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临床试验/NCT04486417
NCT04486417Unknown不适用

Feasibility of a Telematics Pre-operative Assessment in a Bariatric Center of Excellence During Covid-19 Phase 2: a Prospective Observational Study

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Drop out rate

研究概览

简要总结

Coronavirus (COVID-19) is a respiratory disease caused by a newly discovered coronavirus, SARS-CoV-2. Several recent papers on the pandemic recognized obesity as a risk factor for the COVID-19 infection. Therefore, an effective treatment for obesity even during COVID-19 outbreak is needed. Bariatric surgery, is considered an effective treatment in the reduction of obesity-related comorbidities and mortality risk. However, during Covid-19 phase 1 (lockdown) the near totality of elective non-oncologic procedures, including bariatric surgery, has been postponed, and all the outpatients' visits too. Therefore, phase 1 led to completely change the way of managing the pre-operative multidisciplinary visits considering the hospital limitation access and the restriction. In the present study the investigators explored the use of telemedicine as a possible strategy to face this new situation.

Specifically, this study aims to test the efficacy of an online structured protocol based on pre-operative multidisciplinary assessment using telemedicine instruments. In particular, the primary end point is to test the feasibility of a telematics pre-operative work-up. The secondary end points are evaluating patient's compliance and satisfaction to the online assessment.

详细描述

Coronavirus (COVID-19) is a respiratory disease caused by a newly discovered coronavirus, SARS-CoV-2. In Italy the first person-to-person transmission was reported on February, 21, 2020. The North of Italy, became the epicentre of the outbreak in Europe, and Italy was one of the most affected Country in the World. As May, 5, 2020 the total number of positive Covid-19 in Italy was 212532, with 27400 deaths. Several recent papers on the pandemic recognized obesity as a risk factor for the COVID-19 infection. Furthermore, the Centre for Disease and Control Prevention report that people with diabetes, liver disease, chronic lung disease and cardiovascular disease are at higher risk for greater severity of COVID-19, and these are the most common obesity-related comorbidities too. In New York out of 3615 subjects with SARS-CoV-2 positive swab between March 4, and April 4, 21% had BMI 30-34 and 16% had BMI > 35.

This foreword underlines the need to guarantee gold standard treatment for obesity even during COVID-19 outbreak, including bariatric surgery, considered an effective treatment in the reduction of obesity-related comorbidities and mortality risk.

On March 9, 2020 started the phase 1 (lockdown) and the near totality of elective non-oncologic procedures has been postponed (including bariatric procedures) to increase capacity for in-patient beds and acute care.

The efforts during the unexpected and unexplored phase 1 were addressed how to properly prepare the phase 2, started on May,4, 2020. In fact, the Phase 1 led to completely change the way of managing the pre-operative multidisciplinary outpatient's visits considering the hospital limitation access and the restriction.

All the possible remote contact with patients has been explored, in order to face this new situation. The first challenge was: how to continue to support our patients seeking treatment of morbid obesity. Considering the lack of effective treatment for Covid-19 and the possibility of a new epidemic peak, new strategies to assess and treat morbid obesity patients are needed.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • not being positive to Covid-19 (according to Covid-19 telephone interview)
  • age >18 and <65 years
  • availability of a stable internet connection
  • having a mailbox and possibility to send and receive pdf documents via e-mail

排除标准

  • Not having a stable internet connection and a mailbox
  • not having practicality with telematic tools
  • having possible Covid-19 symptoms (according to Covid-19 telephone interview)

结局指标

主要结局

Drop out rate

时间窗: 1 month

The drop out rate will be calculated (% of people who drop out during the assessment procedure)

Rejection rate (%)

时间窗: During the recruitment process

The rejection rate to the online assessment modality will be calculated (% of people who refuse to participate to the online assessment procedure).

次要结局

  • Satisfaction degree(3 weeks)
  • Excess Weight Loss percentage (EWL%)(1 month)

研究者

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gianfranco Silecchia

Full Professor

University of Roma La Sapienza

研究点 (1)

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