Roux-en-Y Gastric Bypass as a Therapeutic Option for Patients With Indication for Bariatric and / or Metabolic Surgery: Clinical Trial

This is a prospective clinical trial with intentional sample selection, which will last 18 months and will be developed at the General State Hospital of Goiânia Alberto Rassi (HGG).

The present study aims at gastric bypass surgery modified for the purpose of ensuring endoscopic access to the excluded remaining stomach, as well as monitoring the clinical conditions of comorbidities and the patient's quality of life; evaluating the loss of excess body weight of 50% (EBW50%), as recommended by the World Health Organization and the Brazilian Society of Bariatric and Metabolic Surgery, to comparing weight loss before and after surgery; comparing the incidence and control of comorbidities associated with excess body weight, if the patient has any, before and after the surgery analyzing the nutritional characteristics of the patients before and after the surgery and its relationship with the obesity of their comorbidities; evaluating and comparing patients' quality of life before and after bariatric surgery;measuring and comparing lung function, respiratory muscle strength and endurance, physical fitness and functional capacity. The estimated sample size was calculated in the Epi Info Software (version 7.2.3.1) considering a 95% Confidence Interval, average volume of bariatric surgeries performed in the last year at HGG (p = 288) and an occurrence of bile reflux after RYGB 1.9%. When considering an estimated margin of error of 5%, the total value of twenty-six patients was found to compose the sample.

Predicting the occurrence of possible losses from follow-up throughout the study, a margin of 30% was added to the calculated value, ending with a total of 33 patients to compose the sample. Free-demand patients at the State Hospital of Goiânia Alberto Rassi, who have an indication for bariatric and / or metabolic surgery confirmed by the medical and multidisciplinary team, will be selected as potential participants in the research. The patient will be invited to participate in the study, receiving complete information about the planned procedures, risks and possible benefits.

The patient's refusal to participate in the research will not result in discontinuation of treatment. The baseline clinical parameters of the selected patients (age, weight, BMI, blood pressure, presented comorbidities, cardiovascular history, previous clinical treatments for the control of DM2 (Type 2 diabetes Mellitus), eating habits and physical activity) will be collected and inserted in clinical records during preoperative multidisciplinary consultation.

Data on food consumption will be collected in the preoperative period and in the postoperative period of 6, 12 and 18 months, through the application of the Food Frequency questionnaire.