Morbid Obesity
Conditions
Keywords
morbid obesity, bariatric surgery, gastric banding, gastric plication
Brief summary
The purpose of the study is to assess the efficacy of a hybrid laparoscopic surgical procedure for treatment of morbid obesity, Gastric Plication (G)) and Gastric Banding.
Interventions
PROCEDUREPlication
Plication of the stomach will be performed in conjunction with placement of a gastric band.
Sponsors
Ohio State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-70 * BMI \> or = to 30 and co-morbid conditions or BMI \> or = to 40 * Ability to provide informed consent * Willingness to commit to long-term follow-up
Exclusion criteria
* Inability to provide informed consent * Presence of metabolic or medically correctable cause(s) for obesity, such as untreated hypothyroidism or Prader-Willi * Contraindications to surgery such as myocardial infarction within last 6 months, end stage renal or liver disease, current infection, or other disease states contraindicative to surgery, in the principal investigator's opinion * Pregnancy * Plan to become pregnant within two years post-surgery * Current addiction to drugs or alcohol * Previous history of any type of bariatric surgery (de novo group only) * Hiatal hernia \> 3 cm
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | Two years | The primary endpoint is weight loss two years post-surgery. |
| Complications | 2 years | Intra and post-operative complications will be tracked. |
Countries
United States
Outcome results
None listed