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

W

Wesley Justino Magnabosco

Status

Completed

Conditions

Prostatic Neoplasms

Treatments

Procedure: patient discharge in the day of surgery
Procedure: patient discharge on postoperative day 1
Procedure: patient discharge on postoperative day 2

Study type

Interventional

Funder types

Other

Identifiers

NCT01955863
OORP-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

45 participants in 3 patient groups

patient discharge on postoperative day 2
Active Comparator group
Description:
The patient was discharge on postoperative day 2 (as was done routinely)
Treatment:
Procedure: patient discharge on postoperative day 2
patient discharge on postoperative day 1
Experimental group
Description:
The patient was discharge on postoperative day 1
Treatment:
Procedure: patient discharge on postoperative day 1
patient discharge in the day of surgery
Experimental group
Description:
The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
Treatment:
Procedure: patient discharge in the day of surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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