Benign Prostate HyperplasiaNCT02483819
Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients
An observational study of Benign Prostate Hyperplasia, run by Yonsei University.
Trial summary
The purpose of this study is to evaluate the change of the hemodynamic profiles on bio reactance technique during TURP in elderly patients. Read more about this study
- Who is it for?
- Ages 65 to 80 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2015to 27 Feb 2016
- 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 80 years
- Men only
- No healthy volunteers
- Older adult
Study population: elderly patients undergoing transurethral resection of the prostate under spinal anesthesia
Who may be able to join
- 1) Twenty (ASA status I ~ III) patients, ages 65 to 80 yr old, who were scheduled for transurethral resection of the prostate under spinal anesthesia
Who cannot join
- if there were contraindications for spinal anesthesia including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
- history of coronary artery bypass surgery
- history of dementia
- have a difficulty in understanding informed consent or refuse to sign the informed consent
- patients height under 150 cm
About this study
The purpose of this study is to evaluate the change of the hemodynamic profiles on bio reactance technique during TURP in elderly patients.
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- Elderly patient, NICOM, TURP
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients
(Cardiac output, stroke volume, Stroke volume index, Total peripheral resistance, heart rate, blood pressure)
Measured: change from baseline 1 min before the anesthesia, 10 min after anesthesia, 10 min after surgery, 20 min after surgery, 30 min after surgery, at the end of the surgery
Secondary outcomes (4)
change of the electrolyte
Measured: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
change of the hemoglobin
Measured: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
estimated absorbed irrigation fluid during the surgery
Fluid absorbed = % decrease in sodium x ECF (0.2 x body weight)
Measured: during the surgery
incidence of TURP syndrome
Measured: followed for the duration of hospital stay, an expected average of 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study start2 Jul 2015
- Primary completion27 Feb 2016
- Study completion27 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate HyperplasiaStudies 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
- 20 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
- NCT02483819
- Sponsor's protocol ID
- 4-2015-0362
- Status last verified
- Jan 2017
- First submitted
- 18 Jun 2015
- Last updated
- 25 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of the Hemodynamic Profiles on Bio Reactance Technique During TURP in Elderly Patients
- ClinicalTrials.gov ID
- NCT02483819
- Acronym / sponsor ID
- 4-2015-0362
- Conditions
- Benign Prostate Hyperplasia
- Keywords
- Elderly patient, NICOM, TURP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 2 Jul 2015 (actual)
- Primary completion
- 27 Feb 2016 (actual)
- Study completion
- 27 Feb 2016 (actual)
- First posted
- 29 Jun 2015 (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.
The purpose of this study is to evaluate the change of the hemodynamic profiles on bio reactance technique during TURP in elderly patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly patients undergoing transurethral resection of the prostate under spinal anesthesia
Key inclusion criteria (1 listed)
- 1) Twenty (ASA status I ~ III) patients, ages 65 to 80 yr old, who were scheduled for transurethral resection of the prostate under spinal anesthesia
Key exclusion criteria (5 listed)
- if there were contraindications for spinal anesthesia including hypersensitivity to any local anaesthetics, bleeding diathesis, infections at the puncture sites, or pre-existing neurological disease.
- history of coronary artery bypass surgery
- history of dementia
- have a difficulty in understanding informed consent or refuse to sign the informed consent
- patients height under 150 cm
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
change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients
Time frame: change from baseline 1 min before the anesthesia, 10 min after anesthesia, 10 min after surgery, 20 min after surgery, 30 min after surgery, at the end of the surgery
(Cardiac output, stroke volume, Stroke volume index, Total peripheral resistance, heart rate, blood pressure)
4 secondary outcomes
change of the electrolyte
Time frame: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
change of the hemoglobin
Time frame: from expected up to 3 months before surgery for preoperative evaluation to expected up to 3 hours after the end of surgery
estimated absorbed irrigation fluid during the surgery
Time frame: during the surgery
incidence of TURP syndrome
Time frame: followed for the duration of hospital stay, an expected average of 7 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2017.
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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 Benign Prostate Hyperplasia, 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 25 Jan 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change of the hemodynamic profiles including cardiac index on NICOM during the TURP in elderly patients (time frame: change from baseline 1 min before the anesthesia, 10 min after anesthesia, 10 min after surgery, 20 min after surgery, 30 min after surgery, at the end of the surgery). 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 25 Jan 2017.