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临床试验/NCT04480034
NCT04480034Unknown不适用

Laparoscopic Bariatric Surgery During Phase 2-3 Covid-19 Pandemic in Italy: a Multicenter, Prospective, Observational Study.

University of Roma La Sapienza1 个研究点 分布在 1 个国家目标入组 1,600 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
1,600
试验地点
1
主要终点
Postoperative COVID-19 infection

研究概览

简要总结

The first person-to-person Coronavirus disease (COVID-19) transmission in Italy was reported on Feb 21st, 2020, causing one of the most massive outbreak in Europe so far that stopped immediately all elective surgical procedures. Bariatric surgery represents the most effective treatment to obtain an important, long-term weight loss and comorbidities' resolution, including respiratory disorders. A sensitive decrease of epidemic has been observed lately and a gradual and progressive stop of the lockdown (phase 2-3) was planned, when the virus is supposed to be under control and protocols are guiding the restart of the elective bariatric surgery. Several questions are currently open: Laparoscopic bariatric surgery is safe in the phase 2-3? What's the expected complications rate? The actual hospital protocols are effective to minimize the risk of postoperative COVID-19 infection? Aim: to analyse results of bariatric surgery during phase 2-3 COVID-19 pandemic in Italy. Primary end point: 30 days COVID-19 infection, mortality and complications. Secondary end points: readmission rate 30 days, reoperations for any reason related to surgery. Study design: prospective multicenter observational. Setting: Italian National Health Service 8 high-volume bariatric centres. Enrollment criteria: No previous Covid-19 infection; Primary, standard IFSO approved bariatric procedures; No concomitant procedure; No previous major abdominal surgery; >18<60 years old; Compensated comorbidities; Official SICOB's surgical informed consent given, including COVID-19 addendum; Adherence to very restrictive protocols regarding: hospital admission, management of in-hospital patients and after discharge. Follow-up: scheduled outpatient visit 30th postoperative day. Data evaluation: all the cases performed during July/December 2020 will be collected in a prospective database. Patients operated during the period July/December 2019 in the same centers will be considered comparative group (control). Expected results: Transparent information to the patients, and the introduction of the COVID-19 protocol concerning patients and health-professionals protection, should guarantee a safe restart of bariatric surgery in Italy. The network of 8 high-volume centers sharing information and protocols in this "unexplored" period will be a guarantee for patients' safety. Bariatric surgery should induce a postoperative amelioration of the comorbidities reducing the risks in case of a second outbreak.

详细描述

Background Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) . The disease was first identified in December 2019 in Wuhan, the capital of China's Hubei province, and has since spread globally, resulting in the ongoing 2019-20 coronavirus pandemic . As of 08.05.2020, more than 3.91 million cases have been reported across 185 countries and territories, resulting in more than 218,000 deaths. More than 1.344.000 people have recovered . Even though there are very few available data on BMI for patients with COVID-19 infections, the role of obesity in the COVID-19 epidemic must not be ignored. A recent study on patients admitted in China for pneumonia from SARS-CoV-2, showed that obesity is associated with higher risks to develop severe pneumonia, especially in men . Obesity plays an important role in the pathogenesis of COVID-19 infection . In fact, the immune system, which is a key player in the pathogenesis of COVID-19, also plays an important role in obesity-induced adipose tissue inflammation. This inflammation of adipose tissue results in metabolic dysfunction potentially leading to dyslipidaemia, insulin resistance, type 2 diabetes mellitus, hypertension, and cardiovascular disease. A systematic review and meta-analysis demonstrated that severe obesity (body mass index BMI ≥ 40 kg/m2) represents a major risk factor of intensive care unit admission or death in individuals affected by H1N1 influenza . Thereafter, obesity is associated with a higher risk of infectious diseases, in particular of the respiratory tract.

There are a number of factors predisposing subjects with obesity to viral infections. These factors include low-grade chronic inflammation with hyper-production of pro-inflammatory cytokines, reduced natural killer (NK) cell number and activity, altered CD4:CD8T cell balance, impaired response to antigen stimulation and high expression of adipocyte angiotensin type 1 and 2 receptors.

Furthermore, obesity is associated with, and responsible for, comorbidity conditions that may represent risk factors for serious COVID-19 infection (i.e. type II diabetes, ischemic cardiac disease, etc.). Extra attention and precautions for patients with obesity during this epidemic is recommended. Whenever COVID-19 infection is suspected, screening must be systematic, particularly if the patient has obesity.

So far, bariatric surgery represents the most effective treatment to obtain a long-term meaningful weight reduction and resolution of comorbidities including respiratory disorders. In a very large case series study including 56277 subjects who underwent bariatric surgery in the United States, the overall risk of developing common infectious diseases including respiratory infections decreased significantly in men during the first two years after surgery (aOR, 0.69 [95% CI, 0.60-0.79]; P<0.001).

The first person-to-person transmission in Italy was reported on February 21st, 2020, in Lombardy region, the most crowded and rich region in Italy, causing the most massive Covid-19 outbreak in Europe so far. First positive cases of Sars-Co-v-2 were registered in Italy by 29th of January 2020. The COVID-19 outbreak stopped all elective surgical procedures by 9th of March, including bariatric/metabolic surgery except emergency conditions as suggested by recent IFSO recommendations . All elective surgical and endoscopic cases for metabolic and bariatric surgery should be postponed during the phase one outbreak. This would minimize risks to both patient and healthcare team, as well as reducing the utilization of unnecessary resources, such as beds, ventilators and personal protective equipment (PPE). In addition, postponing these services will minimize potential exposure of the COVID-19 virus to unsuspecting healthcare providers and patients.

研究设计

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

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Primary bariatric surgery;
  • Compensated DMT2;
  • Controlled hypertension;
  • Patients with OSAS can only be admitted if therapy with home CPAP is effective
  • Laparoscopic standard bariatric procedure;
  • Procedure duration less than 120 minutes;
  • Official SICOB's surgical informed consent given, including Covid-19 addendum.

排除标准

  • previous Covid-19 infection;
  • patients who may need an extended stay or intensive care (BMI > 60).
  • concomitant procedure;
  • previous major abdominal surgery

结局指标

主要结局

Postoperative COVID-19 infection

时间窗: 30 postoperative days

Postbariatric surgery COVID-19 infection, mortality and complications

次要结局

  • Complications related to bariatric surgery(30 postoperative days)

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

MD, PhD, Full Professor of Surgery

University of Roma La Sapienza

研究点 (1)

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