Prostatic NeoplasmNCT05566405
The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy
A study testing General Anaesthesia, Combined (Epidural and Spinal) Anaesthesia and Open Retropubic Radical Prostatectomy in people with Prostatic Neoplasm, run by Sismanoglio General Hospital at 1 site in Greece.
Trial summary
Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostatic Neoplasm
- What is being tested?
- General Anaesthesia, Combined (Epidural and Spinal) Anaesthesia and Open Retropubic Radical Prostatectomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGreece
- Study dates
- 27 Jul 2020to 30 Sep 2022
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosed with localised prostate cancer
- Eligible for open retropubic radical prostatectomy
Who cannot join
- Metastatic prostate cancer
- History of severe heart disease
- History of haemostasis disorders
- History of previous pelvic surgery
- History of lung disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of the Effects of Combined Spinal Anaesthesia and General Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy in Patients With Localised Prostate Cancer
Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. The open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred.
In this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.
- Conditions
- Prostatic Neoplasm
- Being tested
- General Anaesthesia, Combined (Epidural and Spinal) Anaesthesia, Open Retropubic Radical Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General AnaesthesiaProcedure or surgery
All patients in the general anaesthesia group will be premedicated with intravenously administered (iv) midazolam (2mg) and fentanyl (100 mcg). Induction will be performed using intravenous propofol (2.5-3mg/kg) and lidocaine (40mg); dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg will also be administered. After successful tracheal intubation, total intravenous anaesthesia will be maintained by administering propofol (0.05 mg/kg/sec iv) and remifentanil (0.2 mcg/kg/sec iv). Pain management will be achieved by paracetamol (1g iv) and tramadol (100mg iv) whereas muscle relaxation by vecuronium (0.6 mg/kg iv).
Combined (Epidural and Spinal) AnaesthesiaProcedure or surgery
Combined (epidural and spinal) anaesthesia will be performed using an epidural 18G needle and a spinal 27G needle, in the L2-L3 or L3-L4 interspace. Induction will be carried out by spinal intrathecal administration of levobupivacaine (2.6-3ml of 0.5%) and mild sedation by midazolam (5mg iv in bolus). All patients will be administered dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg iv. Maintenance will be performed 75 minutes after induction and obtained using an epidural administration of levobupivacaine (4-5ml of 0.5%).
Open Retropubic Radical ProstatectomyProcedure or surgery
All patients will undergo a nerve-sparing open retropubic radical prostatectomy
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia | Active comparator | Patients undergoing open retropubic radical prostatectomy under general anaesthesia Receives: Procedure: General Anaesthesia; Procedure: Open Retropubic Radical Prostatectomy |
| Combined (Epidural and Spinal) Anaesthesia | Active comparator | Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia Receives: Procedure: Combined (Epidural and Spinal) Anaesthesia; Procedure: Open Retropubic Radical Prostatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure Change
Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.
Measured: Peri-operatively
Heart Rate Change
Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.
Measured: Peri-operatively
Surgical APGAR Score
Calculation of the Surgical APGAR score for each patient during surgery. The lower the score, on a scale of 1-10, the worst the prognosis of the patient.
SAS is calculated using three variables:
- Estimated blood loss (on a 0-3 scale, 0 points >1000 ml, 1 point 601-1000ml, 2 points 101-600 ml, 3 points <100ml)
- Lowest mean arterial pressure (on a 0-3 scale, 0 points <40 mmHg, 1 point 40-54 mmHg, 2 points 55-69 mmHg, 3 points >70 mmHg)
- Lowest heart rate (on a 0-4 scale, 0 points >85 bpm, 1 points 76-85 bpm, 2 points 66-75 bmp, 3 points 56-65 bmp, 4 points <55 bmp) during surgery.
Measured: Peri-operatively
Blood Loss During Surgery
Measured from suction contents intra-operatively in ml
Measured: Peri-operatively
Haemoglobin Change
Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL
Measured: Peri-operatively
Operation Time
Time required for:
- Induction of anaesthesia
- Completion of the operation
- Post-operative time until the patient is successfully transferred to the recovery room
Measured: Peri-operatively
Pain Assessed by the VAS Scale
Measured using a pain Visual Analogue Scale (VAS) at 6-, 24- and 48-hours after the operation.
