Bariatric Surgery Complications
Conditions
Brief summary
The purpose of this study is to reduce problematic vomiting and associated gastrointestinal symptoms in post-operative LAGB patients. We hypothesize that our behavioral intervention will yield greater reductions in vomiting and associated symptoms compared to our control condition.
Interventions
BEHAVIORALbehavioral intervention
This intervention targets eating behavior to reduce vomiting and associated complications in post-operative LAGB patients.
Sponsors
The Miriam Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 18 and 70 years. 2. Received LAGB surgery with either a standard Lap-Band or a standard Realize Band. 3. Report vomiting at least 3x/week. 4. Agree to allow researchers to communicate with their surgeon regarding their care. 5. Fulfilled all hospital surgery criteria.
Exclusion criteria
1. Report a condition that in the judgment of the Principal Investigator would render them potentially unlikely to follow the protocol (e.g., major illness, plans to move out of the area, substance abuse or other significant psychiatric problems, organic brain disease). 2. Report planning to become pregnant during the time frame of the investigation. 3. Report a history of upper gastrointestinal dismotility.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview | baseline to week 6 |
Secondary
| Measure | Time frame |
|---|---|
| change in gastrointestinal symptom severity - questionnaire measures severity of various GI symptoms over the previous week and items are summed yielding an overall GI severity index | baseline to week 6 |
Countries
United States
Outcome results
None listed