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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674996
Recruitment Status : Enrolling by invitation
First Posted : September 18, 2018
Last Update Posted : November 2, 2018
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

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%.

Condition or disease Intervention/treatment Phase
Prostate Cancer Other: Same day discharge Other: Next-day discharge Other: 2-days discharge Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Safety and Security Evaluation of Patients Submitted to Minimally Invasive Radical Prostatectomy
Actual Study Start Date : March 22, 2017
Estimated Primary Completion Date : November 30, 2018
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Same day discharge
Patients submitted to minimally invasive radical prostatectomy, and discharged 12 hours after the surgery.
Other: Same day discharge
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.
Other: Next-day discharge
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group

2-days discharge
Patients submitted to minimally invasive radical prostatectomy, and discharged 48 hours after the surgery.
Other: 2-days discharge
Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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).


  2. 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.


  3. 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):

    • 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).

  4. 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.




Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674996


Locations
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Brazil
Nucleo de Apoio ao Pesquisador
Barretos, Sao Paulo, Brazil, 14784400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
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Principal Investigator: Eliney F Faria, MD Barretos Cancer Hospital
  Study Documents (Full-Text)

Documents provided by Barretos Cancer Hospital:
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Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT03674996    
Other Study ID Numbers: Discharge after prostatectomy
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: November 2, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barretos Cancer Hospital:
Prostatectomy
Patient satisfaction
Questionnaire
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases