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The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy

Primary Purpose

Prostatic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
General Anaesthesia
Combined (Epidural and Spinal) Anaesthesia
Open Retropubic Radical Prostatectomy
Sponsored by
Sismanoglio General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasm

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sismanoglio General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

General Anaesthesia

Combined (Epidural and Spinal) Anaesthesia

Arm Description

Patients undergoing open retropubic radical prostatectomy under general anaesthesia

Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia

Outcomes

Primary Outcome Measures

Blood Pressure Change
Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.
Heart Rate Change
Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.
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.
Blood Loss During Surgery
Measured from suction contents intra-operatively in ml
Haemoglobin Change
Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL
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
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).
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)
Change From Baseline PSA Levels at 6-months
Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value
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

Secondary Outcome Measures

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.
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?"
Total Hospital Stay
Days until patient discharge from the hospital.
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"

Full Information

First Posted
September 27, 2022
Last Updated
October 1, 2022
Sponsor
Sismanoglio General Hospital
Collaborators
National and Kapodistrian University of Athens
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1. Study Identification

Unique Protocol Identification Number
NCT05566405
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 27, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
September 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sismanoglio General Hospital
Collaborators
National and Kapodistrian University of Athens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
General Anaesthesia
Arm Type
Active Comparator
Arm Description
Patients undergoing open retropubic radical prostatectomy under general anaesthesia
Arm Title
Combined (Epidural and Spinal) Anaesthesia
Arm Type
Active Comparator
Arm Description
Patients undergoing open retropubic radical prostatectomy under combined (epidural and spinal) anaesthesia
Intervention Type
Procedure
Intervention Name(s)
General Anaesthesia
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Combined (Epidural and Spinal) Anaesthesia
Intervention Description
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%).
Intervention Type
Procedure
Intervention Name(s)
Open Retropubic Radical Prostatectomy
Intervention Description
All patients will undergo a nerve-sparing open retropubic radical prostatectomy
Primary Outcome Measure Information:
Title
Blood Pressure Change
Description
Measurement of patients systolic and diastolic blood pressure during the operation and post-operatively for 72 hours.
Time Frame
Peri-operatively
Title
Heart Rate Change
Description
Measurement of patients Heart Rate during the operation and post-operatively for 72 hours.
Time Frame
Peri-operatively
Title
Surgical APGAR Score
Description
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.
Time Frame
Peri-operatively
Title
Blood Loss During Surgery
Description
Measured from suction contents intra-operatively in ml
Time Frame
Peri-operatively
Title
Haemoglobin Change
Description
Haemoglobin measurement before the operation and at 12-, 24- and 48-hours post-operatively, in g/dL
Time Frame
Peri-operatively
Title
Operation Time
Description
Time required for: Induction of anaesthesia Completion of the operation Post-operative time until the patient is successfully transferred to the recovery room
Time Frame
Peri-operatively
Title
Pain Assessed by the VAS Scale
Description
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).
Time Frame
Peri-operatively
Title
Complication Rate
Description
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)
Time Frame
Peri-operatively and up to 1 year after the operation
Title
Change From Baseline PSA Levels at 6-months
Description
Measurement of Prostatic Specific Antigen (PSA) levels at 6 to establish a PSA nadir value
Time Frame
6 months post-operative
Title
Change from 6-month PSA Levels at 12-months
Description
Measurement of Prostatic Specific Antigen (PSA) levels at 12 post-operation to detect any biochemical recurrence
Time Frame
12 months post-operative
Secondary Outcome Measure Information:
Title
Change from Baseline Erectile Function after Radical Prostatectomy
Description
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.
Time Frame
Up to 1 year after the operation
Title
Post-operative Urinary Incontinence
Description
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?"
Time Frame
1 year after the operation
Title
Total Hospital Stay
Description
Days until patient discharge from the hospital.
Time Frame
Peri-operative
Title
Patient Satisfaction Assessed by the Short Assessment of Patient Satisfaction (SAPS) Questionnaire
Description
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"
Time Frame
Peri-operative

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Konstantinos Pikramenos, MD
Organizational Affiliation
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iraklis Mitsogiannis, Assoc. Prof.
Organizational Affiliation
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ioannis Varkarakis, Prof.
Organizational Affiliation
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Athanasios Papatsoris, Prof.
Organizational Affiliation
2nd Urology Department, Sismanoglio Hospital, National and Kapodistrian University of Athens
Official's Role
Study Chair
Facility Information:
Facility Name
Sismanoglio General Hospital
City
Maroúsi
State/Province
Attiki
ZIP/Postal Code
15126
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Available from the corresponding author on reasonable request.
IPD Sharing Time Frame
On reasonable request after completion of study and analysis.
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
35020204
Citation
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Results Reference
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Citation
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Results Reference
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16985892
Citation
Lepor H. A review of surgical techniques for radical prostatectomy. Rev Urol. 2005;7 Suppl 2(Suppl 2):S11-7.
Results Reference
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17254923
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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.
Results Reference
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PubMed Identifier
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Citation
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Results Reference
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PubMed Identifier
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Citation
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The Effects of Method of Anaesthesia on the Safety and Effectiveness of Radical Retropubic Prostatectomy

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