Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

A Prospective, Multi-Center Study to Evaluate the Safety and Effectiveness of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

This two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity
• Intervention / Treatment: Procedure: Laparoscopic Truncal Vagotomy

Detailed Description

30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of >35 with at least one obesity related comorbidity or a BMI between 40 and 45. Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline.

Thereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.

• Study Type: Interventional
• Enrollment: 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California at San Francisco, Dept of Pediatrics
  • New York
    • Rochester, New York, United States, 14624
      • Strong Health Bariatric Center at Highland Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• male or female age 25-55
• BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity
• Stable weight for the last 3 months
• willing to use contraceptives
• motivated to lose weight
• a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight
• fully ambulatory

Exclusion Criteria:

• sign of prior major abdominal surgery
• history of or signs and /or symptoms of gastro-duodenal ulcer disease
• abnormal vagus nerve testing
• current use of a list of medication

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
fasting glucose
Percent Excess Weight Loss
Absolute Weight Loss
Change in BMI
Change in Percent Body Fat (DEXA)
Change in Percent Body Fat (Impedence)
Change in Lipid Panel (chol, triglycerides, LDL, HDL
Urinary pH
3 day dietary diary
OGGT with insulin
OGGT with FFA and gut peptides
gastric emptying

Secondary Outcome Measures

Outcome Measure
adverse events

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: University of California, San Francisco; EndoVx, Inc.
• Investigators: Principal Investigator: Marco Pattti, MD, University of California, San Francisco; Principal Investigator: Thad Boss, MD, University of Rochester

Study record dates

Study Major Dates

• Study Start: September 1, 2005
• Study Completion (Actual): December 1, 2008

Study Registration Dates

• First Submitted: January 31, 2006
• First Submitted That Met QC Criteria: January 31, 2006
• First Posted (Estimate): February 1, 2006

Study Record Updates

• Last Update Posted (Estimate): February 19, 2009
• Last Update Submitted That Met QC Criteria: February 17, 2009
• Last Verified: February 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: 00011552