Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

November 14, 2011 updated by: Central Carolina Surgery, PA

Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Excess body weight loss measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
BMI reduction measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
Reduction and or elimination of co-morbidities @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Carolina Surgery, PA

Collaborators

EndoVx, Inc.

Investigators

  • Principal Investigator: Kristen Hardcastle, MD, Central Carolina Surgery, PA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

May 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

May 23, 2006

First Submitted That Met QC Criteria

May 23, 2006

First Posted (Estimate)

May 25, 2006

Study Record Updates

Last Update Posted (Estimate)

November 15, 2011

Last Update Submitted That Met QC Criteria

November 14, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAGBTV

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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