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临床试验/NCT01754194
NCT01754194已完成不适用

An Observational Study in Morbidly Obese Patients to Evaluate Laparoscopic Gastric Sleeve Resections and Roux-en-Y Gastric Bypass Surgery in Clinical and Health-Economic Terms

Medtronic - MITG18 个研究点 分布在 1 个国家目标入组 293 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
293
试验地点
18
主要终点
Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

研究概览

简要总结

Study objectives:

  1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery
  2. support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

详细描述

The objectives of this study are the following: to generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery; and to support multi-disciplinary bariatric sites in Germany by providing structured procedure guidelines and training, therefore facilitating procedural adoption, increasing safety and shortening the learning curve for weight-loss surgery.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients aged from 18 to 65 years of age, inclusive
  • BMI > 40 or BMI > 35 with co-morbidities
  • Eligible for weight-loss surgery
  • Planned laparoscopic gastric sleeve resections or Roux-en-Y bypass surgery
  • Insurance approval status: approved
  • Written informed consent

排除标准

  • BMI > 55
  • Planned two-stage procedures
  • Prior bariatric procedures (including gastric banding)
  • Serious mental or physical co-morbidities at the discretion of the Investigator
  • Insurance approval status: rejected

结局指标

主要结局

Quality of Life (QOL) in First Postoperative Year According to EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)

时间窗: 12 Months

The EQ-5D-5L (minimum and maximum values are 0 and 1 respectively) consists of two sections,the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).The EQ-5D descriptive system comprises the following five dimensions: mobility,self-care,usual activities (e.g.,work, study..), pain/discomfort and anxiety/depression with five response levels for each dimension:no problems,slight problems, moderate problems,severe problems and extreme problems.The EQ-5D VAS is a 20 cm vertical scale where patients can mark from 0 (worst health imaginable) to 100 (best health imaginable).The global score at each timepoint is calculated as a composite of the five dimention score and of the VAS health score according to a specific algorithm.The Aurea Under the Curve (AUC) of QOL as assessed by EQ-5D-5L is reported to combine repeated measurements at flexible time intervals between 0 and 12 months post-procedure into a single numeric value.The higher the AUC value is,the better the patient is.

Quality of Life (QOL) in First Postoperative Year According to Bariatric Analysis and Reporting System (BAROS) With the Moorehead-Ardelt Quality of Life Questionnaire II (M-A QoLQ II)

时间窗: 12 months

The BAROS consists of a scoring table that includes three main areas of analysis: weight loss, improvement of medical conditions and M-A QoLQ II. Points are added or subtracted according to changes in these domains. A maximum of three points is given to each domain to evaluate changes after medical or surgical intervention. Points are deducted for complications or reoperations. The M-A QoLQ II assesses six important QoL items (self-esteem, physical activity, social life, work conditions, sexual activity and eating behaviour) on a scale ranging from -0.50 to 0.50 with 0.10 increments to assess each item. The total number of points (range -7 to 9) defines five outcome groups from failure to excellent. The Aurea Under the Curve (AUC) of QOL as assessed by BAROS with M-A QoLQ II is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.

Quality of Life (QOL) in First Postoperative Year According to Impact of Weight on Quality of Life-Lite Questionnaire (IWQOL-Lite)

时间窗: 12 months

The IWQoL-Lite consists of five domains: physical function (11 items), self-esteem (7 items), sexual life (4 items), public distress (5 items), and work (4 items). Each item has five response options: never true-1, rarely true-2, sometimes true-3, usually true-4, and always true-5. In computing raw and normalized scores, a pro-rated system is used for handling missing data. Normalized scores are used to obtain scores ranging from 0 (worst QoL) to 100 (best QoL). The Aurea Under the Curve (AUC) of QOL as assessed by IWQOL-Lite questionnaire is reported to combine repeated measurements at flexible time intervals from 0 to 12 months post-procedure into a single numeric value. The higher the AUC value is, the better the patient is.

次要结局

  • Excess Weight Loss (EWL)(12 Months)
  • Health Resource Utilization - Durantion of Sugery(12 Months)
  • Health Resource Utilization - Recovery Time From Surgery(12 months)
  • Health Resource Utilization - Amount of Patients Requiring Transfer to ICU or Other Special Unit During Hospitalization(12 Months)
  • Surgical Complications(30 Days)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (18)

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