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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]

NEWLS29401

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Morbid Obesity

Condition category

Condition code

Diet and Nutrition

Obesity

Metabolic and Endocrine

Other metabolic disorders

Oral and Gastrointestinal

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]

BEHAVIORAL

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Weight Loss

Timepoint [1]

1 year

Secondary outcome [1]

Vomiting Frequency

Timepoint [1]

12 months

Secondary outcome [2]

Maladaptive eating

Timepoint [2]

12 months

Secondary outcome [3]

Gastric Band adjustments

Timepoint [3]

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?

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]

North Eastern Weight Loss Surgery - Melbourne

Recruitment postcode(s) [1]

3128 - Melbourne

Funding & Sponsors

Primary sponsor type

Other

Name

North Eastern Weight Loss Surgery

Address

Country

Other collaborator category [1]

Commercial sector/industry

Name [1]

Ethicon Endo-Surgery

Address [1]

Country [1]

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

Patrick M Moore, MBBS FRACS

Address

North Eastern Weight Loss Surgery

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01105156

Trial Review

Registering a new trial?

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01105156