Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations

NCT ID: NCT01955863

Last Updated: 2016-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-01-31

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.

Conditions

Prostatic Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

patient discharge on postoperative day 2

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

Group Type: ACTIVE_COMPARATOR

patient discharge on postoperative day 2

Intervention Type: PROCEDURE

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

patient discharge on postoperative day 1

The patient was discharge on postoperative day 1

Group Type: EXPERIMENTAL

patient discharge on postoperative day 1

Intervention Type: PROCEDURE

The patient was discharge on postoperative day 1

patient discharge in the day of surgery

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

Group Type: EXPERIMENTAL

patient discharge in the day of surgery

Intervention Type: PROCEDURE

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

Interventions

patient discharge on postoperative day 2

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

Intervention Type: PROCEDURE

patient discharge on postoperative day 1

The patient was discharge on postoperative day 1

Intervention Type: PROCEDURE

patient discharge in the day of surgery

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Wesley Justino Magnabosco

OTHER

Sponsor Role: lead

Responsible Party

Wesley Justino Magnabosco

member of urological team

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Igor RM Franklin, MD

Role: PRINCIPAL_INVESTIGATOR

Barretos' Cancer Hospital

Eliney F Faria, PhD

Role: STUDY_CHAIR

Barretos' Cancer Hospital

Wesley J Magnabosco, MD

Role: STUDY_DIRECTOR

Barretos' Cancer Hospital

Locations

Barretos' Cancer Hospital

Barretos, São Paulo, Brazil

Countries

Brazil

Other Identifiers

OORP-2011

Identifier Type: -

Identifier Source: org_study_id