Prostate CancerNCT04615494
Internal Carotid Artery Blood Flow in Robot-Assisted Laparoscopic Prostatectomy
An observational study of Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the change of the internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy. Read more about this study
- Who is it for?
- Ages 20 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Position
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2020to 22 Jan 2021
- 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 20 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer
Who may be able to join
- Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer and who are 20 years or older and under 80 years
- Patients who agree to voluntarily participate in this study
- Patients with ASA class 1-2
Who cannot join
- History of diagnosis of cerebrovascular disease
- Patients who refused to participate in clinical studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Change of Internal Carotid Artery Blood Flow During Pneumoperitoneum With Steep Trendelenburg Position in Robot-Assisted Laparoscopic Prostatectomy
The purpose of this study is to evaluate the change of the internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy.
- Conditions
- Prostate Cancer
- Being tested
- Position
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PositionProcedure or surgery
Pneumoperitoneum with Steep Trendelenburg position
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in internal carotid artery blood flow
Difference between the internal carotid artery blood flow measured at 10 minutes after anesthetic induction during supine position and the internal carotid artery blood flow measured at 10 minutes after pneumoperitoneum with steep Trendelenburg position
Measured: At 10 minutes after pneumoperitoneum with steep Trendelenburg position
Secondary outcomes (5)
Internal carotid artery blood flow
Internal carotid artery blood flow before anesthetic induction
Measured: Baseline (Before anesthetic induction)
Internal carotid artery blood flow
Internal carotid artery blood flow at 10 minutes after anesthetic induction
Measured: At 10 minutes after anesthetic induction
Internal carotid artery blood flow
Internal carotid artery blood flow at 10 minutes after pneumoperitoneum and Trendelenburg position
Measured: At 10 minutes after pneumoperitoneum and Trendelenburg position
Internal carotid artery blood flow
Internal carotid artery blood flow at 30 minutes after pneumoperitoneum and Trendelenburg position
Measured: At 30 minutes after pneumoperitoneum and Trendelenburg position
Internal carotid artery blood flow
Internal carotid artery blood flow during supine position at skin closure
Measured: Procedure (At skin closure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start17 Nov 2020
- Primary completion21 Jan 2021
- Study completion22 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young-Kug Kim, MD, Asan Medical Center
- Investigators
- Young-Kug Kim, Professor, Study chair, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615494
- Sponsor's protocol ID
- 2020-1638
- Status last verified
- Jan 2021
- First submitted
- 3 Nov 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change of Internal Carotid Artery Blood Flow During Pneumoperitoneum With Steep Trendelenburg Position in Robot-Assisted Laparoscopic Prostatectomy
- ClinicalTrials.gov ID
- NCT04615494
- Acronym / sponsor ID
- 2020-1638
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 21 Jan 2021 (actual)
- Study completion
- 22 Jan 2021 (actual)
- First posted
- 4 Nov 2020 (actual)
- 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 internal carotid artery blood flow according to the steep trendelenburg position and pneumoperitoneum in patients undergoing robot-assisted laparoscopic prostatectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer
Key inclusion criteria (3 listed)
- Patients who have undergone robot-assisted laparoscopic prostatectomy with prostate cancer and who are 20 years or older and under 80 years
- Patients who agree to voluntarily participate in this study
- Patients with ASA class 1-2
Key exclusion criteria (2 listed)
- History of diagnosis of cerebrovascular disease
- Patients who refused to participate in clinical studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PositionPneumoperitoneum with Steep Trendelenburg position | Procedure or surgery | – |
Primary outcome
Difference in internal carotid artery blood flow
Time frame: At 10 minutes after pneumoperitoneum with steep Trendelenburg position
Difference between the internal carotid artery blood flow measured at 10 minutes after anesthetic induction during supine position and the internal carotid artery blood flow measured at 10 minutes after pneumoperitoneum with steep Trendelenburg position
5 secondary outcomes
Internal carotid artery blood flow
Time frame: Baseline (Before anesthetic induction)
Internal carotid artery blood flow
Time frame: At 10 minutes after anesthetic induction
Internal carotid artery blood flow
Time frame: At 10 minutes after pneumoperitoneum and Trendelenburg position
Internal carotid artery blood flow
Time frame: At 30 minutes after pneumoperitoneum and Trendelenburg position
Internal carotid artery blood flow
Time frame: Procedure (At skin closure)
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 26 Jan 2021.
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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.
Young-Kug Kim, Professor study chair
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Asan Medical Center at 1 site in South Korea.
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 2 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 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Difference in internal carotid artery blood flow (time frame: At 10 minutes after pneumoperitoneum with steep Trendelenburg position). 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 26 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.