Clinical trial NCT01955863: Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations
Official title: Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Neoplasms
Keywords: Prostatic Neoplasms
Prostatectomy, Retropubic
Patient Discharge
Lead sponsor: Barretos Cancer Hospital
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 45
Sex: MALE
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.
timeFrame: 2 weeks postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Barretos
country: Brazil
facility: Barretos' Cancer Hospital
state: São Paulo
Study officials:
affiliation: Barretos' Cancer Hospital
name: Igor RM Franklin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Barretos' Cancer Hospital
name: Eliney F Faria, PhD
role: STUDY_CHAIR
affiliation: Barretos' Cancer Hospital
name: Wesley J Magnabosco, MD
role: STUDY_DIRECTOR
References: