GP and Band: Gastric Plication and Banding

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02072395
• Collaborator: (none)
• Enrollment: 17
• Location: 1
• Arm: 1
• Duration (Months): 52
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Morbid Obesity	Procedure: Plication	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 17 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment of Morbid Obesity With Gastric Plication and Gastric Banding
• Study Start Date: Feb 1, 2012
• Actual Primary Completion Date: Jun 1, 2016
• Actual Study Completion Date: Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Band/Plication Treatment -- band/plication	Procedure: Plication; Plication of the stomach will be performed in conjunction with placement of a gastric band.

Outcome Measures

Primary Outcome Measures

1. Weight loss [Two years]

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

2. Complications [2 years]

   Intra and post-operative complications will be tracked.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University Wexner Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Bradley J Needleman, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

• Chaudhry UI, Osayi SN, Suzo AJ, Noria SF, Mikami DJ, Needleman BJ. Laparoscopic adjustable gastric banded plication: case-matched study from a single U.S. center. Surg Obes Relat Dis. 2015 Jan-Feb;11(1):119-24. doi: 10.1016/j.soard.2014.05.030. Epub 2014 Jun 4.

• Responsible Party: Bradley Needleman, Associate Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT02072395
• Other Study ID Numbers: 2012H0003
• First Posted: Feb 26, 2014
• Last Update Posted: Feb 20, 2017
• Last Verified: Feb 1, 2017

• Keywords provided by Bradley Needleman, Associate Professor, Ohio State University: morbid obesity; bariatric surgery; gastric banding; gastric plication
• Additional relevant MeSH terms: Obesity; Obesity, Morbid

Study Results

No Results Posted as of Feb 20, 2017