Outcomes of Gastric Band Fills as Found With a Patient Self-reported Questionnaire: The Vomiting, Eating, and Weight Loss (VEW) Questionnaire

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by North Eastern Weight Loss Surgery.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Ethicon Endo-Surgery
Information provided by:
North Eastern Weight Loss Surgery
ClinicalTrials.gov Identifier:
NCT01105156
First received: April 13, 2010
Last updated: April 15, 2010
Last verified: April 2010
  Purpose

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 Intervention
Morbid Obesity
Behavioral: VEW Questionnaire

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by North Eastern Weight Loss Surgery:

Primary Outcome Measures:
  • Weight Loss [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vomiting Frequency [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Maladaptive eating [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Evaluation of any change in dietary habits

  • Gastric Band adjustments [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Number of adjustments


Estimated Enrollment: 361
Study Start Date: April 2010
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gastric Band Patients Behavioral: VEW Questionnaire
Patient Self reported questionnaire filled in.
Other Name: NEWLS Questionnaire

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Patrick Moore, North Eastern Weight Loss Surgery
ClinicalTrials.gov Identifier: NCT01105156     History of Changes
Other Study ID Numbers: NEWLS29401
Study First Received: April 13, 2010
Last Updated: April 15, 2010
Health Authority: Australia: National Health and Medical Research Council

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

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

ClinicalTrials.gov processed this record on July 24, 2014