- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02288780
Transthoracic Echocardiographic Evaluation of the Cardiac Function During Transurethral Resection of Prostate in Elderly Patients
March 14, 2019 updated by: Yonsei University
Transurethral resection of the prostate (TURP) is a standard surgical treatment for benign prostatic hyperplasia (BPH).
Non-conductive irrigation fluid is used to maintain good visibility of the operating field during resection of the prostate.
Absorption of this hypotonic solution into the bloodstream can cause fluid overload and dilutional hyponatremia, resulting in adverse cardiovascular and central nervous system effects, transurethral resection (TUR) syndrome.
BPH is common in elderly men above 60 years old.
These aged people commonly have diastolic impairment by normal physiologic change without consistent symptom.
This study aimed to evaluate the cardiac function focused mainly diastolic function during TURP with transthoracic echocardiography.
Also, we will focus the effets of amount of irrgation fluid on left ventricular diastolic function in patients with pre-existing diastolic dysfunction.
Study Overview
Status
Terminated
Conditions
Study Type
Observational
Enrollment (Actual)
2
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
65 years to 85 years (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
BPH patients with/without preoperative diastolic dysfunction
Description
Inclusion Criteria:
- Above 65years of age
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- undergoing transurethral resection of the prostate(TURP)"
Exclusion Criteria:
- severe coagulopathy or bleeding disorder(platelet count<75000, PT INR >1.2)
- short stature (under 150 cm)
- underwent coronary artery bypass graft
- contraindications of regional anesthesia "
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
Cohorts and Interventions
Group / Cohort |
---|
Control
BPH patients with normal diastolic function
|
Diastolic dysfunction
BPH patients with preoperative diastolic dysfunction
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
diastolic function by TTE
Time Frame: The participants will be followed for the duration of surgery (TURP), an expected average of 1 hour.
|
The participants will be followed for the duration of surgery (TURP), an expected average of 1 hour.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (ACTUAL)
December 1, 2014
Primary Completion (ACTUAL)
May 1, 2015
Study Completion (ACTUAL)
May 1, 2015
Study Registration Dates
First Submitted
October 30, 2014
First Submitted That Met QC Criteria
November 10, 2014
First Posted (ESTIMATE)
November 11, 2014
Study Record Updates
Last Update Posted (ACTUAL)
March 18, 2019
Last Update Submitted That Met QC Criteria
March 14, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Other Study ID Numbers
- 4-2014-0734
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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