Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
100 participants
INTERVENTIONAL
2013-09-30
2014-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Plication
Prospective clinical trial comparing Standard Adustable Gastric Banding versus experimental Adjustable Gastric Banding
Plication
Prospective clincial trial comparing adjustable gastric banding with plication versus standard adjustable gastric banding. Variables to be studied include patient age, gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data such as operative time and blood loss and post-operative outcomes including length of hosptial stay, complication rates, weight loss, and co-morbid disease resolution.
Interventions
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Plication
Prospective clincial trial comparing adjustable gastric banding with plication versus standard adjustable gastric banding. Variables to be studied include patient age, gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data such as operative time and blood loss and post-operative outcomes including length of hosptial stay, complication rates, weight loss, and co-morbid disease resolution.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Morbidly Obese
* BMI \>40 or
* BMI \>35 plus co-morbid obesity related disease conditions
* Without contraindications to bariatric surgery: eg pregnancy, desire to become pregnant within the next 12 months, myocardial infarct within the last 6 months, cancer within last 5 years, end stage renal/liver disease
* Without any metabolic or medically correctable causes for obesity: eg untreated hypothyroidism, Prader-Willi
* Patients with any major medical problems contraindicating surgery
* Patients with a medically treatable cause of obesity
* Patients who elect to undergo a surgery other than Plication adjustable gastric banding or standard adjustable gastric banding
* Alcohol or drug addiction
* Established infection anywhere in the body at the time of surgery
* Previous history of bariatric surgery, intestinal obstruction, or adhesive peritonitis
* Family or patient history of autoimmune disease
18 Years
ALL
Yes
Sponsors
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Tenet Healthcare Corporation
OTHER
Responsible Party
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Principal Investigators
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James S Scott, MD
Role: PRINCIPAL_INVESTIGATOR
Tenet Healthcare Corporation
Locations
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Des Peres Hospital
St Louis, Missouri, United States
Countries
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Other Identifiers
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2315-1
Identifier Type: -
Identifier Source: org_study_id
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