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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02822963
Other study ID # A-ER-105-045
Secondary ID
Status Withdrawn
Phase
First received
Last updated
Start date March 2016
Est. completion date August 2016

Study information

Verified date June 2016
Source National Cheng-Kung University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Male
Age group 20 Years and older
Eligibility 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 Design


Locations

Country Name City State
Taiwan National Cheng Kung University Hospital Tainan

Sponsors (1)

Lead Sponsor Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative blood transfusion in 1 week after surgery
Primary Bladder clots in 10 days after surgery
Primary Hematuria in 10 days after surgery
Primary Urine tract infection in 10 days after surgery
Primary Duration of catheter in 10 days after surgery
Primary Duration of hospitalization in 1 week after surgery
Primary Cardiovascular event In 28 days after surgery
Primary Major bleeding In 28 days after surgery
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