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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] 0 0
NEWLS29401
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Morbid Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Oral and Gastrointestinal 0 0 0 0
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] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Weight Loss
Timepoint [1] 0 0
1 year
Secondary outcome [1] 0 0
Vomiting Frequency
Timepoint [1] 0 0
12 months
Secondary outcome [2] 0 0
Maladaptive eating
Timepoint [2] 0 0
12 months
Secondary outcome [3] 0 0
Gastric Band adjustments
Timepoint [3] 0 0
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?
No
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] 0 0
North Eastern Weight Loss Surgery - Melbourne
Recruitment postcode(s) [1] 0 0
3128 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
North Eastern Weight Loss Surgery
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Ethicon Endo-Surgery
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Patrick M Moore, MBBS FRACS
Address 0 0
North Eastern Weight Loss Surgery
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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