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Tehran Obesity Treatment Study

Iranian study to examine outcomes from surgery

(Credit: Oren neu dag)
Study will include Iranian researchers are currently evaluating and comparing RYGB, LAGB, LSG, mini-gastric bypass and gastric plication

Iranian researchers are currently evaluating and comparing several surgical bariatric procedures: Roux-en-Y gastric bypass (RYGB), laparoscopic adjustable gastric banding (LAGB), laparoscopic sleeve gastrectomy (LSG) and mini-gastric bypass, with newer techniques such as gastric plication also considered as a treatment option in suitable candidates. The prospective, longitudinal, cohort Tehran Obesity Treatment Study (TOTS) is assessing the impact of these surgical procedures in an Iranian population of morbid obese patients at a specialised bariatric centre. The outline of the study is published in a paper, ‘Bariatric Surgery for Morbid Obesity: Tehran Obesity Treatment Study (TOTS) Rationale and Study Design’, in the journal, JMIR Research Protocols.

The study authors stated that TOTS will create a high-level of evidence that will enable clinicians to make meaningful evidence-based decisions for patient evaluation, selection for surgery, and follow-up care. As of September 2015, the TOTS has recruited 1,050 participants and recruitment is ongoing. The mean age of the participants is 37.8 years, mean BMI43.7 with 76.9% female.

The main objectives of TOTS are to identify perioperative problems of morbidly obese patients; to assess and compare the effectiveness of different bariatric surgical techniques on metabolic syndrome and other obesity-related comorbidity, by measuring anthropometric indices, EWL rates, glucose homeostasis, blood pressure, lipid profile, hormone levels, and nutritional status; to assess the psychosocial aspects of obesity before and after the bariatric surgery, and long term, including quality of life and depression; and to explore the mechanisms and underlying pathophysiology in the field of obesity and its comorbidities through pathological, genetic, and molecular studies.

All patients enrolled in TOTS undergo a bariatric procedure based on an individualised clinical decision plan that is organised into four phases: pre-operative evaluation, operation, short-term follow-up and long-term follow-up.

The inclusion criteria are 15-65 years old, BMI levels ≥40 or 30<BMI<35 with a medical comorbidity/failure of intensive medical treatment for at least one year, acceptable surgical risk and able and willing to provide informed consent and assure regular follow-up. Exclusion criteria include any other medical, psychological, or social condition which, in the opinion of the investigators, would interfere with safe completion of the study protocol; high operative risk; contraindication to bariatric surgery or weight loss; active drug addiction; nursing, pregnant, or intending to become pregnant in the following year; and unable or unwilling to complete questionnaires or expected to experience difficulty with attendance of visits or completion of study.

Preoperative evaluation

The baseline data includes demographic data, anthropometric indices, physical examination, quality of life score, psychological data, and physical activity levels. All patients are referred for several assessments including cardiac and respiratory (including ECG, echocardiogram, chest x-ray, pulmonary function test, and/or polysomnography), gastrointestinal (endoscopy and/or barium meal and abdominal ultrasound), endocrine, and psychological assessments. Each individual’s data in then assessed by an obesity expert physician.

Detailed data regarding anaesthesiology, operation (the surgical procedures are broken down into of its components eg, length of alimentary limb, pouch size), and recovery are collected after each procedure. In addition, post-operative follow-up for complications of surgery as well as other issues are recorded. All participants are scheduled for follow-up visits by a multidisciplinary team (ie, surgeon, obesity specialist, endocrinologist, and dietitian) at ten days, and at one, three, six, and 12 months, and annually thereafter. In the case of mortality, data will be collected based on the death certificate. Data regarding anthropometric indices and physical examination are collected at one month and three months after surgery. At the next visit, six months postoperatively, a more detailed assessment, including blood samples, is performed. Patients then are followed annually and re-assessed on all baseline variables.

Endpoints

In order to evaluate the effectiveness of bariatric surgery on obesity and obesity-related comorbidities, all participants are interviewed by a trained physician to complete a standardized clinical history questionnaire. It covers risk factors for cardiovascular disease, hypertension, hyperlipidaemia, diabetes, and familial history of non-communicable diseases, smoking habits, drug abuse, and alcohol consumption. A similar postoperative survey is completed as well. The physicians are required to undergo periodic evaluation according to written protocols and control procedures to ensure up-to-date and universal practice.

In order to document the frequency of complications after these most common techniques, as well as newer techniques in this study, the dataset is designed to describe early (occurring within 30 days of surgery) and long-term complications and factors associated with those events.

“There is still no universal agreement to recommend one procedure over another,” the authors write. “Choice of the procedure depends on many factors such as the available expertise, risk stratification, patient preferences, and goal of therapy (weight loss vs glycaemic control)…This is one of the very first studies of its kind in the Middle East and addresses the knowledge gap on the effectiveness, safety, and efficacy of bariatric surgical techniques, including LSG, mini-bypass, and gastric plication.

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