VAS is a self-reporting pain scale based on a 0 to 10-point system, with each point measuring 10mm on a linear line. Every patient was asked to indicate his pain levels from "No Pain" (equals 0) to "Worst Pain Imaginable" (equals 10).
Measured: Peri-operatively
Complication Rate
Complications related to the procedure:
- Intraoperative bleeding
- Post-operative bleeding
- Bowel perforation
- Cardiovascular
- Respiratory
Complications related to the anaesthesia technique performed:
- Post-operative headache
- Nausea and vomiting
- Any signs of potential nerve damage (manifested as inability to gain leg motility)
Measured: Peri-operatively and up to 1 year after the operation
Change From Baseline PSA Levels at 6-months
Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value
Measured: 6 months post-operative
Change from 6-month PSA Levels at 12-months
Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence
Measured: 12 months post-operative
Secondary outcomes (4)
Change from Baseline Erectile Function after Radical Prostatectomy
Measured using the International Index of Erectile Function (IIEF-5) questionnaires pre-operatively and at 3-, 6- and 12-months post-surgery.
The test is composed of 5 questions with 5 points for each question. Patients are evaluated accordingly:
- Score 22 or more = No Erectile Disfunction
- Score 17-21 = Mild Erectile Disfunction
- Score 12-16 = Mild to moderate Erectile Disfunction
- Score 8-11 = Moderate Erectile Disfunction
- Score 7 or less = Severe Erectile Disfunction
Results will be:
- Analysed and compared to evaluate any potential difference of the two methods of anaesthesia, on post-operational erectile function
- Analysed comparing pre-operation with post-operation questioners overall, to evaluate erectile disfunction after radical prostatectomy regardless of method of anaesthesia.
Measured: Up to 1 year after the operation
Post-operative Urinary Incontinence
Measured using the International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form at 12 months post-surgery.
The Questionnaire is consisted of 4 questions:
- Frequency "How often do you leak urine?" on a scale of 0 (never) to 5 (all the time)
- Amount of leakage "How much urine do you leak?" on a scale to 0 (none) to 3 (a large amount)
- Overall impact on quality of life "How much does it interfere with your life?" on a scale of 0 (not at all) to 10 (a great deal)
- Timing of leakage "When does urine leak?"
Measured: 1 year after the operation
Total Hospital Stay
Days until patient discharge from the hospital.
Measured: Peri-operative
Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire
Satisfaction, using the Short Assessment of Patient Satisfaction (SAPS) Questionnaire, is measured in a scale of 0 to 28, with 0 to 10 equals to "Very Dissatisfied", 11-18 equals to "Dissatisfied", 19-26 equals to "Satisfied" and 27-28 equals to "Very Satisfied"
Measured: Peri-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start27 Jul 2020
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sismanoglio General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Responsible party
- Principal investigator, Konstantinos Pikramenos, Sismanoglio General Hospital
- Investigators
- Konstantinos Pikramenos, MD, Principal investigator, 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of AthensIraklis Mitsogiannis, Assoc. Prof., Study director, 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of AthensIoannis Varkarakis, Prof., Study chair, 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of AthensAthanasios Papatsoris, Prof., Study chair, 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566405
- Sponsor's protocol ID
- PN 20511/14.10.2020
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available from the corresponding author on reasonable request.
Publications
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
PubMed 35020204Hatzinger M, Hubmann R, Moll F, Sohn M. [The history of prostate cancer from the beginning to DaVinci]. Aktuelle Urol. 2012 Jul;43(4):228-30. doi: 10.1055/s-0032-1324651. German.
PubMed 23035261Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2(Suppl 2):S11-7.
PubMed 16985892Gawande AA, Kwaan MR, Regenbogen SE, Lipsitz SA, Zinner MJ. An Apgar score for surgery. J Am Coll Surg. 2007 Feb;204(2):201-8. doi: 10.1016/j.jamcollsurg.2006.11.011. Epub 2006 Dec 27.
PubMed 17254923Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
PubMed 30211382Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
PubMed 28877145Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
PubMed 15227649Hawthorne G, Sansoni J, Hayes L, Marosszeky N, Sansoni E. Measuring patient satisfaction with health care treatment using the Short Assessment of Patient Satisfaction measure delivered superior and robust satisfaction estimates. J Clin Epidemiol. 2014 May;67(5):527-37. doi: 10.1016/j.jclinepi.2013.12.010.
