Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy
Phase: NA
Conditions: Prostate Cancer
Sponsor: Barretos Cancer Hospital

Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical 
Prostatectomy 
 
 
 
 
Daniele Natália Pacharone Bertolini Bidinotto1,2, Eliney Ferreira Faria1* 
1Uro-oncology and Minimally Invasive Surgery Department, Barretos Cancer Hospital; 
2Barretos School of Health Sciences, Dr. Paulo Prata – FACISB;  
 
 
 
 
 
*Correspondence to: 
Dr. Eliney Ferreira Faria, MD, PhD 
Uro-oncology and Minimally Invasive Surgery Department,  
Barretos Cancer Hospital, 
Rua Antenor Duarte Villela, 1331 
CEP 14784 400, Barretos, S. Paulo, Brazil 
Phone/Fax:+551733216600 – Extension 6989 
elineyferreirafaria@yahoo.com.br 
 
 
 
 
 
 
 
 
Document date: April 20, 2018 
 
 

 
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Study Protocol 
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 postsurgery 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 questionnaire SATISBR and an 
inventory. 
 
Statistical Analysis Plan 
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 postsurgery day, 

 
3
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 questionnaire SATISBR 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%.