- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03674996
Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sao Paulo
-
Barretos, Sao Paulo, Brazil, 14784400
- Nucleo de Apoio ao Pesquisador
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Same day discharge
Patients submitted to minimally invasive radical prostatectomy, and discharged 12 hours after the surgery.
|
Discharge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group
|
EXPERIMENTAL: Next-day discharge
Patients submitted to minimally invasive radical prostatectomy, and discharged 24 hours after the surgery.
|
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group
|
OTHER: 2-days discharge
Patients submitted to minimally invasive radical prostatectomy, and discharged 48 hours after the surgery.
|
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Satisfaction of the patients: SATIS-BR
Time Frame: 48 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fail index
Time Frame: 48 months
|
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
|
Factors that influence the patients' satisfaction: SATIS-BR
Time Frame: 48 months
|
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
|
Assessment of how the patient feels about early discharge through an inventory
Time Frame: 48 months
|
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):
|
48 months
|
Questionnaire assessing the patient´s satisfaction levels regarding the length of hospital stay
Time Frame: 48 months
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Eliney F Faria, MD, Barretos Cancer Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Discharge after prostatectomy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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