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临床试验/NCT03674996
NCT03674996已完成不适用

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

Barretos Cancer Hospital2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2017年3月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
2
主要终点
Satisfaction of the patients: SATIS-BR

研究概览

简要总结

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%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
40 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Localized Prostate Cancer
  • Specific Prostate Antigen ≤ 30 ng/ml
  • Gleason score ≤ 7
  • Hemoglobin ≤ 12g/dl
  • American Society of Anesthesiologists Score ≤ 2
  • Absence of psychiatric disease

排除标准

  • 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

结局指标

主要结局

Satisfaction of the patients: SATIS-BR

时间窗: 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.

次要结局

  • Fail index(48 months)
  • Factors that influence the patients' satisfaction: SATIS-BR(48 months)
  • Assessment of how the patient feels about early discharge through an inventory(48 months)
  • Questionnaire assessing the patient´s satisfaction levels regarding the length of hospital stay(48 months)

研究者

发起方
Barretos Cancer Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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