Laparoscopic Sleeve Gastrectomy Plus Weight Watchers vs. Weight Watchers Alone in Underserved Minority Women
Withdrawn before enrolling · Phase 4
Conditions studied: Morbid Obesity
In brief
Obesity is a costly multi-etiology world disease of fat storage. Morbid obesity is defines as greater than 100 pounds overweight and/or greater than 200 % of ideal body weight. Chronic underemployment, poor housing, child abuse, limited education, stress and anxiety are all associated with maternal morbid obesity. These latter conditions leave many patients in a state of economic, social and emotional poverty with need for life-long welfare support. For patients with true morbid obesity a standard surgical procedure is currently the procedure of choice especially among patients who fail standard medical intervention. The major procedures performed for morbid obesity include the Roux-en-Y gastric bypass, sleeve gastrectomy and laparoscopic band procedure. The sleeve gastrectomy is purely a restrictive procedure without malabsorptive components which involves one single staple line and can be performed laparoscopically in less than one hour. While these surgical procedures are recognized as "standard" procedures for patient who have failed medical treatment and are "covered" by most health plans, access to these procedures is limited for the medically underserved, rural, poor or underrepresented minorities since national, state and municipal health plans either provide minimal coverage or no coverage at all for surgery for morbid obesity. Reimbursement to providers offering these procedures is minimal and thus access to bariatric surgery is unlikely within a timely fashion.
Key facts
- Study ID
- NCT01929850
- Run by
- University of California, San Francisco
- People needed
- 0
- Last updated by the study team
- 2015-05-08
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- Subject history of inflammatory disease of the gastrointestinal tract including Crohn's disease or ulcerative colitis
- Significant known esophageal disease including grade 3-4 esophagitis, active gastric ulcer disease or active duodenal ulcer disease
- Severe coagulopathy, upper GI bleeding conditions such as esophageal or gastric varices, congenital or acquired telangiectasia
- Congenital or acquired anomalies of the GI tract such as atresias or stenoses.
- Severe cardiopulmonary disease or other serious organic disease including HIV or cancer
- Currently pregnant or nursing. Potentially childbearing (i.e. not post-menopausal or surgically sterilized) and not willing to use an effective method of contraception for the next 12 months
- Current alcohol or drug addiction
- Mentally retarded or emotionally unstable, or exhibits psychological characteristics which, in the opinion of the investigator or psychologist/psychiatrist, make the subject a poor candidate for this procedure
- Previous gastric, esophageal, pancreatic, or bariatric surgery
- Infection anywhere in the body at the time of the procedure
- Subject history of scleroderma, amyloidosis
- Thyroid disease which is not controlled with medication
- Hormonal or genetic cause for the obese state.
- History of cancer other than localized basal cell carcinoma.
- Myocardial infarction or cerebrovascular accident within past year.
- Angina pectoris.
- Severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000)
- Gastroparesis or pyloric stenosis.
- Lesions with increased risk of bleeding.
- Severe cardiopulmonary disease or other serious organic disease, including HIV or cancer.
- Congestive heart failure.
- Uncontrolled hypertension (systolic > 150 or diastolic > 100).
- Severe or advanced liver disease (such as cirrhosis, chronic hepatitis, portal hypertension, etc.).
- Severe reflux disease.
- Active, continuous alcohol consumption (> 80 gm/day of ethanol) or chronic illicit drug use within the last 3 years.
Where it is running
- UCSF/San Francisco General Hospital — San Francisco, California, United States
Full record on ClinicalTrials.gov
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