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Sponsors and Collaborators: |
Central Carolina Surgery, PA EndoVx, Inc. |
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Information provided by: | Central Carolina Surgery, PA |
ClinicalTrials.gov Identifier: | NCT00329862 |
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.
Condition | Intervention |
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Morbid Obesity Obstructive Sleep Apnea Hypertension Urinary Incontinence Hypertriglyceridemia Diabetes Hypercholesterolemia |
Procedure: Laparoscopic Truncal Vagotomy |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB |
Estimated Enrollment: | 25 |
Study Start Date: | May 2006 |
Estimated Study Completion Date: | May 2006 |
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.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kristen Hardcastle, MD | 336-387-8126 | hardcastlek@bellsouth.net |
Contact: Mary Ellen Workman, BSN, MA | 336.387.8133 | mworkman2@centralcarolinasurgery.com |
United States, North Carolina | |
Wesley Long Community Hopital | Recruiting |
Greensboro, North Carolina, United States, 27410 | |
Contact: Kristen Hardcastle, MD 336-286-0468 hardcastlek@bellsouth.net | |
Contact: Kristen Hardcastle, MD 336-286-0468 hardcastlek@bellsouth.net |
Principal Investigator: | Kristen Hardcastle, MD | Central Carolina Surgery, PA |
Study ID Numbers: | LAGBTV |
Study First Received: | May 23, 2006 |
Last Updated: | May 23, 2006 |
ClinicalTrials.gov Identifier: | NCT00329862 History of Changes |
Health Authority: | United States: Moses Cone IRB |
Laparoscopic Adjustable Gastric Banding Truncal Vagotomy |
Sleep Apnea, Obstructive Sleep Disorders Overweight Sleep Disorders, Intrinsic Body Weight Signs and Symptoms Urologic Diseases Respiratory Tract Diseases Nutrition Disorders Metabolic Disorder Hypercholesterolemia Dyslipidemias Imidacloprid Obesity Sleep Apnea Syndromes |
Metabolic Diseases Hyperlipidemias Hypertriglyceridemia Apnea Urination Disorders Respiration Disorders Diabetes Mellitus Vascular Diseases Dyssomnias Obesity, Morbid Urinary Incontinence Overnutrition Hypertension Lipid Metabolism Disorders |
Sleep Apnea, Obstructive Sleep Disorders Overweight Sleep Disorders, Intrinsic Body Weight Signs and Symptoms Urologic Diseases Respiratory Tract Diseases Nutrition Disorders Cardiovascular Diseases Hypercholesterolemia Dyslipidemias Obesity Sleep Apnea Syndromes Metabolic Diseases |
Hyperlipidemias Hypertriglyceridemia Urination Disorders Apnea Nervous System Diseases Respiration Disorders Vascular Diseases Dyssomnias Obesity, Morbid Urological Manifestations Urinary Incontinence Overnutrition Lipid Metabolism Disorders Hypertension |