Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations

NCT01955863 | Completed

• 1 other identifier: OORP-2011
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Neoplasms

Keywords

Prostatic Neoplasms; Prostatectomy, Retropubic; Patient Discharge

Outcome Measures

Primary Outcomes (1)

• Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.

  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?

  2 weeks postoperatively

Study Arms (3)

patient discharge on postoperative day 2

ACTIVE COMPARATOR

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

Procedure: patient discharge on postoperative day 2

patient discharge on postoperative day 1

EXPERIMENTAL

The patient was discharge on postoperative day 1

Procedure: patient discharge on postoperative day 1

patient discharge in the day of surgery

EXPERIMENTAL

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

Procedure: patient discharge in the day of surgery

Interventions

patient discharge on postoperative day 2 PROCEDURE

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

patient discharge on postoperative day 2

patient discharge on postoperative day 1 PROCEDURE

The patient was discharge on postoperative day 1

patient 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)

patient discharge in the day of surgery

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Important comorbidities
• history of bleeding diathesis
• taking blood thinners

Sponsors & Collaborators

• Wesley Justino Magnabosco: lead

Study Sites (1)

Barretos' Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Patient Discharge

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Continuity of Patient Care; Patient Care; Therapeutics; Hospitalization; Health Services; Health Care Facilities Workforce and Services; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Igor RM Franklin, MD

  Barretos' Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Eliney F Faria, PhD

  Barretos' Cancer Hospital

  STUDY CHAIR

• Wesley J Magnabosco, MD

  Barretos' Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: member of urological team

Study Record Dates

• First Submitted: September 25, 2013
• First Posted: October 8, 2013
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: January 14, 2016

Record last verified: 2016-01

Locations

BR (1)