Transnasal Endoscopy in Obese Patients Are Candidates for Bariatric Surgery: Feasibility, Tolerance, Security and Cost-effectiveness.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Feasibility of the procedure
研究概览
简要总结
Transnasal Endoscopy in Obese Patients are Candidates for Bariatric Surgery
Introduction and Objectives: high digestive endoscopy (HDE) is an important tool in the preoperative period of bariatric surgery. Patients with excess weight have a higher risk of cardiorespiratory complications during this procedure, being that the transnasal endoscopy (TNE) with an endoscope-thin is a safe alternative, comfortable and great value for money. The TNE allows the study of the upper gastrointestinal tract without the need for sedation. The objective of this work was to evaluate the feasibility, tolerance and safety of TNE in obese patients are candidates for bariatric surgery. Methods: This was a prospective study with all patients with indication for surgery of obesity undergoing endoscopic transnasal preoperatively, between December 2016 and August 2018, at the Hospital of the Federal University of Minas Gerais. The variables evaluated were: age, gender, suitability of the exam, tolerance by the patient through the visual analogue scale, incidence of complications and need for sedation. Oxygen saturation, heart rate and systolic blood pressure were recorded. Conclusion: The transnasal endoscopy is a feasible alternative, well tolerated and safe the conventional endoscopy in evolution the preoperative bariatric surgery. The benefits of transnasal endoscopy in obese patients mainly consist in carrying out the procedure without sedation, which may provide reduction of risks, costs and waive the need for a companion. Key words: transnasal endoscopy - Obesity - endoscopy without sedation.
详细描述
-
- Introduction - scientific background, relevance and rationale of the research
According to data from 2014 of the World Health Organization (WHO), globally there are more than 1.9 billion adults are overweight and at least 600 million obese. 39% of adults above 18 years were overweight and 13% were obese that year. According to the WHO classification, the population with overweight is one that has a body mass index (BMI) greater than or equal to 25 kg/m² and has a BMI greater than or equal to 30 Kg/m² is obese.
In Brazil, the excess weight also assumes epidemic proportions. The most recent survey of the Ministry of Health (MH) conducted in 2014 found that more than half of the Brazilian population is overweight (52.5%) and of these, 17.9% are obese. The prevalence of obesity has doubled during the period between 1980 and 2014 in Brazil. The data are disclosed annually by MH since 2006. Obesity and overweight are considered risk factors relevant to chronic diseases such as diabetes mellitus type 2, cardiovascular diseases and malignant neoplasms.
Among the various treatment modalities, the bariatric surgery is an effective remedy in cases of morbid obesity with a failure of clinical treatment, giving patients a reduction of mortality rates and resolution of clinical comorbidities, as was demonstrated in an observational study of ten years of follow-up.
The reason for indication of high digestive endoscopy (HDE) in the pre-operative bariatric surgery refers to the detection and/or treatment of injuries that could affect the type of proposed surgery, causing complications in the immediate postoperative period or result in symptoms after surgery. However, the endoscopic examination of routine pre-operative in these patients is controversial if there is no gastrointestinal symptoms studies. One of the reasons for this, concerns the increased cardiovascular risk of obese subjects associated with sedation. In Brazil as well as in other centers, the guidelines recommend HDE with research of Helicobacter pylori infection in all patients preoperatively of bariatric surgery. The traditional HDE involves the use of conscious sedation, with a mortality rate of 0.03% and morbidity of 0.54%. Adverse cardiopulmonary related to sedation and analgesia equivalent to about 60% of the complications of high digestive endoscopy, and such complications are more frequent in obese patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- 否
入选标准
- •A BMI greater than or equal to 40 Kg/m²
- •A BMI greater or equal 35 Kg/m² associated with comorbidity (e.g., arterial hypertension, diabetes, dyslipidemia, sleep apnea)
排除标准
- •Surgery, fractures or nasal malformations
- •History of epistaxis
- •Allergy to components of the topical anesthetic used prior to the examination
- •Coagulation disorders or use of anticoagulants
- •Pregnancy
- •Psychiatric disorder important
研究组 & 干预措施
Obese patients
Obese patients undergoing Local Anesthetics and Transnasal Endoscopy.
干预措施: Local Anesthetics,Topical (Drug)
Obese patients
Obese patients undergoing Local Anesthetics and Transnasal Endoscopy.
干预措施: transnasal endoscopy (Procedure)
结局指标
主要结局
Feasibility of the procedure
时间窗: 15 minutes
The exam will be considered feasible if the appliance reaches the second duodenal portion and is performed retroflexão, allowing the visualization of all portions of the digestive system and the achievement of biopsies if necessary. All patients will complete a questionnaire 15 to 30 minutes after the transnasal endoscopy and will be released next to the house. All of this information and the results will be compared with the main data in the literature. Bivariate analyzes shall be calculated from the test "t" test for continuous variables and the chi-square test or Fisher exact test for categorical variables. Proportions will be reported by categorical data; and mean, median and standard deviation for continuous variables. P values less than 0.05 are considered statistically significant.
次要结局
未报告次要终点
研究者
Amaury Teixeira Xavier
Principal Investigator
Federal University of Minas Gerais