Gastric Plication and Banding (GP and Band)

The Ohio State University

Status and phase: Completed; Phase 2

Conditions: Morbid Obesity

Treatments: Procedure: Plication

Study type: Interventional

Funder types: Other

Identifiers

NCT02072395

2012H0003

Details and patient eligibility

About

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.

Enrollment: 17 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Band/Plication

Experimental group

Description:

Treatment -- band/plication

Treatment:

Procedure: Plication