Bariatric Surgery Complications Clinical Trial
| NCT number | NCT01860053 |
| Other study ID # | 2030-09 |
| Secondary ID | |
| Status | Suspended |
| Phase | Phase 2/Phase 3 |
| First received | May 6, 2013 |
| Last updated | May 19, 2013 |
| Start date | May 2009 |
| Verified date | May 2013 |
| Source | The Miriam Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Institutional Review Board |
| Study type | Interventional |
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.
| Status | Suspended |
| Enrollment | 5 |
| Est. completion date | |
| Est. primary completion date | February 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Weight Control and Diabetes Research Center | Providence | Rhode Island |
| Lead Sponsor | Collaborator |
|---|---|
| The Miriam Hospital |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | change in frequency of self-reported vomiting (number of vomiting episodes each week) measured via structured interview | baseline to week 6 | No | |
| Secondary | 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 | No |