Status:
SUSPENDED
A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients
Lead Sponsor:
The Miriam Hospital
Conditions:
Bariatric Surgery Complications
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
PHASE3
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...
Eligibility Criteria
Inclusion
- Age between 18 and 70 years.
- Received LAGB surgery with either a standard Lap-Band or a standard Realize Band.
- Report vomiting at least 3x/week.
- Agree to allow researchers to communicate with their surgeon regarding their care.
- Fulfilled all hospital surgery criteria.
Exclusion
- 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).
- Report planning to become pregnant during the time frame of the investigation.
- Report a history of upper gastrointestinal dismotility.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01860053
Start Date
May 1 2009
Last Update
May 22 2013
Active Locations (1)
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1
Weight Control and Diabetes Research Center
Providence, Rhode Island, United States, 02903