View Clinical Trial (Medical Research Study)
Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy - NCT00329862-27410(Clinical Trial 143607)
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| City: |
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Greensboro |
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State:
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NC |
| Zip Code: |
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27410 |
| Conditions: |
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Morbid Obesity - Obstructive Sleep Apnea - Hypertension - Urinary Incontinence - Hypertriglyceridemia - Diabetes - Hypercholesterolemia |
| Purpose: |
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Laparoscopic Adjustable Gastric Banding (LAGB) is a gold standard in the surgical treatment
of morbid obesity. We hypothesize that the addition of truncal vagotomy (cutting of nerves
to the stomach) will produce greater weight loss and better reduction of co-morbidities
(diseases caused by or aggravated by morbid obesity) than LAGB alone. 25 patients will be
enrolled and outcomes compared to LAGB historical controls over a post-operative period of
24 months.
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| Study summary: |
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The patients will receive standard laparoscopic adjustable gastric banding treatment as
well as truncal vagotomy. The vagus nerves will be cut just below the diaphragm using the
same access ports that are used during the laparoscopic adjustable gastric banding. During
the surgical procedure, the first fifteen patients will also receive a dose of Baclofen, a
vagus nerve stimulant, and an endoscopy at the end of the procedure during which congo red
dye will sprayed within the stomach. The Baclofen and endoscopy are used to ensure that all
branches of the vagus nerve have been cut. If, after 15 complete vagotomies, are verified by
the above testing then the use of Baclofen and endoscopy will be abandoned. |
| Criteria: |
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Inclusion Criteria:
1. Male or female patient between 18 to 60 years of age.
2. Patient has body mass index (BMI) between 40 to 50 or a BMI between 35 to 40 with
one or more co-morbidities , and a stable weight for the last 3 months (+ 3 kg).
3. Female patients must be willing to use contraceptive methods during the course of the
trial (18 months).
4. Patient must be motivated to lose weight.
5. Patient has a history of at least one professionally supervised 6 month attempt to
lose weight or more than two serious attempts.
6. Patient must be fully ambulatory.
7. Patient is to sign and be given a copy of the written informed consent form. -
Exclusion Criteria:
1. History or signs of prior gastric or esophageal surgery
2. History of or signs and/or symptoms of gastro-duodenal ulcer disease.
3. Participation or plans for participation in another investigational study during the
study period.
4. Patients with large hiatal hernias. - |
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| Study is available at: |
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Wesley Long Community Hopital
Greensboro, NC 27410
United States
Primary Contact:
Kristen Hardcastle, MD
Email: hardcastlek@bellsouth.net
Phone: 336-286-0468
Secondary Contact:
Kristen Hardcastle, MD
Email: hardcastlek@bellsouth.net
Phone: 336-387-8126 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
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