Prostate CancerNCT01905488
Perioperative Changes of Cognitive Function According to Jugular Vein Insufficiency in Robot-assisted Prostatectomy
An observational study of Prostate Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve system to prevent retrograde blood flow to the brain. Anatomical studies revealed that bicuspid or tricuspid valves were located in both jugular veins 2 cm above the subclavia-jugulars bifurcation and 7-18% of the valves were… Read more about this study
- Who is it for?
- Ages 56 to 78 years, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Nov 2009
- 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 56 to 78 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who were over 50 years old with ASA class I or II, scheduled for robot-assisted laparoscopic prostatectomy
Who may be able to join
- over 50 years old
- ASA class I or II
- Scheduled for robot assisted laparoscopic prostatectomy
Who cannot join
- previous neurologic deficit
- history of psychiatric disease, alcoholism or other drug dependency
- Serious hearing or visual impairment or any other comorbidities which would preclude neuropsychological tests
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Seoul, 120-752
About this study
Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve system to prevent retrograde blood flow to the brain. Anatomical studies revealed that bicuspid or tricuspid valves were located in both jugular veins 2 cm above the subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence (IJVVI) may result in retrograde flow which leads to brain congestion and increase of intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been reported to be associated with transient global amnesia (TGA), cough syncope, exertional headache, transient ischemic attack, and air embolism. Demographic data are associated with the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension. Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery because of its significant benefits such as smaller incision, less severe postoperative pain, less intraoperative bleeding, and shorter hospital stay compared to traditional radical prostatectomy. The patients undergoing RLP are mostly over 60 years old, have neurologic, cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg position most of the time during surgery, which could cause increases in intra-abdominal and intrathoracic pressure.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
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 |
|---|---|---|
| Group N | patients who didn't show internal jugula vein valve incompetency (IJVVI) | |
| Group PT | patients who showed IJVVI after pneumoperitoneum or Trendelenburg position | |
| Group S | patients who showed IJVVI in supine position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of neurocognitive function from baseline at 2 days after surgery
Six neurocognitive function tests( 1. Mini-Mental State Examination 2. Auditory Verbal Learning Test 3. Digit Symbol Substitution Test 4. Color Word Stroop Test 5. Digit Span Test 6. Grooved Pegboard Test ) were performed 1 day before surgery as a baseline, then 2 days after surgery as primary outcome parameters. The values between 2 observations were compared to evaluated th neurocognitive dysfunction between groups separated by the presence of IJVVI.
Measured: 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2013 (estimated)
- Study startMay 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT01905488
- Sponsor's protocol ID
- 4-2009-0056
- Status last verified
- Jul 2013
- First submitted
- 16 Jul 2013
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Akkawi NM, Agosti C, Borroni B, Rozzini L, Magoni M, Vignolo LA, Padovani A. Jugular valve incompetence: a study using air contrast ultrasonography on a general population. J Ultrasound Med. 2002 Jul;21(7):747-51. doi: 10.7863/jum.2002.21.7.747.
PubMed 12099562Silva MA, Deen KI, Fernando DJ, Sheriffdeen AH. The internal jugular vein valve may have a significant role in the prevention of venous reflux: evidence from live and cadaveric human subjects. Clin Physiol Funct Imaging. 2002 May;22(3):202-5. doi: 10.1046/j.1475-097x.2002.00418.x.
PubMed 12076346Dresser LP, McKinney WM. Anatomic and pathophysiologic studies of the human internal jugular valve. Am J Surg. 1987 Aug;154(2):220-4. doi: 10.1016/0002-9610(87)90185-1.
PubMed 3631396Sander D, Winbeck K, Etgen T, Knapp R, Klingelhofer J, Conrad B. Disturbance of venous flow patterns in patients with transient global amnesia. Lancet. 2000 Dec 9;356(9246):1982-4. doi: 10.1016/S0140-6736(00)03313-4.
PubMed 11130530Nedelmann M, Eicke BM, Dieterich M. Increased incidence of jugular valve insufficiency in patients with transient global amnesia. J Neurol. 2005 Dec;252(12):1482-6. doi: 10.1007/s00415-005-0894-9. Epub 2005 Jul 7.
PubMed 15999232Maalikjy Akkawi N, Agosti C, Anzola GP, Borroni B, Magoni M, Pezzini A, Rozzini L, Vignolo LA, Padovani A. Transient global amnesia: a clinical and sonographic study. Eur Neurol. 2003;49(2):67-71. doi: 10.1159/000068501.
PubMed 12584412
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Changes of Cognitive Function According to Jugular Vein Insufficiency in Robot-assisted Prostatectomy
- ClinicalTrials.gov ID
- NCT01905488
- Acronym / sponsor ID
- 4-2009-0056
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 23 Jul 2013 (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.
