NCT02288780

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

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2014

Shorter than P25 for all trials

Status
terminated

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

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 11, 2014

Completed
20 days until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

October 30, 2014

Last Update Submit

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

Age65 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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