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OpenTrials
Completed

NCT Number: NCT01955863

Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations

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.

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Key information

Age range

40 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Barretos' Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

patient discharge on postoperative day 2

Procedure

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

patient discharge on postoperative day 1

Procedure

The patient was discharge on postoperative day 1

patient discharge in the day of surgery

Procedure

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

Primary outcomes

  1. 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?

Sponsors and collaborators

Lead sponsor

Wesley Justino Magnabosco

Other

Registry information

Official study title

Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study

Acronym: ORP-SAC

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Oct 8, 2013
Registry last updated
Jan 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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