Bariatric Surgery for Morbid Obesity: Tehran Obesity Treatment Study (TOTS) Rationale and Study Design.

BACKGROUND: Obesity is a major health concern in the Middle East and worldwide. It is among the leading causes of morbidity, mortality, health care utilization, and costs. With bariatric surgery proving to be a more effective treatment option for overweight and obesity, the need for systematic assessment of different procedures and their outcomes becomes necessary. These procedures have not yet been described in detail in our region.

OBJECTIVE: We aim to undertake a prospective study evaluating and comparing several surgical bariatric procedures in an Iranian population of morbid obese patients presenting to a specialized bariatric center.

METHODS: In order to facilitate and accelerate understanding of obesity and its complications, the Tehran Obesity Treatment Study (TOTS) was planned and developed. This study is a longitudinal prospective cohort study in consecutive patients undergoing bariatric surgery. TOTS investigators use standardized definitions, high-fidelity data collection system, and validated instruments to gather data preoperatively, at the time of surgery, postoperatively, and in longer-term follow-up.

RESULTS: This study has recruited 1050 participants as of September 2015 and is ongoing.

CONCLUSIONS: This study will ensure creation of high-level evidence to enable clinicians to make meaningful evidence-based decisions for patient evaluation, selection for surgery, and follow-up care.