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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03674996
• Other study ID #: Discharge after prostatectomy
• Status: Completed
• Phase: N/A
• Start date: March 22, 2017
• Est. completion date: December 23, 2019

Study information

• Verified date: June 2020
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Same day discharge
Discharge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group
• Next-day discharge
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group
• 2-days discharge
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group

Locations

Country	Name	City	State
Brazil	Nucleo de Apoio ao Pesquisador	Barretos	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Fail index	This outcome will be assessed by monitoring if the patient randomized did not fill the discharge criteria and/or needed a re-hospitalization; There is no scale for this outcome; It will be reported by the percentage of patients that should be discharged in a specific day, but it was not discharged due to not fulfill one of the discharge criteria (adequate control of postoperative pain, absence of nausea and / or vomiting, absence of bleeding from the drain, being oriented, walking / walking without help from third parties and being able to ingest liquids properly, no hematúria, sero-urinary drainage rate up to 200 ml, no bleeding in the operative wound, release of light diet (liquid) after high anesthetic and recommendation of pasty diet (soups and liquids), prescription and standardization of analgesics and anti-inflammatory drugs (not on a demand schedule).	48 months
Secondary	Factors that influence the patients' satisfaction: SATIS-BR	These outcomes 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	Assessment of how the patient feels about early discharge through an inventory	The inventory was created by the autors in order to evaluate patient´s satisfaction and perception of security, using the specific questions (here, translated to English): What do you think about the hospitalization time in relation to the surgery?; Would you like to have been hospitalized any longer?; Are you satisfied with the type of anesthesia used in your surgery?; After the surgery, how did you feel about the medication prescribed for pain?; Did you feel satisfied with the explanation of the hospital discharge?; In general, how did you feel about satisfaction? The scale has 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). Each question will be analyzed individually. The perception of safety will be compared among the groups using the Chi-Square test (or Fisher's Exact).	48 months
Secondary	Questionnaire assessing the patient´s satisfaction levels regarding the length of hospital stay	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