TerminatedNot Applicable

Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Stopped: study size reached

25 participantsStarted 2006-05

Plain-language 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.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. -

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT00329862

SponsorCentral Carolina Surgery, PA

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2006-05

View on ClinicalTrials.gov More Morbid Obesity trials

Plain-language summary

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. -

Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Laparoscopic Adjustable Gastric Banding With Truncal Vagotomy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria