Sleeve Versus Bypass in Older Patients: a Randomized Controlled Trial
Condition: Obesity, Morbid; Surgery; Elderly
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      The aim of the study is to compare two different bariatric procedures performed in patients
      with 65 years or more: gastric bypass and sleeve gastrectomy. Primary outcomes will be weight
      loss, control of comorbidities and morbidity of the operation. Secondary outcomes are related
      to functionality, that will be evaluated with specific tests.
    

Detailed description: 
      Introduction: Surgical treatment of obesity in patients over 65 years of age is
      controversial. For patients in this age group, there is a prevailing concept that the risk /
      benefit ratio of the procedure should be evaluated for each individual patient, without
      determining objective criteria or outcomes that characterize this benefit. Increased surgical
      risk in patients older than 65 years is undoubtedly a limiting factor for the broader
      indication of bariatric surgery in this population. The two most applied surgical techniques
      are Sleeve Gastrectomy and Roux-en-Y Gastric Bypass. Most of the studies that evaluated the
      two techniques in elderly patients are retrospective, prospective non-randomized, or
      contemplated only one technique. Recent, studies concluded that in the elderly the weight
      loss with Gastric Bypass was higher, but the surgical morbidity with the Sleeve was lower and
      there was no difference in the resolution of comorbidities between the two techniques. In
      evaluating the benefits of surgery, most studies address outcomes such as weight loss and
      control of metabolic and cardiovascular comorbidities. Outcomes that are specific to the
      treatment of obesity in the elderly, such as improvement of functionality, decreased
      fragility and improvement of the quality of life have not been studied yet. In this field,
      there is concern that excessive weight loss, accompanied by loss of muscle mass may
      compromise the mentioned parameters, especially in individuals who already have loss of bone
      and muscle mass before surgery. For this reason, the assessment of bone mass and body
      composition in the preoperative period of these individuals is fundamental. In order to
      identify the benefits of weight loss promoted by surgery and life expectancy, the elderly
      patients in preparation for operation at the Bariatric Surgery Unit of the Hospital das
      Clinicas University of São Paulo School of Medicine are submitted to a geriatric evaluation,
      which includes the analysis of their functional dependency profile, Important prognostic
      factor in this population. Objectives: The primary objective of the study will be to evaluate
      surgical morbidity and short-term (weight loss, comorbid control) outcomes of surgical
      treatment of obesity in patients over 65 years of age, comparing two techniques: Sleeve
      Gastrectomy (SG) and Gastric Bypass (GB). The secondary objective will be to evaluate the
      body composition of the individuals, before and after the surgery, comparing the two
      techniques. Patients and methods: This is a prospective study, in which 40 consecutive
      patients, aged 65 years and over, will be admitted to the Bariatric and Metabolic Surgery
      Unit of the Discipline of Digestive System Surgery of Hospital das Clinicas University of São
      Paulo School of Medicine with indication criteria for bariatric surgery. Patients will be
      randomized into two groups according to the surgical technique to be used: SG or GB. Data
      related to surgical morbidity, weight loss, control of comorbidities, nutritional
      deficiencies, changes in body composition and functionality will be evaluated and compared
      after a follow-up of at least 12 months.
    

Intervention name(s): Sleeve Gastrectomy; Gastric Bypass
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopic Sleeve Gastrectomy. Technique: complete mobilization of the greater curvature and gastric fundus up to the angle of Hiss; stapling beginning at 3 to 4 cm away from the pylorus; bougie size 32 French; oversuture of the staple line; hiatoplasty in selected cases; routine drainage of the abdominal cavity; Laparoscopic Gastric Bypass. Technique: Pouch size 30 to 40 ml, biliopancreatic limb 70 to 100 cm, alimentary limb 100 to 120 cm, antecolic, routine closure of the mesenterial defects, routine drainage of the abdominal cavity
Other intervention name(s): Vertical gastrectomy; Roux-en_y Gastric Bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: None (Open Label)
Primary purpose: Treatment