NCT01105156

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
  • good outcome (increased weight loss)
  • 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 Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
361

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
Last Updated

April 16, 2010

Status Verified

April 1, 2010

Enrollment Period

Same day

First QC Date

April 13, 2010

Last Update Submit

April 15, 2010

Conditions

Morbid Obesity

Keywords

Gastric bandQuestionnairePost operative managementAdjustment

Outcome Measures

Primary Outcomes (1)

  • Weight Loss

    1 year

Secondary Outcomes (3)

  • Vomiting Frequency

    12 months

  • Maladaptive eating

    12 months

  • Gastric Band adjustments

    12 months

Study Arms (1)

Gastric Band Patients

Behavioral: VEW Questionnaire

Interventions

VEW QuestionnaireBEHAVIORAL

Patient Self reported questionnaire filled in.

Also known as: NEWLS Questionnaire
Gastric Band Patients

Eligibility Criteria

Age16 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients who have received a Swedish Adjustable Gastric band at North Eastern Weight Loss Surgery

You may qualify if:

  • Patients who have received a Swedish Adjustable Gastric gastric band

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

North Eastern Weight Loss Surgery

Melbourne, Victoria, 3128, Australia

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Patrick M Moore, MBBS FRACS

    North Eastern Weight Loss Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2010

First Posted

April 16, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 16, 2010

Record last verified: 2010-04

Locations

AU(1)