BPHNCT02288780
Transthoracic Echocardiographic Evaluation of the Cardiac Function During Transurethral Resection of Prostate in Elderly Patients
An observational study of BPH, run by Yonsei University.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 85 years, men only
- Conditions the study is for
- BPH
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to 1 May 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- Men only
- No healthy volunteers
- Older adult
Study population: BPH patients with/without preoperative diastolic dysfunction
Who may be able to join
- Above 65years of age
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- undergoing transurethral resection of the prostate(TURP)"
Who cannot join
- 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 "
About this study
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.
- Conditions
- BPH
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | BPH patients with normal diastolic function | |
| Diastolic dysfunction | BPH patients with preoperative diastolic dysfunction |
What is being measured
The primary outcome is the main question the study is designed to answer.
diastolic function by TTE
Measured: The participants will be followed for the duration of surgery (TURP), an expected average of 1 hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion1 May 2015
- Study completion1 May 2015
Why it stopped: It was difficult to proceed with the study according to the protocol, the research was terminated early.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288780
- Sponsor's protocol ID
- 4-2014-0734
- Status last verified
- Mar 2019
- First submitted
- 30 Oct 2014
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Echocardiographic Evaluation of the Cardiac Function During Transurethral Resection of Prostate in Elderly Patients
- ClinicalTrials.gov ID
- NCT02288780
- Acronym / sponsor ID
- 4-2014-0734
- Conditions
- BPH
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: It was difficult to proceed with the study according to the protocol, the research was terminated early.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 1 May 2015 (actual)
- Study completion
- 1 May 2015 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –BPH patients with normal diastolic function |
| Diastolic dysfunction | – | –BPH patients with preoperative diastolic dysfunction |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- BPH patients with/without preoperative diastolic dysfunction
Key inclusion criteria (3 listed)
- Above 65years of age
- American Society of Anesthesiologists (ASA) Physical Status I, II, III.
- undergoing transurethral resection of the prostate(TURP)"
Key exclusion criteria (4 listed)
- 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 "
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diastolic function by TTE
Time frame: The participants will be followed for the duration of surgery (TURP), an expected average of 1 hour.
Results and safety
The study was stopped early (reason given: It was difficult to proceed with the study according to the protocol, the research was terminated early.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of BPH, run by Yonsei University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: It was difficult to proceed with the study according to the protocol, the research was terminated early.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diastolic function by TTE (time frame: The participants will be followed for the duration of surgery (TURP), an expected average of 1 hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2019.