Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations (ORP-SAC)
Outpatient Radical Prostatectomy - Surgical and Anesthetic Considerations - Open Label Randomized Pilot Study
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
São Paulo
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Barretos, São Paulo, Brasilia, 14784400
- Barretos' Cancer Hospital
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Tehtävätehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: patient discharge on postoperative day 2
The patient was discharge on postoperative day 2 (as was done routinely)
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The patient was discharge on postoperative day 2 (as was done routinely)
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Kokeellinen: patient discharge on postoperative day 1
The patient was discharge on postoperative day 1
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The patient was discharge on postoperative day 1
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Kokeellinen: 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)
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The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Feasibility of ambulatory open radical prostatectomy while maintaining patient satisfaction and safety.
Aikaikkuna: 2 weeks postoperatively
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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?
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2 weeks postoperatively
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Igor RM Franklin, MD, Barretos' Cancer Hospital
- Opintojen puheenjohtaja: Eliney F Faria, PhD, Barretos' Cancer Hospital
- Opintojohtaja: Wesley J Magnabosco, MD, Barretos' Cancer Hospital
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- OORP-2011
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