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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

NCT01105156 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 361

Last updated 2010-04-16

No results posted yet for this study

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.

Conditions

  • Morbid Obesity

Interventions

BEHAVIORAL

VEW Questionnaire

Patient Self reported questionnaire filled in.

Sponsors & Collaborators

  • Ethicon Endo-Surgery

    collaborator INDUSTRY

  • North Eastern Weight Loss Surgery

    lead OTHER

Principal Investigators

  • Patrick M Moore, MBBS FRACS · North Eastern Weight Loss Surgery

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-04-30
Completion
2010-04-30

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01105156 on ClinicalTrials.gov