Morbid ObesityNCT00329862
Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy
A study testing Laparoscopic Truncal Vagotomy in people with Morbid Obesity and Obstructive Sleep Apnea, run by Central Carolina Surgery, PA.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Obstructive Sleep Apnea, Hypertension
- What is being tested?
- Laparoscopic Truncal Vagotomy
- Type of treatment
- Surgery or procedure
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- May 2006to May 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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. -
Who cannot join
- 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. -
About this study
Official title: 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.
Read the 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
- Being tested
- Laparoscopic Truncal Vagotomy
- Keywords
- Laparoscopic Adjustable Gastric Banding, Truncal Vagotomy, Lap Band, Lap Banding, Obesity Surgery, Bariatric surgery, Weight Loss Surgery
- Medical subject headings
- Obesity, Morbid, Sleep Apnea, Obstructive, Hypertension, Urinary Incontinence, Hypertriglyceridemia, Diabetes Mellitus, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Truncal VagotomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2006 (estimated)
- Study startMay 2006
- Primary completionMay 2006
- Study completionMay 2006
Why it stopped: study size reached
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Carolina Surgery, PA
- Sponsor type
- University, hospital or other
- Collaborators
- EndoVx, Inc.
- Investigators
- Kristen Hardcastle, MD, Principal investigator, Central Carolina Surgery, PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00329862
- Sponsor's protocol ID
- LAGBTV
- Status last verified
- Nov 2011
- First submitted
- 23 May 2006
- Last updated
- 15 Nov 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Assessing Advantage of Adding Truncal Vagotomy to LAGB
- ClinicalTrials.gov ID
- NCT00329862
- Acronym / sponsor ID
- LAGBTV
- Conditions
- Morbid Obesity, Obstructive Sleep Apnea, Hypertension, Urinary Incontinence, Hypertriglyceridemia, Diabetes
- Keywords
- Laparoscopic Adjustable Gastric Banding, Truncal Vagotomy, Lap Band, Lap Banding, Obesity Surgery, Bariatric surgery, Weight Loss Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study size reached
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Central Carolina Surgery, PAUniversity, hospital or other
- Collaborators
- EndoVx, Inc.
- Study start
- May 2006
- Primary completion
- May 2006 (actual)
- Study completion
- May 2006 (actual)
- First posted
- 25 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic Truncal Vagotomy | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study was stopped early (reason given: study size reached). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Hardcastle, MD principal investigator
Central Carolina Surgery, PA
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Truncal Vagotomy in people with Morbid Obesity and Obstructive Sleep Apnea, run by Central Carolina Surgery, PA.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: study size reached). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess body weight loss measured @ 6, 12, 18, 24, 30, 36, 42, 48, 54, 60 weeks. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2011.