Bariatric Surgery Candidate Clinical Trial
Official title:
Efficacy and Safety of Bariatric Surgery for Korean Morbidly Obese Patients : Prospective Multicenter Cohort Study
This trial is a multi-center, single-arm, prospective, observational cohort study of
patients undergoing primary bariatric surgical procedures in Korea. A total of 100 patients
will be recruited over a 1-year period from 2016 to 2017, and will be followed for a mean
follow-up period of 1 year after surgery. The eligible subjects who have given their consent
to participate will undergo one of two surgical procedures; sleeve gastrectomy and Roux-en Y
gastric bypass.
The primary objective of this clinical trial is to measure the changes in body weight (kg)
and waist circumference (cm) of the enrolled patients at postoperative 1 year. Secondary
outcomes are improvement or remission rates of obesity-related co-morbidity (hypertension,
type 2 diabetes, dyslipidemia, and sleep apnea), and the change in quality of life.
Additionally, postoperative incidences of morbidity and mortality, micronutrient status,
body composition, and cost-effectiveness of surgical intervention will be examined.
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