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

B

Barretos Cancer Hospital

Status

Completed

Conditions

Prostate Cancer

Treatments

Other: Next-day discharge
Other: 2-days discharge
Other: Same day discharge

Study type

Interventional

Funder types

Other

Identifiers

NCT03674996
Discharge after prostatectomy

Details and patient eligibility

About

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%.

Enrollment

72 patients

Sex

Male

Ages

40 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

72 participants in 3 patient groups

Same day discharge
Experimental group
Description:
Patients submitted to minimally invasive radical prostatectomy, and discharged 12 hours after the surgery.
Treatment:
Other: Same day discharge
Next-day discharge
Experimental group
Description:
Patients submitted to minimally invasive radical prostatectomy, and discharged 24 hours after the surgery.
Treatment:
Other: Next-day discharge
2-days discharge
Other group
Description:
Patients submitted to minimally invasive radical prostatectomy, and discharged 48 hours after the surgery.
Treatment:
Other: 2-days discharge

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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