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

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ClinicalTrials.gov Identifier: NCT02822963
Recruitment Status : Recruiting
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
National Cheng-Kung University Hospital

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
Benign Prostatic Hyperplasia Prostate Cancer

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : March 2016
Estimated Primary Completion Date : July 2016
Estimated Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.



Primary Outcome Measures :
  1. Perioperative blood transfusion [ Time Frame: in 1 week after surgery ]
  2. Bladder clots [ Time Frame: in 10 days after surgery ]
  3. Hematuria [ Time Frame: in 10 days after surgery ]
  4. Urine tract infection [ Time Frame: in 10 days after surgery ]
  5. Duration of catheter [ Time Frame: in 10 days after surgery ]
  6. Duration of hospitalization [ Time Frame: in 1 week after surgery ]
  7. Cardiovascular event [ Time Frame: In 28 days after surgery ]
  8. Major bleeding [ Time Frame: In 28 days after surgery ]


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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male admitted to National Cheng Kung University Hospital for TURP.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02822963


Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan
Contact: Yi-Cheng Luo    886-6-2343434 ext 5693    b99403039@gmail.com   
Sponsors and Collaborators
National Cheng-Kung University Hospital

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02822963     History of Changes
Other Study ID Numbers: A-ER-105-045
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: June 2016

Keywords provided by National Cheng-Kung University Hospital:
Transurethral resection of the prostate
Anticoagulants
Platelet aggregation inhibitors

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Anticoagulants
Platelet Aggregation Inhibitors