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

NCT03674996 | Completed DMC

• 1 other identifier: Discharge after prostatectomy
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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

Keywords

Prostatectomy; Patient satisfaction; Questionnaire

Outcome Measures

Primary Outcomes (1)

• Satisfaction of the patients: SATIS-BR

  This outcome will be evaluated through SATIS-BR questionnaire The unabbreviated scale name is "Escala da avaliação da satisfação dos usuários " ("Scale of evaluation of satisfaction of patients", in free English). The questionnaire contains 39 questions, with possible answers arranged in a Likert scale of 5 points, in which the value 1 indicates the lowest degree of satisfaction (worst outcome) and the value 5 indicates the highest degree of satisfaction (best outcome) with the service. The analysis will be performed in each question individually. The comparison of each question among groups will be performed using Analysis of Variance (ANOVA). Subsequently, Linear Regression will be used to verify the joint relationship among the characteristics of patients with the group influencing satisfaction. Additionally, there are 5 qualitative questions that will be analyzed in relation to factors that influence hospital stay and factors that influence the patients' satisfaction.

  48 months

Secondary Outcomes (4)

• Fail index

  48 months

• Factors that influence the patients' satisfaction: SATIS-BR

  48 months

• Assessment of how the patient feels about early discharge through an inventory

  48 months

• Questionnaire assessing the patient´s satisfaction levels regarding the length of hospital stay

  48 months

Study Arms (3)

Same day discharge

EXPERIMENTAL

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

Other: Same day discharge

Next-day discharge

EXPERIMENTAL

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

Other: Next-day discharge

2-days discharge

OTHER

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

Other: 2-days discharge

Interventions

Same day discharge OTHER

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

Same day discharge

Next-day discharge OTHER

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

Next-day discharge

2-days discharge OTHER

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

2-days discharge

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Nucleo de Apoio ao Pesquisador

Barretos, São Paulo, 14784400, Brazil

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Patient Satisfaction

Interventions

Drainage

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Eliney F Faria, MD

  Barretos Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2018
• First Posted: September 18, 2018
• Study Start: March 22, 2017
• Primary Completion: December 23, 2019
• Study Completion: December 23, 2019
• Last Updated: February 8, 2023

Record last verified: 2020-06

Locations

BR (1)