Gastric Plication and Banding

Phase 2

Completed

• Conditions: Morbid Obesity

• 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

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-20

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

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.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center; 🇺🇸 Columbus, Ohio, United States