Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Hypertension Clinical Trial

Official title:

Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00329862
• Other study ID #: LAGBTV
• Status: Terminated
• Phase: N/A
• First received: May 23, 2006
• Last updated: November 14, 2011
• Start date: May 2006
• Est. completion date: May 2006

Study information

• Verified date: November 2011
• Source: Central Carolina Surgery, PA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Moses Cone IRB
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: May 2006
• Est. primary completion date: May 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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. -

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes
• Hypercholesterolemia
• Hypertension
• Hypertriglyceridemia
• Morbid Obesity
• Obesity, Morbid
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive
• Urinary Incontinence

Intervention

Procedure:
• Laparoscopic Truncal Vagotomy

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Central Carolina Surgery, PA	EndoVx, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess body weight loss measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Primary	BMI reduction measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Primary	Reduction and or elimination of co-morbidities @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks