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Gastric Plication and Banding (GP and Band)

Primary Purpose

Morbid Obesity

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Plication
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring morbid obesity, bariatric surgery, gastric banding, gastric plication

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The Ohio State University Wexner Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Band/Plication

Arm Description

Treatment -- band/plication

Outcomes

Primary Outcome Measures

Weight loss
The primary endpoint is weight loss two years post-surgery.
Complications
Intra and post-operative complications will be tracked.

Secondary Outcome Measures

Full Information

First Posted
February 24, 2014
Last Updated
February 16, 2017
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT02072395
Brief Title
Gastric Plication and Banding
Acronym
GP and Band
Official Title
Treatment of Morbid Obesity With Gastric Plication and Gastric Banding
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity
Keywords
morbid obesity, bariatric surgery, gastric banding, gastric plication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Band/Plication
Arm Type
Experimental
Arm Description
Treatment -- band/plication
Intervention Type
Procedure
Intervention Name(s)
Plication
Intervention Description
Plication of the stomach will be performed in conjunction with placement of a gastric band.
Primary Outcome Measure Information:
Title
Weight loss
Description
The primary endpoint is weight loss two years post-surgery.
Time Frame
Two years
Title
Complications
Description
Intra and post-operative complications will be tracked.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bradley J Needleman, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25443058
Citation
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.
Results Reference
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Gastric Plication and Banding

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