PubMed 24698296
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of the Effects of Combined Spinal Anaesthesia and General Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy in Patients With Localised Prostate Cancer
- ClinicalTrials.gov ID
- NCT05566405
- Acronym / sponsor ID
- PN 20511/14.10.2020
- Conditions
- Prostatic Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sismanoglio General HospitalUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 4 Oct 2022 (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.
Prostate cancer is one of the most commonly diagnosed neoplasm in men worldwide. The gold standard of therapy is radical prostatectomy, a wide surgical excision of the neoplasm and can be performed either open, laparoscopic or robotic. The open retropubic approach, still performed today, can be completed under either general anaesthesia or combined (spinal/epidural) anaesthesia without any clear guideline on which one should be preferred.
In this study the investigators aim to evaluate general anaesthesia and combined (spinal/ epidural) anaesthesia in patients undergoing open retropubic radical prostatectomy and define whether these may have an impact on the oncological outcome and safety of the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia | Active comparator | Procedure: General Anaesthesia, Procedure: Open Retropubic Radical ProstatectomyPatients undergoing open retropubic radical prostatectomy under general anaesthesia |
| Combined (Epidural and Spinal) Anaesthesia | Active comparator | Procedure: Combined (Epidural and Spinal) Anaesthesia, Procedure: Open Retropubic Radical ProstatectomyPatients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed with localised prostate cancer
- Eligible for open retropubic radical prostatectomy
Key exclusion criteria (5 listed)
- Metastatic prostate cancer
- History of severe heart disease
- History of haemostasis disorders
- History of previous pelvic surgery
- History of lung disease
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 |
|---|---|---|
| General AnaesthesiaAll patients in the general anaesthesia group will be premedicated with intravenously administered (iv) midazolam (2mg) and fentanyl (100 mcg). Induction will be performed using intravenous propofol (2.5-3mg/kg) and lidocaine (40mg); dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg will also be administered. After successful tracheal intubation, total intravenous anaesthesia will be maintained by administering propofol (0.05 mg/kg/sec iv) and remifentanil (0.2 mcg/kg/sec iv). Pain management will be achieved by paracetamol (1g iv) and tramadol (100mg iv) whereas muscle relaxation by vecuronium (0.6 mg/kg iv). | Procedure or surgery | General Anaesthesia |
| Combined (Epidural and Spinal) AnaesthesiaCombined (epidural and spinal) anaesthesia will be performed using an epidural 18G needle and a spinal 27G needle, in the L2-L3 or L3-L4 interspace. Induction will be carried out by spinal intrathecal administration of levobupivacaine (2.6-3ml of 0.5%) and mild sedation by midazolam (5mg iv in bolus). All patients will be administered dexamethasone 8mg, metoclopramide 10mg and omeprazole 40mg iv. Maintenance will be performed 75 minutes after induction and obtained using an epidural administration of levobupivacaine (4-5ml of 0.5%). | Procedure or surgery | Combined (Epidural and Spinal) Anaesthesia |
| Open Retropubic Radical ProstatectomyAll patients will undergo a nerve-sparing open retropubic radical prostatectomy | Procedure or surgery | Combined (Epidural and Spinal) Anaesthesia, General Anaesthesia |
Primary outcome
Blood Pressure Change
Time frame: Peri-operatively
Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.
Heart Rate Change
Time frame: Peri-operatively
Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.
Surgical APGAR Score
Time frame: Peri-operatively
Calculation of the Surgical APGAR score for each patient during surgery. The lower the score, on a scale of 1-10, the worst the prognosis of the patient. SAS is calculated using three variables: * Estimated blood loss (on a 0-3 scale, 0 points >1000 ml, 1 point 601-1000ml, 2 points 101-600 ml, 3 points <100ml) * Lowest mean arterial pressure (on a 0-3 scale, 0 points <40 mmHg, 1 point 40-54 mmHg, 2 points 55-69 mmHg, 3 points >70 mmHg) * Lowest heart rate (on a 0-4 scale, 0 points >85 bpm, 1 points 76-85 bpm, 2 points 66-75 bmp, 3 points 56-65 bmp, 4 points <55 bmp) during surgery.
