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

NCT02822963 | Withdrawn

• 1 other identifier: A-ER-105-045
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Prostatic Hyperplasia; Prostate Cancer

Keywords

Transurethral resection of the prostate; Anticoagulants; Platelet aggregation inhibitors

Outcome Measures

Primary Outcomes (8)

• Perioperative blood transfusion

  in 1 week after surgery

• Bladder clots

  in 10 days after surgery

• Hematuria

  in 10 days after surgery

• Urine tract infection

  in 10 days after surgery

• Duration of catheter

  in 10 days after surgery

• Duration of hospitalization

  in 1 week after surgery

• Cardiovascular event

  In 28 days after surgery

• Major bleeding

  In 28 days after surgery

Study Arms (3)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male admitted to National Cheng Kung University Hospital for TURP.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, Taiwan

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2016
• First Posted: July 6, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 6, 2020

Record last verified: 2016-06

Locations

TW (1)