Prostate CancerNCT03674996
Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy
A study testing Same day discharge, Next-day discharge and 2-days discharge in people with Prostate Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
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). Read more about this study
- Who is it for?
- Ages 40 to 75 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Same day discharge, Next-day discharge and 2-days discharge
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteBrazil
- Study dates
- 22 Mar 2017to 23 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Same day discharge, Next-day discharge, 2-days discharge
- Keywords
- Prostatectomy, Patient satisfaction, Questionnaire
- Medical subject headings
- Prostatic Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Same day dischargeOther
Discharge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group
Next-day dischargeOther
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group
2-days dischargeOther
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group
| Study group | Role | What they receive |
|---|---|---|
| Same day discharge | Experimental | Patients submitted to minimally invasive radical prostatectomy, and discharged 12 hours after the surgery. Receives: Other: Same day discharge |
| Next-day discharge | Experimental | Patients submitted to minimally invasive radical prostatectomy, and discharged 24 hours after the surgery. Receives: Other: Next-day discharge |
| 2-days discharge | Other | Patients submitted to minimally invasive radical prostatectomy, and discharged 48 hours after the surgery. Receives: Other: 2-days discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 months
Secondary outcomes (4)
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).
Measured: 48 months
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.
Measured: 48 months
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).
Measured: 48 months
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.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start22 Mar 2017
- Primary completion23 Dec 2019
- Study completion23 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliney F Faria, MD, Principal investigator, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03674996
- Sponsor's protocol ID
- Discharge after prostatectomy
- Status last verified
- Jun 2020
- First submitted
- 21 Jul 2018
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT03674996
- Acronym / sponsor ID
- Discharge after prostatectomy
- Conditions
- Prostate Cancer
- Keywords
- Prostatectomy, Patient satisfaction, Questionnaire
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 22 Mar 2017 (actual)
- Primary completion
- 23 Dec 2019 (actual)
- Study completion
- 23 Dec 2019 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Same day discharge | Experimental | Other: Same day dischargePatients submitted to minimally invasive radical prostatectomy, and discharged 12 hours after the surgery. |
| Next-day discharge | Experimental | Other: Next-day dischargePatients submitted to minimally invasive radical prostatectomy, and discharged 24 hours after the surgery. |
| 2-days discharge | Other | Other: 2-days dischargePatients submitted to minimally invasive radical prostatectomy, and discharged 48 hours after the surgery. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Localized Prostate Cancer
- BMI ≤ 35
- Specific Prostate Antigen ≤ 30 ng/ml
- Gleason score ≤ 7
- Hemoglobin ≤ 12g/dl
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Same day dischargeDischarge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group | Other | Same day discharge |
| Next-day dischargeDischarge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group | Other | Next-day discharge |
| 2-days dischargeDischarge of the patient 24 hours after the minimally invasive radical prostatectomy - control group | Other | 2-days discharge |
Primary outcome
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.
4 secondary outcomes
Fail index
Time frame: 48 months
Factors that influence the patients' satisfaction: SATIS-BR
Time frame: 48 months
Assessment of how the patient feels about early discharge through an inventory
Time frame: 48 months
Questionnaire assessing the patient´s satisfaction levels regarding the length of hospital stay
Time frame: 48 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eliney F Faria, MD principal investigator
Barretos Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Same day discharge, Next-day discharge and 2-days discharge in people with Prostate Cancer, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of the patients: SATIS-BR (time frame: 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.