Prostatic NeoplasmsORP-SACNCT01955863
Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations
A study testing patient discharge on postoperative day 2, patient discharge on postoperative day 1 and patient discharge in the day of surgery in people with Prostatic Neoplasms, run by Wesley Justino Magnabosco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- patient discharge on postoperative day 2, patient discharge on postoperative day 1 and patient discharge in the day of surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2011to Jan 2012
- 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 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Important comorbidities
- history of bleeding diathesis
- taking blood thinners
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study
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.
Read the 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.
- Conditions
- Prostatic Neoplasms
- Being tested
- patient discharge on postoperative day 2, patient discharge on postoperative day 1, patient discharge in the day of surgery
- Keywords
- Prostatic Neoplasms, Prostatectomy, Retropubic, Patient Discharge
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient discharge on postoperative day 2Procedure or surgery
The patient was discharge on postoperative day 2 (as was done routinely)
patient discharge on postoperative day 1Procedure or surgery
The patient was discharge on postoperative day 1
patient discharge in the day of surgeryProcedure or surgery
The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
| Study group | Role | What they receive |
|---|---|---|
| patient discharge on postoperative day 2 | Active comparator | The patient was discharge on postoperative day 2 (as was done routinely) Receives: Procedure: patient discharge on postoperative day 2 |
| patient discharge on postoperative day 1 | Experimental | The patient was discharge on postoperative day 1 Receives: Procedure: patient discharge on postoperative day 1 |
| patient discharge in the day of surgery | Experimental | The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization) Receives: Procedure: patient discharge in the day of surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 2 weeks postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study startMar 2011
- Primary completionNov 2011
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic NeoplasmsStudies 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wesley Justino Magnabosco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wesley Justino Magnabosco, Barretos Cancer Hospital
- Investigators
- Igor RM Franklin, MD, Principal investigator, Barretos' Cancer HospitalEliney F Faria, PhD, Study chair, Barretos' Cancer HospitalWesley J Magnabosco, MD, Study director, Barretos' Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01955863
- Sponsor's protocol ID
- OORP-2011
- Acronym
- ORP-SAC
- Status last verified
- Jan 2016
- First submitted
- 25 Sep 2013
- Last updated
- 14 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01955863
- Acronym / sponsor ID
- ORP-SAC / OORP-2011
- Conditions
- Prostatic Neoplasms
- Keywords
- Prostatic Neoplasms, Prostatectomy, Retropubic, Patient Discharge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Wesley Justino MagnaboscoUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 8 Oct 2013 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient discharge on postoperative day 2 | Active comparator | Procedure: patient discharge on postoperative day 2The patient was discharge on postoperative day 2 (as was done routinely) |
| patient discharge on postoperative day 1 | Experimental | Procedure: patient discharge on postoperative day 1The patient was discharge on postoperative day 1 |
| patient discharge in the day of surgery | Experimental | Procedure: patient discharge in the day of surgeryThe patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization) |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Important comorbidities
- history of bleeding diathesis
- taking blood thinners
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 |
|---|---|---|
| patient discharge on postoperative day 2The patient was discharge on postoperative day 2 (as was done routinely) | Procedure or surgery | patient discharge on postoperative day 2 |
| patient discharge on postoperative day 1The patient was discharge on postoperative day 1 | Procedure or surgery | patient discharge on postoperative day 1 |
| patient discharge in the day of surgeryThe patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization) | Procedure or surgery | patient discharge in the day of surgery |
Primary outcome
Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.
Time frame: 2 weeks postoperatively
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?
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 14 Jan 2016.
Related trials for Prostatic Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
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.
Igor RM Franklin, MD principal investigator
Barretos' Cancer Hospital
Eliney F Faria, PhD study chair
Barretos' Cancer Hospital
Wesley J Magnabosco, MD study director
Barretos' Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing patient discharge on postoperative day 2, patient discharge on postoperative day 1 and patient discharge in the day of surgery in people with Prostatic Neoplasms, run by Wesley Justino Magnabosco at 1 site in Brazil.
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 4 inclusion and 3 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 14 Jan 2016. 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 Brazil. 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?
Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety. (time frame: 2 weeks postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Jan 2016.