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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
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
NEWLS29401
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
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

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

Gastric Band Patients -


BEHAVIORAL: VEW Questionnaire
Patient Self reported questionnaire filled in.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
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
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Gastric Band adjustments
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
* Patients who have received a Swedish Adjustable Gastric gastric band
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patients who haven't received a Swedish Adjustable Gastric Band

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2010
Actual
Sample size
Target
361
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
North Eastern Weight Loss Surgery - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
North Eastern Weight Loss Surgery
Address
Country
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

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.
Trial website
https://clinicaltrials.gov/study/NCT01105156
Trial related presentations / publications
Public notes

Contacts
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01105156