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Trial details imported from

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Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire: The Vomiting, Eating, and Weight Loss (VEW) Questionnaire
Scientific title
Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire. The VEW [Vomiting, Eating, and Weight Loss] Questionnaire
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 0 0 0 0
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Behaviour - VEW Questionnaire

Gastric Band Patients -

Behaviour: VEW Questionnaire
Patient Self reported questionnaire filled in.

Intervention code [1] 0 0
Comparator / control treatment
Control group

Primary outcome [1] 0 0
Weight Loss
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Vomiting Frequency
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Maladaptive eating - Evaluation of any change in dietary habits
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Gastric Band adjustments - Number of adjustments
Timepoint [3] 0 0
12 months

Key inclusion criteria
- Patients who have received a Swedish Adjustable Gastric gastric band
Minimum age
16 Years
Maximum age
70 Years
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Patients who haven't received a Swedish Adjustable Gastric Band

Study design
Statistical methods / analysis

Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
North Eastern Weight Loss Surgery - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Melbourne

Funding & Sponsors
Primary sponsor type
North Eastern Weight Loss Surgery
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Ethicon Endo-Surgery
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
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

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Patrick M Moore, MBBS FRACS
Address 0 0
North Eastern Weight Loss Surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable