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

Morbid Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00285220
• Other study ID #: 00011552
• Status: Completed
• Phase: N/A
• First received: January 31, 2006
• Last updated: February 17, 2009
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: February 2009
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic Truncal Vagotomy

Locations

Country	Name	City	State
United States	Strong Health Bariatric Center at Highland Hospital	Rochester	New York
United States	University of California at San Francisco, Dept of Pediatrics	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Rochester	EndoVx, Inc., University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Excess Weight Loss
Primary	Absolute Weight Loss
Primary	Change in BMI
Primary	Change in Percent Body Fat (DEXA)
Primary	Change in Percent Body Fat (Impedence)
Primary	Change in Lipid Panel (chol, triglycerides, LDL, HDL
Primary	Urinary pH
Primary	3 day dietary diary
Primary	fasting glucose
Primary	OGGT with insulin
Primary	OGGT with FFA and gut peptides
Primary	gastric emptying
Secondary	adverse events