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:

  1. Above 65years of age
  2. American Society of Anesthesiologists (ASA) Physical Status I, II, III.
  3. undergoing transurethral resection of the prostate(TURP)"

Exclusion Criteria:

  1. severe coagulopathy or bleeding disorder(platelet count<75000, PT INR >1.2)
  2. short stature (under 150 cm)
  3. underwent coronary artery bypass graft
  4. 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.

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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