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临床试验/NCT03088332
NCT03088332已完成不适用

Prospective Multicenter Study to Evaluate the Efficacy and Results of Endoscopic Gastroplasty Performed Using Overstitch in Patients With Class I and II Obesity.

Kaiser Clinic and Hospital3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
3
主要终点
Weight loss

研究概览

简要总结

Obesity is a chronic disease that has grown to epidemic characteristics in Brazil and around the world in recent years. Treatment for patients with class III or class II obesity with comorbidities is already well established, with bariatric surgery being the best option. However, there is no consensus as to the best treatment for cases of class I and class II obesity without comorbidities. The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.

详细描述

The objective of this research will be to make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures. The secondary objective will be to correlate demographic, endoscopic and laboratory data with the results of this procedure.

Patients and Methods: Patients with class I obesity with or without comorbidities and patients with class II obesity without comorbidities, irrespective of gender and ethnic background, from the state of São Paulo and other states of the country will be submitted to vertical endoscopic gastroplasty. The procedures will be performed at the Endoscopy Service of the Mario Covas Hospital in São Paulo, SP. Data collection will be performed at the same location.

Information will be obtained during the outpatient follow-up at the Hospital Mario Covas including demographic (gender, age), clinical (height, weight, time after procedure, systemic arterial hypertension, diabetes, dyslipidemia, smoking, alcohol consumption) and operative data (complications).

Preparation for the procedure: All the exams will be performed at the Hospital Mario Covas after the patients have fasted for at least 8 hours. The procedure will begin with the patient in left lateral decubitus under general anesthesia performed by an anesthesiologist. Endoscopic sutures will be performed using 2-0 prolene thread until a tubular-shaped stomach is formed similar to a vertical gastrectomy.

Recovery after the procedure: After the procedure and recovery from anesthesia, all patients will be discharged but only together with a companion. All patients will receive guidance and will remain in touch with a physician to report any adverse signs or symptoms.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •BMI > 30 and < 36 with or without comorbidities
  • •BMI > 36 and < 40 without comorbidities

排除标准

  • •Prior gastric surgery
  • •Use of anticoagulants
  • •Psychiatric disorders
  • •Severe esophagitis

研究组 & 干预措施

Endoscopic gastroplasty

Experimental

Make a gastric tube similar to that obtained in surgical gastroplication however it will be created using intragastric endoscopic sutures.

干预措施: Endoscopic gastroplasty (Procedure)

结局指标

主要结局

Weight loss

时间窗: 48 weeks

Weight in Kg and Body Mass Index (BMI) in kilograms by meters squared

次要结局

  • Hb1AC(48 weeks)
  • Fasting blood glucose(48 weeks)
  • Procedural complications(At the time of procedure and at 6 months and 1 year follow-up period)
  • Blood count(48 weeks)
  • Cholesterol(48 weeks)

研究者

发起方
Kaiser Clinic and Hospital
申办方类型
Other
责任方
Sponsor

研究点 (3)

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