Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire: The Vomiting, Eating, and Weight Loss (VEW) Questionnaire
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|ClinicalTrials.gov Identifier: NCT01105156|
Recruitment Status : Unknown
Verified April 2010 by North Eastern Weight Loss Surgery.
Recruitment status was: Not yet recruiting
First Posted : April 16, 2010
Last Update Posted : April 16, 2010
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.
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
- good outcome (increased weight loss)
- 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
- 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.
|Condition or disease||Intervention/treatment|
|Morbid Obesity||Behavioral: VEW Questionnaire|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||361 participants|
|Official Title:||Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire. The VEW [Vomiting, Eating, and Weight Loss] Questionnaire|
|Study Start Date :||April 2010|
|Estimated Primary Completion Date :||April 2010|
|Estimated Study Completion Date :||April 2010|
|Gastric Band Patients||
Behavioral: VEW Questionnaire
Patient Self reported questionnaire filled in.
Other Name: NEWLS Questionnaire
- Weight Loss [ Time Frame: 1 year ]
- Vomiting Frequency [ Time Frame: 12 months ]
- Maladaptive eating [ Time Frame: 12 months ]Evaluation of any change in dietary habits
- Gastric Band adjustments [ Time Frame: 12 months ]Number of adjustments
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01105156
|North Eastern Weight Loss Surgery||Active, not recruiting|
|Melbourne, Victoria, Australia, 3128|
|Principal Investigator:||Patrick M Moore, MBBS FRACS||North Eastern Weight Loss Surgery|