Blood Loss During Surgery
Time frame: Peri-operatively
Measured from suction contents intra-operatively in ml
Haemoglobin Change
Time frame: Peri-operatively
Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL
Operation Time
Time frame: Peri-operatively
Time required for: * Induction of anaesthesia * Completion of the operation * Post-operative time until the patient is successfully transferred to the recovery room
Pain Assessed by the VAS Scale
Time frame: Peri-operatively
Measured using a pain Visual Analogue Scale (VAS) at 6-, 24- and 48-hours after the operation. VAS is a self-reporting pain scale based on a 0 to 10-point system, with each point measuring 10mm on a linear line. Every patient was asked to indicate his pain levels from "No Pain" (equals 0) to "Worst Pain Imaginable" (equals 10).
Complication Rate
Time frame: Peri-operatively and up to 1 year after the operation
Complications related to the procedure: * Intraoperative bleeding * Post-operative bleeding * Bowel perforation * Cardiovascular * Respiratory Complications related to the anaesthesia technique performed: * Post-operative headache * Nausea and vomiting * Any signs of potential nerve damage (manifested as inability to gain leg motility)
Change From Baseline PSA Levels at 6-months
Time frame: 6 months post-operative
Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value
Change from 6-month PSA Levels at 12-months
Time frame: 12 months post-operative
Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence
4 secondary outcomes
Change from Baseline Erectile Function after Radical Prostatectomy
Time frame: Up to 1 year after the operation
Post-operative Urinary Incontinence
Time frame: 1 year after the operation
Total Hospital Stay
Time frame: Peri-operative
Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire
Time frame: Peri-operative
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 4 Oct 2022.
- Background: PubMed 35020204Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
- Background: PubMed 23035261Hatzinger M, Hubmann R, Moll F, Sohn M. [The history of prostate cancer from the beginning to DaVinci]. Aktuelle Urol. 2012 Jul;43(4):228-30. doi: 10.1055/s-0032-1324651. German.
- Background: PubMed 16985892Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2(Suppl 2):S11-7.
- Background: PubMed 17254923Gawande AA, Kwaan MR, Regenbogen SE, Lipsitz SA, Zinner MJ. An Apgar score for surgery. J Am Coll Surg. 2007 Feb;204(2):201-8. doi: 10.1016/j.jamcollsurg.2006.11.011. Epub 2006 Dec 27.
- Background: PubMed 30211382Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar.
- Background: PubMed 28877145Hinkelbein J, Lamperti M, Akeson J, Santos J, Costa J, De Robertis E, Longrois D, Novak-Jankovic V, Petrini F, Struys MMRF, Veyckemans F, Fuchs-Buder T, Fitzgerald R. European Society of Anaesthesiology and European Board of Anaesthesiology guidelines for procedural sedation and analgesia in adults. Eur J Anaesthesiol. 2018 Jan;35(1):6-24. doi: 10.1097/EJA.0000000000000683.
- Background: PubMed 15227649Avery K, Donovan J, Peters TJ, Shaw C, Gotoh M, Abrams P. ICIQ: a brief and robust measure for evaluating the symptoms and impact of urinary incontinence. Neurourol Urodyn. 2004;23(4):322-30. doi: 10.1002/nau.20041.
- Background: PubMed 24698296Hawthorne G, Sansoni J, Hayes L, Marosszeky N, Sansoni E. Measuring patient satisfaction with health care treatment using the Short Assessment of Patient Satisfaction measure delivered superior and robust satisfaction estimates. J Clin Epidemiol. 2014 May;67(5):527-37. doi: 10.1016/j.jclinepi.2013.12.010.
- Individual participant dataSharing planned: Yes. Available from the corresponding author on reasonable request.
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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.
Konstantinos Pikramenos, MD principal investigator
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Iraklis Mitsogiannis, Assoc. Prof. study director
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Ioannis Varkarakis, Prof. study chair
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing General Anaesthesia, Combined (Epidural and Spinal) Anaesthesia and Open Retropubic Radical Prostatectomy in people with Prostatic Neoplasm, run by Sismanoglio General Hospital at 1 site in Greece.
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 2 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 4 Oct 2022. 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 Greece. 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?
Blood Pressure Change (time frame: Peri-operatively). The study lists 10 primary outcomes in all. 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 NCT05566405, which also lists 8 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 4 Oct 2022.