numbers:
    • A-ER-105-045
    First Posted:
    Jul 6, 2016
    Last Update Posted:
    Oct 6, 2020
    Last Verified:
    Jun 1, 2016
    Keywords provided by National Cheng-Kung University Hospital
    Transurethral resection of the prostate
    Anticoagulants
    Platelet aggregation inhibitors
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia

    Study Results

    No Results Posted as of Oct 6, 2020