Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy

NCT ID: NCT03674996

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2019-12-23

Brief 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%.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Same day discharge

Patients submitted to minimally invasive radical prostatectomy, and discharged 12 hours after the surgery.

Group Type: EXPERIMENTAL

Same day discharge

Intervention Type: OTHER

Discharge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group

Next-day discharge

Patients submitted to minimally invasive radical prostatectomy, and discharged 24 hours after the surgery.

Group Type: EXPERIMENTAL

Next-day discharge

Intervention Type: OTHER

Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group

2-days discharge

Patients submitted to minimally invasive radical prostatectomy, and discharged 48 hours after the surgery.

Group Type: OTHER

2-days discharge

Intervention Type: OTHER

Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group

Interventions

Same day discharge

Discharge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group

Intervention Type: OTHER

Next-day discharge

Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group

Intervention Type: OTHER

2-days discharge

Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Localized Prostate Cancer
• BMI ≤ 35
• Specific Prostate Antigen ≤ 30 ng/ml
• Gleason score ≤ 7
• Hemoglobin ≤ 12g/dl
• American Society of Anesthesiologists Score ≤ 2
• Absence of psychiatric disease

Exclusion Criteria

• Perioperative results with estimated blood loss > 750 ml
• Blood transfusion need
• Operative time > 4 hours
• Nausea or vomiting at the discharge
• Uncontrollable pain at the discharge
• Postural hypotension

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eliney F Faria, MD

Role: PRINCIPAL_INVESTIGATOR

Barretos Cancer Hospital

Locations

Nucleo de Apoio ao Pesquisador

Barretos, São Paulo, Brazil

Countries

Brazil

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

Discharge after prostatectomy

Identifier Type: -

Identifier Source: org_study_id