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临床试验/NCT01105156
NCT01105156Unknown不适用

Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire. The VEW [Vomiting, Eating, and Weight Loss] Questionnaire

North Eastern Weight Loss Surgery1 个研究点 分布在 1 个国家目标入组 361 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
361
试验地点
1
主要终点
Weight Loss

研究概览

简要总结

  1. Background / Scientific Rationale

The VEW (Vomiting, Eating, and Weight Loss) Questionnaire has been developed as a method for the assessment of post bariatric surgery patients, as well as a research tool into the eating behaviour of these patients.

Objective VEW Questionnaire Premise If used optimally the VEW score is a valuable tool for patients who have had Laparoscopic Gastric Band Surgery (LAGB). The VEW score will be able to assist clinicians treating patients with a LAGB, specifically the Swedish Adjustable Gastric Band (SAGB), by providing them a tool to enhance patient outcomes. By using the information gained from the VEW questionnaire we can assess many areas of the eating behavior, and adjustment outcomes in patients with Gastric Bands.

Hypotheses:

  • The VEW questionnaire aids in the assessment of the need for gastric band adjustment (up or down in volume)

  • Comparison of patient factors in those who have had a

  1. good outcome (increased weight loss)
  2. bad outcomes (vomiting, low weight loss, maladaption), from a gastric band fluid addition
  • In patients who have had a bad outcome, which factors are more predictive?

  • Fewer Complications associated with Gastric Band Adjustments

  • Obstruction

  • Need for urgent deflation

  • Pain on eating

  • Lowering incidence of inappropriate fills

  • Lower incidence of maladaption

  • Eating behavior can predict long term outcomes

o By comparison of factors in the different quartiles of weight loss (particularly top 25% cf. bottom 25%)

  • Maintenance of weight loss after 12 months is best achieved by use of behavior modification via improved food tolerances and better eating behavior than by increasing restriction of the band by further adjustments. 12 months is chosen as an arbitrary time where the majority of expected weight loss (45% of expected 50-55% 0f EWL) has been achieved. It is also a time frame by which patients have learnt to use the band appropriately, and the gastric band has had time to be adjusted into its optimal range.

  • The VEW questionnaire can help predict poor outcomes from a SAGB adjustment.

  • By analyzing the factors in patients who have returned both acutely (days) or at subsequent visits (weeks) and had fluid removed from their bands. These factors would include pain, vomiting, length of meals, maladaption score, fluid added, etc.

详细描述

  1. Background / Scientific Rationale

The VEW (Vomiting, Eating, and Weight Loss) Questionnaire has been developed as a method for the assessment of post bariatric surgery patients, as well as a research tool into the eating behaviour of these patients.

Objective VEW Questionnaire Premise If used optimally the VEW score is a valuable tool for patients who have had Laparoscopic Gastric Band Surgery (LAGB). The VEW score will be able to assist clinicians treating patients with a LAGB, specifically the Swedish Adjustable Gastric Band (SAGB), by providing them a tool to enhance patient outcomes. By using the information gained from the VEW questionnaire we can assess many areas of the eating behavior, and adjustment outcomes in patients with Gastric Bands.

Hypotheses:

  • The VEW questionnaire aids in the assessment of the need for gastric band adjustment (up or down in volume)

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
16 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who have received a Swedish Adjustable Gastric gastric band

排除标准

  • Patients who haven't received a Swedish Adjustable Gastric Band

结局指标

主要结局

Weight Loss

时间窗: 1 year

次要结局

  • Vomiting Frequency(12 months)
  • Maladaptive eating(12 months)
  • Gastric Band adjustments(12 months)

研究者

发起方
North Eastern Weight Loss Surgery
申办方类型
Other

研究点 (1)

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