Gastric Plication and Banding
GP and Band
Treatment of Morbid Obesity With Gastric Plication and Gastric Banding
1 other identifier
interventional
17
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 24, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedFebruary 20, 2017
February 1, 2017
4.3 years
February 24, 2014
February 16, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Weight loss
The primary endpoint is weight loss two years post-surgery.
Two years
Complications
Intra and post-operative complications will be tracked.
2 years
Study Arms (1)
Band/Plication
EXPERIMENTALTreatment -- band/plication
Interventions
Plication of the stomach will be performed in conjunction with placement of a gastric band.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Related Publications (1)
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.
PMID: 25443058BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bradley J Needleman, MD
Ohio State University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 24, 2014
First Posted
February 26, 2014
Study Start
February 1, 2012
Primary Completion
June 1, 2016
Study Completion
June 1, 2016
Last Updated
February 20, 2017
Record last verified: 2017-02