Gastric Plication and Banding
Phase 2
Completed
- Conditions
- Morbid Obesity
- Interventions
- Procedure: Plication
- Registration Number
- NCT02072395
- Lead Sponsor
- Ohio State University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 17
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Band/Plication Plication Treatment -- band/plication
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States