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Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations

NCT01955863 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2016-01-14

No results posted yet for this study

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.

Conditions

  • Prostatic Neoplasms

Interventions

PROCEDURE

patient discharge on postoperative day 2

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

PROCEDURE

patient discharge on postoperative day 1

The patient was discharge on postoperative day 1

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)

Sponsors & Collaborators

  • Wesley Justino Magnabosco

    lead OTHER

Principal Investigators

  • Igor RM Franklin, MD · Barretos' Cancer Hospital

  • Eliney F Faria, PhD · Barretos' Cancer Hospital

  • Wesley J Magnabosco, MD · Barretos' Cancer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-11-30
Completion
2012-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01955863 on ClinicalTrials.gov