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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
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
North Eastern Weight Loss Surgery

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.

Condition or disease Intervention/treatment
Morbid Obesity Behavioral: VEW Questionnaire

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 361 participants
Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Gastric Band Patients Behavioral: VEW Questionnaire
Patient Self reported questionnaire filled in.
Other Name: NEWLS Questionnaire



Primary Outcome Measures :
  1. Weight Loss [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Vomiting Frequency [ Time Frame: 12 months ]
  2. Maladaptive eating [ Time Frame: 12 months ]
    Evaluation of any change in dietary habits

  3. Gastric Band adjustments [ Time Frame: 12 months ]
    Number of adjustments



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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients who have received a Swedish Adjustable Gastric band at North Eastern Weight Loss Surgery
Criteria

Inclusion Criteria:

  • Patients who have received a Swedish Adjustable Gastric gastric band

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Locations
Australia, Victoria
North Eastern Weight Loss Surgery Active, not recruiting
Melbourne, Victoria, Australia, 3128
Sponsors and Collaborators
North Eastern Weight Loss Surgery
Ethicon Endo-Surgery
Investigators
Principal Investigator: Patrick M Moore, MBBS FRACS North Eastern Weight Loss Surgery

Responsible Party: Patrick Moore, North Eastern Weight Loss Surgery
ClinicalTrials.gov Identifier: NCT01105156     History of Changes
Other Study ID Numbers: NEWLS29401
First Posted: April 16, 2010    Key Record Dates
Last Update Posted: April 16, 2010
Last Verified: April 2010

Keywords provided by North Eastern Weight Loss Surgery:
Gastric band
Questionnaire
Post operative management
Adjustment

Additional relevant MeSH terms:
Weight Loss
Vomiting
Obesity, Morbid
Body Weight Changes
Body Weight
Signs and Symptoms
Signs and Symptoms, Digestive
Obesity
Overnutrition
Nutrition Disorders
Overweight