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Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Primary Purpose

Morbid Obesity, Obstructive Sleep Apnea, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Laparoscopic Truncal Vagotomy
Sponsored by
Central Carolina Surgery, PA
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Morbid Obesity focused on measuring Laparoscopic Adjustable Gastric Banding, Truncal Vagotomy, Lap Band, Lap Banding, Obesity Surgery, Bariatric surgery, Weight Loss Surgery

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female patient between 18 to 60 years of age. 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). Female patients must be willing to use contraceptive methods during the course of the trial (18 months). Patient must be motivated to lose weight. Patient has a history of at least one professionally supervised 6 month attempt to lose weight or more than two serious attempts. Patient must be fully ambulatory. Patient is to sign and be given a copy of the written informed consent form. - Exclusion Criteria: History or signs of prior gastric or esophageal surgery History of or signs and/or symptoms of gastro-duodenal ulcer disease. Participation or plans for participation in another investigational study during the study period. Patients with large hiatal hernias. -

Sites / Locations

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Full Information

    First Posted
    May 23, 2006
    Last Updated
    November 14, 2011
    Sponsor
    Central Carolina Surgery, PA
    Collaborators
    EndoVx, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00329862
    Brief Title
    Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy
    Official Title
    Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Terminated
    Why Stopped
    study size reached
    Study Start Date
    May 2006 (undefined)
    Primary Completion Date
    May 2006 (Actual)
    Study Completion Date
    May 2006 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Central Carolina Surgery, PA
    Collaborators
    EndoVx, Inc.

    4. Oversight

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Morbid Obesity, Obstructive Sleep Apnea, Hypertension, Urinary Incontinence, Hypertriglyceridemia, Diabetes, Hypercholesterolemia
    Keywords
    Laparoscopic Adjustable Gastric Banding, Truncal Vagotomy, Lap Band, Lap Banding, Obesity Surgery, Bariatric surgery, Weight Loss Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    25 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Laparoscopic Truncal Vagotomy
    Primary Outcome Measure Information:
    Title
    Excess body weight loss measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
    Title
    BMI reduction measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks
    Title
    Reduction and or elimination of co-morbidities @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Male or female patient between 18 to 60 years of age. 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). Female patients must be willing to use contraceptive methods during the course of the trial (18 months). Patient must be motivated to lose weight. Patient has a history of at least one professionally supervised 6 month attempt to lose weight or more than two serious attempts. Patient must be fully ambulatory. Patient is to sign and be given a copy of the written informed consent form. - Exclusion Criteria: History or signs of prior gastric or esophageal surgery History of or signs and/or symptoms of gastro-duodenal ulcer disease. Participation or plans for participation in another investigational study during the study period. Patients with large hiatal hernias. -
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kristen Hardcastle, MD
    Organizational Affiliation
    Central Carolina Surgery, PA
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

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