NCT00329862

Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Central Carolina Surgery, PA · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic Truncal Vagotomy

Timeline

• Start date: 2006-05-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2006-05-25
• Last updated: 2011-11-15