Gastric Plication and Banding

Phase 2CompletedNCT02072395

Ohio State University17 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Morbid Obesity

Interventions

PlicationPROCEDURE

Plication of the stomach will be performed in conjunction with placement of a gastric band.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Weight loss

The primary endpoint is weight loss two years post-surgery.

Time frame: Two years

Complications

Intra and post-operative complications will be tracked.

Time frame: 2 years

Data from ClinicalTrials.gov

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