Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00329862
Recruitment Status : Terminated (study size reached)
First Posted : May 25, 2006
Last Update Posted : November 15, 2011
EndoVx, Inc.
Information provided by:
Central Carolina Surgery, PA

Brief Summary:
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 or disease Intervention/treatment Phase
Morbid Obesity Obstructive Sleep Apnea Hypertension Urinary Incontinence Hypertriglyceridemia Diabetes Hypercholesterolemia Procedure: Laparoscopic Truncal Vagotomy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB
Study Start Date : May 2006
Actual Primary Completion Date : May 2006
Actual Study Completion Date : May 2006

Primary Outcome Measures :
  1. Excess body weight loss measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
  2. BMI reduction measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
  3. Reduction and or elimination of co-morbidities @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00329862

Sponsors and Collaborators
Central Carolina Surgery, PA
EndoVx, Inc.
Principal Investigator: Kristen Hardcastle, MD Central Carolina Surgery, PA Identifier: NCT00329862     History of Changes
Other Study ID Numbers: LAGBTV
First Posted: May 25, 2006    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011

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:
Sleep Apnea, Obstructive
Urinary Incontinence
Obesity, Morbid
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Lipid Metabolism Disorders
Metabolic Diseases
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Nutrition Disorders