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 range18 Years – 60 Years

SexALL

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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. -

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