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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01105156
Registration number
NCT01105156
Ethics application status
Date submitted
13/04/2010
Date registered
16/04/2010
Date last updated
16/04/2010
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
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Scientific title
Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire. The VEW [Vomiting, Eating, and Weight Loss] Questionnaire
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Secondary ID [1]
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NEWLS29401
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Oral and Gastrointestinal
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
BEHAVIORAL - VEW Questionnaire
Gastric Band Patients -
BEHAVIORAL: VEW Questionnaire
Patient Self reported questionnaire filled in.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Weight Loss
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Assessment method [1]
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Timepoint [1]
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1 year
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Secondary outcome [1]
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Vomiting Frequency
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Assessment method [1]
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Timepoint [1]
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12 months
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Secondary outcome [2]
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Maladaptive eating
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Assessment method [2]
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Evaluation of any change in dietary habits
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Gastric Band adjustments
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Assessment method [3]
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Number of adjustments
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Timepoint [3]
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12 months
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Eligibility
Key inclusion criteria
* Patients who have received a Swedish Adjustable Gastric gastric band
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Minimum age
16
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients who haven't received a Swedish Adjustable Gastric Band
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2010
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Actual
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Sample size
Target
361
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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North Eastern Weight Loss Surgery - Melbourne
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Recruitment postcode(s) [1]
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3128 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
North Eastern Weight Loss Surgery
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Ethicon Endo-Surgery
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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. 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.
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Trial website
https://clinicaltrials.gov/study/NCT01105156
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Patrick M Moore, MBBS FRACS
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Address
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North Eastern Weight Loss Surgery
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT01105156
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