Internal jugular vein (IJV) is the main pathway of cerebral venous drainage and it has valve system to prevent retrograde blood flow to the brain. Anatomical studies revealed that bicuspid or tricuspid valves were located in both jugular veins 2 cm above the subclavia-jugulars bifurcation and 7-18% of the valves were incompetent. IJVV incompetence (IJVVI) may result in retrograde flow which leads to brain congestion and increase of intracranial pressure, which can cause brain dysfunctions in some patients. IJVVI has been reported to be associated with transient global amnesia (TGA), cough syncope, exertional headache, transient ischemic attack, and air embolism. Demographic data are associated with the development of IJVVI. Akkawi et al. demonstrated that old age over 50 years and male gender are the risk factors for IJVVI. A few physiologic conditions are related with IJVVI including elevated intra-thoracic and intra-abdominal pressure, and pulmonary hypertension. Robot assisted laparoscopic prostatectomy (RLP) is one of the most common robotic surgery because of its significant benefits such as smaller incision, less severe postoperative pain, less intraoperative bleeding, and shorter hospital stay compared to traditional radical prostatectomy. The patients undergoing RLP are mostly over 60 years old, have neurologic, cardiac and pulmonary comorbidities. For RLP, patients are in Trendelenburg position most of the time during surgery, which could cause increases in intra-abdominal and intrathoracic pressure.
Study design
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group N | – | –patients who didn't show internal jugula vein valve incompetency (IJVVI) |
| Group PT | – | –patients who showed IJVVI after pneumoperitoneum or Trendelenburg position |
| Group S | – | –patients who showed IJVVI in supine position |
Who may qualify
- Ages
- 56 to 78 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were over 50 years old with ASA class I or II, scheduled for robot-assisted laparoscopic prostatectomy
Key inclusion criteria (3 listed)
- over 50 years old
- ASA class I or II
- Scheduled for robot assisted laparoscopic prostatectomy
Key exclusion criteria (3 listed)
- previous neurologic deficit
- history of psychiatric disease, alcoholism or other drug dependency
- Serious hearing or visual impairment or any other comorbidities which would preclude neuropsychological tests
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 neurocognitive function from baseline at 2 days after surgery
Time frame: 2 days after surgery
Six neurocognitive function tests( 1. Mini-Mental State Examination 2. Auditory Verbal Learning Test 3. Digit Symbol Substitution Test 4. Color Word Stroop Test 5. Digit Span Test 6. Grooved Pegboard Test ) were performed 1 day before surgery as a baseline, then 2 days after surgery as primary outcome parameters. The values between 2 observations were compared to evaluated th neurocognitive dysfunction between groups separated by the presence of IJVVI.
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 23 Jul 2013.
- Background: PubMed 12099562Akkawi NM, Agosti C, Borroni B, Rozzini L, Magoni M, Vignolo LA, Padovani A. Jugular valve incompetence: a study using air contrast ultrasonography on a general population. J Ultrasound Med. 2002 Jul;21(7):747-51. doi: 10.7863/jum.2002.21.7.747.
- Background: PubMed 12076346Silva MA, Deen KI, Fernando DJ, Sheriffdeen AH. The internal jugular vein valve may have a significant role in the prevention of venous reflux: evidence from live and cadaveric human subjects. Clin Physiol Funct Imaging. 2002 May;22(3):202-5. doi: 10.1046/j.1475-097x.2002.00418.x.
- Background: PubMed 3631396Dresser LP, McKinney WM. Anatomic and pathophysiologic studies of the human internal jugular valve. Am J Surg. 1987 Aug;154(2):220-4. doi: 10.1016/0002-9610(87)90185-1.
- Background: PubMed 11130530Sander D, Winbeck K, Etgen T, Knapp R, Klingelhofer J, Conrad B. Disturbance of venous flow patterns in patients with transient global amnesia. Lancet. 2000 Dec 9;356(9246):1982-4. doi: 10.1016/S0140-6736(00)03313-4.
- Background: PubMed 15999232Nedelmann M, Eicke BM, Dieterich M. Increased incidence of jugular valve insufficiency in patients with transient global amnesia. J Neurol. 2005 Dec;252(12):1482-6. doi: 10.1007/s00415-005-0894-9. Epub 2005 Jul 7.
- Background: PubMed 12584412Maalikjy Akkawi N, Agosti C, Anzola GP, Borroni B, Magoni M, Pezzini A, Rozzini L, Vignolo LA, Padovani A. Transient global amnesia: a clinical and sonographic study. Eur Neurol. 2003;49(2):67-71. doi: 10.1159/000068501.
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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.
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 Yonsei University 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 3 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 23 Jul 2013. 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?
Change of neurocognitive function from baseline at 2 days after surgery (time frame: 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01905488, which also lists 6 linked publications.
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 23 Jul 2013.