Study Stopped
It was difficult to proceed with the study according to the protocol, the research was terminated early.
Transthoracic Echocardiographic Evaluation of the Cardiac Function During Transurethral Resection of Prostate in Elderly Patients
1 other identifier
observational
2
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2014
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedMarch 18, 2019
March 1, 2019
5 months
October 30, 2014
March 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
diastolic function by TTE
The participants will be followed for the duration of surgery (TURP), an expected average of 1 hour.
Study Arms (2)
Control
BPH patients with normal diastolic function
Diastolic dysfunction
BPH patients with preoperative diastolic dysfunction
Eligibility Criteria
BPH patients with/without preoperative diastolic dysfunction
You may qualify if:
- Above 65years of age
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- undergoing transurethral resection of the prostate(TURP)"
You may not qualify if:
- 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 "
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2014
First Posted
November 11, 2014
Study Start
December 1, 2014
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
March 18, 2019
Record last verified: 2019-03