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Gastric Plication and Banding (GP and Band)

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ClinicalTrials.gov Identifier: NCT02072395
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : February 20, 2017
Sponsor:
Information provided by (Responsible Party):
Bradley Needleman, 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.

Condition or disease Intervention/treatment Phase
Morbid Obesity Procedure: Plication Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
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 : February 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

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.




Primary Outcome Measures :
  1. Weight loss [ Time Frame: Two years ]
    The primary endpoint is weight loss two years post-surgery.

  2. Complications [ Time Frame: 2 years ]
    Intra and post-operative complications will be tracked.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072395


Locations
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United States, Ohio
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Bradley J Needleman, MD Ohio State University

Publications:
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Responsible Party: Bradley Needleman, Associate Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02072395     History of Changes
Other Study ID Numbers: 2012H0003
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: February 20, 2017
Last Verified: February 2017
Keywords provided by Bradley Needleman, Ohio State University:
morbid obesity
bariatric surgery
gastric banding
gastric plication
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms