Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy - Full Text View

Sponsor:	Central Carolina Surgery, PA
Collaborator:	EndoVx, Inc.
Information provided by:	Central Carolina Surgery, PA
ClinicalTrials.gov Identifier:	NCT00329862

Purpose

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
Morbid Obesity Obstructive Sleep Apnea Hypertension Urinary Incontinence Hypertriglyceridemia Diabetes Hypercholesterolemia	Procedure: Laparoscopic Truncal Vagotomy

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus hypercholesterolemia

MedlinePlus related topics: Cholesterol High Blood Pressure Obesity Sleep Apnea Triglycerides Urinary Incontinence Weight Control Weight Loss Surgery

U.S. FDA Resources

Further study details as provided by Central Carolina Surgery, PA:

Primary Outcome Measures:

Excess body weight loss measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
BMI reduction measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Reduction and or elimination of co-morbidities @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks

Estimated Enrollment:	25
Study Start Date:	May 2006
Study Completion Date:	May 2006
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Male or female patient between 18 to 60 years of age.
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).
Female patients must be willing to use contraceptive methods during the course of the trial (18 months).
Patient must be motivated to lose weight.
Patient has a history of at least one professionally supervised 6 month attempt to lose weight or more than two serious attempts.
Patient must be fully ambulatory.
Patient is to sign and be given a copy of the written informed consent form. -

Exclusion Criteria:

History or signs of prior gastric or esophageal surgery
History of or signs and/or symptoms of gastro-duodenal ulcer disease.
Participation or plans for participation in another investigational study during the study period.
Patients with large hiatal hernias. -

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329862

Sponsors and Collaborators

Central Carolina Surgery, PA

EndoVx, Inc.

Investigators

Principal Investigator:

Kristen Hardcastle, MD

Central Carolina Surgery, PA

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00329862 History of Changes
Other Study ID Numbers:	LAGBTV
Study First Received:	May 23, 2006
Last Updated:	November 14, 2011
Health Authority:	United States: Moses Cone IRB

Keywords provided by Central Carolina Surgery, PA:

Laparoscopic Adjustable Gastric Banding
Truncal Vagotomy
Lap Band
Lap Banding

Obesity Surgery
Bariatric surgery
Weight Loss Surgery

Additional relevant MeSH terms:

Hypercholesterolemia
Hypertension
Hypertriglyceridemia
Urinary Incontinence
Obesity
Obesity, Morbid
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Vascular Diseases
Cardiovascular Diseases
Urination Disorders

Urologic Diseases
Urological Manifestations
Signs and Symptoms
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on February 12, 2012