Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This project aims to evaluate safety and security of patients submitted to minimally invasive
      radical prostatectomy, who received discharge from hospital in the same day of the surgery
      (Group I), on the 1st post-surgery day (Group II) and in the 2nd post-surgery day (Group III
      - control). The specific aims are the evaluation of fail index and factors that influence the
      permanence in the hospital, the satisfaction of patients, the perception of security of
      patient, the index of post-discharge complications and the costs related to different times
      of hospitalization. On randomization, those patients in Group I must match the early hospital
      discharge criteria defined in the study. Thus, they will be forwarded to "Casa de Apoio Madre
      Paulina", where will receive nursing care until the next day when, in the morning, will be
      reevaluated in the ambulatory of urology from Barretos Cancer Hospital. The patients of Group
      II will be evaluated in the ambulatory in the 2nd post-surgery day, before the discharge. In
      the Group III (control), the patients will be discharged in the 2nd post-surgery day (routine
      of Barretos Cancer Hospital). All patients who accept to be enrolled in the study will sign
      the Consent Term previously the surgery. At the 10th post-surgery day, in the follow-up, it
      will be applied the Patients' Satisfaction with Mental Health Services Scale (SATIS-BR)
      questionnaire and an inventory. The data will be descriptive considering average, standard
      deviation, minimum and maximum value and quartile to the quantitative variables and frequency
      tables to the qualitative variables. In order to determine the groups' homogeneity, some
      sociodemographic and clinical characteristics will be compared. To the qualitative variables,
      it will be used chi-squared test (of Fishers exact test), and to the quantitative variables
      it will be used variance analysis (or Kruskal-Wallis test). The patients' satisfaction will
      be measured using SATIS-BR, which consists in three numeric domains (ranging from 1 to 5).
      The comparison of each domain among the groups will be performed using ANOVA. Then, linear
      regression will be performed in order to analyze the relationship of the patients'
      characteristics influencing the satisfaction. The rates of fail, clinical security, security
      perception and post-discharge complications will be compared among the groups using
      chi-squared test (of Fisher's exact test). There will be considered the significance level of
      5%.
    


Intervention name(s): Same day discharge; Next-day discharge; 2-days discharge
Intervention type(s): Other; Other; Other
Intervention description(s): Discharge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group; Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group; Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Prostatectomy; Patient satisfaction; Questionnaire