Clinical trial NCT05566405: The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasm
Lead sponsor: Sismanoglio General Hospital
Sponsor class: OTHER
Collaborators: name: National and Kapodistrian University of Athens
First posted: 2022-10-04
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with localised prostate cancer
* Eligible for open retropubic radical prostatectomy

Exclusion Criteria:

* Metastatic prostate cancer
* History of severe heart disease
* History of haemostasis disorders
* History of previous pelvic surgery
* History of lung disease

Primary outcomes:
measure: Blood Pressure Change
timeFrame: Peri-operatively
measure: Heart Rate Change
timeFrame: Peri-operatively
measure: Surgical APGAR Score
timeFrame: Peri-operatively
measure: Blood Loss During Surgery
timeFrame: Peri-operatively
measure: Haemoglobin Change
timeFrame: Peri-operatively
measure: Operation Time
timeFrame: Peri-operatively
measure: Pain Assessed by the VAS Scale
timeFrame: Peri-operatively
measure: Complication Rate
timeFrame: Peri-operatively and up to 1 year after the operation
measure: Change From Baseline PSA Levels at 6-months
timeFrame: 6 months post-operative
measure: Change from 6-month PSA Levels at 12-months
timeFrame: 12 months post-operative
Secondary outcomes:
measure: Change from Baseline Erectile Function after Radical Prostatectomy
timeFrame: Up to 1 year after the operation
measure: Post-operative Urinary Incontinence
timeFrame: 1 year after the operation
measure: Total Hospital Stay
timeFrame: Peri-operative
measure: Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire
timeFrame: Peri-operative
Other outcomes:
Locations:
city: Maroúsi
country: Greece
facility: Sismanoglio General Hospital
state: Attiki
Study officials:
affiliation: 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
name: Konstantinos Pikramenos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
name: Iraklis Mitsogiannis, Assoc. Prof.
role: STUDY_DIRECTOR
affiliation: 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
name: Ioannis Varkarakis, Prof.
role: STUDY_CHAIR
affiliation: 2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
name: Athanasios Papatsoris, Prof.
role: STUDY_CHAIR
References:
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citation: 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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citation: 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.
citation: 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.
citation: 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.
citation: 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.