search
Back to results

Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations (ORP-SAC)

Primary Purpose

Prostatic Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
patient discharge on postoperative day 2
patient discharge on postoperative day 1
patient discharge in the day of surgery
Sponsored by
Wesley Justino Magnabosco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Prostatic Neoplasms, Prostatectomy, Retropubic, Patient Discharge

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • clinically localized Prostate Cancer (PCa)
  • underwent open radical retropubic prostatectomy at Barretos' Cancer Hospital by a single primary surgeon (EFF)
  • patients which the procedure went without any complications
  • body mass index ≤ 30 kg/m2

Exclusion Criteria:

  • Important comorbidities
  • history of bleeding diathesis
  • taking blood thinners

Sites / Locations

  • Barretos' Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

patient discharge on postoperative day 2

patient discharge on postoperative day 1

patient discharge in the day of surgery

Arm Description

The patient was discharge on postoperative day 2 (as was done routinely)

The patient was discharge on postoperative day 1

The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)

Outcomes

Primary Outcome Measures

Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.
The endpoint regarding the survey is the comparison with standard group discharged at postoperative day 2. The satisfaction was considered non similar when there were more than 1 negative answer for any question or any patient in comparison to standard group in these questions: Do you consider your postoperative care adequate ? / Was your understanding of the necessary postoperative care adequate before enrolling for this study? Was your pain control adequate? / Was the length of hospitalization adequate? / Would you choose to have the procedure again with the same length of hospitalization? / Did you take any analgesic postoperatively after being discharged? / Did you take any analgesic postoperatively after being discharged? / Have you received adequate medical and nurse's care during the post-operative period? / Did you consider the access to the hospital easy if you needed it? / Would you recommend other men undergo this procedure the same way you?

Secondary Outcome Measures

Full Information

First Posted
September 25, 2013
Last Updated
January 13, 2016
Sponsor
Wesley Justino Magnabosco
search

1. Study Identification

Unique Protocol Identification Number
NCT01955863
Brief Title
Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations
Acronym
ORP-SAC
Official Title
Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wesley Justino Magnabosco

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Radical prostatectomy has become the gold standard treatment for prostate cancer. Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers around the world start to develop laparoscopic and robotic approach over the past years. The problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep learning curve with a high initial complication rate, and the use of robotic assistance surgery despite of lower learning curve is associated with higher surgical supply and operative room costs. These costs may have a significant impact on overall cost of prostate cancer care especially in Brazil. In Brazil, the open route for radical prostatectomy is still the most frequent approach. One of the disadvantages of open prostatectomy from the other surgeries is the longest hospital stay. However, the question of what length of stay after this operation is optimal and necessary is unresolved. In this trial the investigators have compared a randomized group of patients that had discharged on postoperative day 2, 1 and same day surgery. The investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy (patient discharge in the same day of surgery - average 12 hours of hospitalization) maintaining patient satisfaction and safety.
Detailed Description
Radical prostatectomy initially described by Walsh (1982) has become the gold standard treatment for prostate cancer and has evolved enormously over the last 25 years. Improvements include the use of smaller incisions, reduced blood loss, shorter hospital stays, and surgical refinement. Several large series with long-term follow-up have confirmed that this approach results in excellent cancer control and functional results in terms of preservation of erectile potency and urinary continence. Regarding of morbidity of access on open retropubic radical prostatectomy a lot of centers around the world start to develop laparoscopic and robotic approach over the past years. The problems regarding this techniques is that the pure laparoscopic prostatectomy shows a steep learning curve with a high initial complication rate, and the use of robotic assistance surgery despite of lower learning curve is associated with higher surgical supply and operative room costs. These costs may have a significant impact on overall cost of prostate cancer care especially in Brazil where nowadays only have 3 centers with 5 robots. In Brazil, the open route for radical prostatectomy is still the most frequent approach, mainly out of large cities. One of the disadvantages of open prostatectomy from minimally invasive surgeries is the longest hospital stay. However, the question of what length of stay after this operation is optimal and necessary is unresolved. In this trial the investigators have compared a randomized group of patients that had discharged on postoperative day 2, 1 and same day surgery. The investigators had intent to evaluate the feasibility of ambulatory open radical prostatectomy (patient discharge in the same day of surgery - average 12 hours of hospitalization) while maintaining patient satisfaction and safety.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasms
Keywords
Prostatic Neoplasms, Prostatectomy, Retropubic, Patient Discharge

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
patient discharge on postoperative day 2
Arm Type
Active Comparator
Arm Description
The patient was discharge on postoperative day 2 (as was done routinely)
Arm Title
patient discharge on postoperative day 1
Arm Type
Experimental
Arm Description
The patient was discharge on postoperative day 1
Arm Title
patient discharge in the day of surgery
Arm Type
Experimental
Arm Description
The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
Intervention Type
Procedure
Intervention Name(s)
patient discharge on postoperative day 2
Intervention Description
The patient was discharge on postoperative day 2 (as was done routinely)
Intervention Type
Procedure
Intervention Name(s)
patient discharge on postoperative day 1
Intervention Description
The patient was discharge on postoperative day 1
Intervention Type
Procedure
Intervention Name(s)
patient discharge in the day of surgery
Intervention Description
The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
Primary Outcome Measure Information:
Title
Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.
Description
The endpoint regarding the survey is the comparison with standard group discharged at postoperative day 2. The satisfaction was considered non similar when there were more than 1 negative answer for any question or any patient in comparison to standard group in these questions: Do you consider your postoperative care adequate ? / Was your understanding of the necessary postoperative care adequate before enrolling for this study? Was your pain control adequate? / Was the length of hospitalization adequate? / Would you choose to have the procedure again with the same length of hospitalization? / Did you take any analgesic postoperatively after being discharged? / Did you take any analgesic postoperatively after being discharged? / Have you received adequate medical and nurse's care during the post-operative period? / Did you consider the access to the hospital easy if you needed it? / Would you recommend other men undergo this procedure the same way you?
Time Frame
2 weeks postoperatively

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: clinically localized Prostate Cancer (PCa) underwent open radical retropubic prostatectomy at Barretos' Cancer Hospital by a single primary surgeon (EFF) patients which the procedure went without any complications body mass index ≤ 30 kg/m2 Exclusion Criteria: Important comorbidities history of bleeding diathesis taking blood thinners
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Igor RM Franklin, MD
Organizational Affiliation
Barretos' Cancer Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eliney F Faria, PhD
Organizational Affiliation
Barretos' Cancer Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Wesley J Magnabosco, MD
Organizational Affiliation
Barretos' Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Barretos' Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784400
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations

We'll reach out to this number within 24 hrs