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| Name | Class |
|---|---|
| National and Kapodistrian University of Athens | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General Anaesthesia | Active Comparator | Patients undergoing open retropubic radical prostatectomy under general anaesthesia |
|
| Combined (Epidural and Spinal) Anaesthesia | Active Comparator | Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| General Anaesthesia | Procedure | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure Change | Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours. | Peri-operatively |
| Heart Rate Change | Measurement of patients Heart Rate during the operation and post-operatively for 72 hours. | 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:
| Peri-operatively |
| Blood Loss During Surgery | Measured from suction contents intra-operatively in ml | Peri-operatively |
| Haemoglobin Change | Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL | Peri-operatively |
| Operation Time | Time required for:
| Peri-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
Results will be:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Pikramenos, MD | 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens | Principal Investigator |
| Iraklis Mitsogiannis, Assoc. Prof. | 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens | Study Director |
| Ioannis Varkarakis, Prof. | 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens | Study Chair |
| Athanasios Papatsoris, Prof. | 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sismanoglio General Hospital | Marousi | Attica | 15126 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35020204 | Background | 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. | |
| 23035261 | Background | Hatzinger 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. |
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Available from the corresponding author on reasonable request.
On reasonable request after completion of study and analysis.
Any medical researcher on an official capacity will be eligible to submit a request to the primary investigator of the study. Requests will be considered in due time and relevant information released accordingly.
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D007268 | Injections, Epidural |
| D000758 | Anesthesia |
| ID | Term |
|---|---|
| D000760 | Anesthesia and Analgesia |
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
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|
| Combined (Epidural and Spinal) Anaesthesia | Procedure | 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 Prostatectomy | Procedure | All patients will undergo a nerve-sparing open retropubic radical prostatectomy |
|
| 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). | Peri-operatively |
| Complication Rate | Complications related to the procedure:
Complications related to the anaesthesia technique performed:
| 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 | 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 | 12 months post-operative |
| 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:
| 1 year after the operation |
| Total Hospital Stay | Days until patient discharge from the hospital. | 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" | Peri-operative |
| 16985892 | Background | Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2(Suppl 2):S11-7. |
| 17254923 | Background | Gawande 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. |
| 30211382 | Background | Delgado 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. |
| 28877145 | Background | Hinkelbein 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. |
| 15227649 | Background | Avery 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. |
| 24698296 | Background | Hawthorne 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. |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D004358 |
| Drug Therapy |
| D013812 | Therapeutics |