A Behavioral Intervention to Decrease Vomiting and Improve Weight Loss in Post-Operative Laparoscopic Adjustable Gastric Banding (LAGB) Patients

Lifespan

Status and phase: Suspended; Phase 3; Phase 2

Conditions: Bariatric Surgery Complications

Treatments: Behavioral: behavioral intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01860053

2030-09

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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5 participants in 2 patient groups

behavioral intervention

Experimental group

Treatment:

Behavioral: behavioral intervention

no treatment control

No Intervention group