Obesity Clinical Trial
— ERAPTOfficial title:
Roux-en-Y Gastric Bypass as a Therapeutic Option for Patients With Indication for Bariatric and / or Metabolic Surgery: Clinical Trial
The present study aims to describe the results of a modified gastric bypass surgery to ensure endoscopic access to the excluded remaining stomach, as well as to monitor the clinical conditions of comorbidities and the patient's quality of life, since associated complications can be found to the excluded stomach, such as: bile reflux, gastritis and / or gastric and duodenal ulcer, H. pylori infection, bleeding, gastric polyps and the possibility of gastric cancer in patients undergoing RYGB (Roux-en-Y gastric bypass), with one of the probable factors being the occurrence reflux of the duodenal content into the excluded portion of the stomach. In this sense, based on technical concepts of an established surgical procedure, the RYGB, the present project is not a proposal for a new procedure, but an adaptation of an existing technique. The proposal of the present study is about adaptations in RYGB surgery, which will enable endoscopic access to the remaining stomach, through the creation of a gastric communication.
Status | Recruiting |
Enrollment | 33 |
Est. completion date | April 29, 2021 |
Est. primary completion date | February 10, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - Individuals of both sexes; - Minimum age of 18 and maximum of 70 years for a BMI greater than or equal to 35 kg / m2; - Age from 30 to 70 years for BMI greater than or equal to 30 and less than or equal to 34.9 kg / m2, associated with diabetes; - Absence of contraindications for the surgical procedure. Exclusion Criteria: - Abandonment of pre-operative multiprofessional follow-up before 12 months; - Members of vulnerable groups; - Uncompensated psychiatric disorders or cognitive impairment confirmed by a psychiatrist and / or psychologist; - Abuse of alcohol or illicit drugs confirmed after evaluation by the psychiatrist and / or psychologist; - Chronic diseases not related to obesity such as cancer, pneumopathy, nephropathy, heart disease, Parkinson's and Alzheimer's. - Patients already undergoing other bariatric surgeries. |
Country | Name | City | State |
---|---|---|---|
Brazil | Paulo Reis Esselin de Melo | Goiânia | Goiás |
Lead Sponsor | Collaborator |
---|---|
Paulo Reis Esselin de Melo | Hospital Estadual Geral de Goiânia Dr. Alberto Rassi |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of excess body weight loss | During postoperative visits, the patient's body weight loss obtained after surgery will be assessed by means of absolute BMI values measured after the operative period and the percentage of lost BMI. | 3 months after surgery | |
Primary | Assessment of excess body weight loss | During postoperative visits, the patient's body weight loss obtained after surgery will be assessed by means of absolute BMI values measured after the operative period and the percentage of lost BMI. | 6 months after surgery | |
Primary | Assessment of excess body weight loss | During postoperative visits, the patient's body weight loss obtained after surgery will be assessed by means of absolute BMI values measured after the operative period and the percentage of lost BMI. | 9 months after surgery | |
Primary | Assessment of excess body weight loss | During postoperative visits, the patient's body weight loss obtained after surgery will be assessed by means of absolute BMI values measured after the operative period and the percentage of lost BMI. | 12 months after surgery | |
Primary | Assessment of excess body weight loss | During postoperative visits, the patient's body weight loss obtained after surgery will be assessed by means of absolute BMI values measured after the operative period and the percentage of lost BMI. | 18 months after surgery | |
Primary | Assessment of the remaining stomach and duodenum access by endoscopy exam performed on each patient | To assess access to the remaining stomach and duodenum, endoscopies will be performed after surgery by a professional from the endoscopy team at Hospital Geral Alberto Rassi. | 3 months after surgery | |
Primary | Assessment of the remaining stomach and duodenum access by endoscopy exam performed on each patient | To assess access to the remaining stomach and duodenum, endoscopies will be performed after surgery by a professional from the endoscopy team at Hospital Geral Alberto Rassi. | 12 months after surgery | |
Primary | Assessment of the remaining stomach and duodenum access by endoscopy exam performed on each patient | To assess access to the remaining stomach and duodenum, endoscopies will be performed after surgery by a professional from the endoscopy team at Hospital Geral Alberto Rassi. | 18 months after surgery | |
Primary | Application of the BAROS (Bariatric Analysis and Reporting Outcome) questionnaire | The questionnaire used for subjective evaluation of the surgery result and the post-operative quality of life adopted will be the BAROS (Bariatric Analysis and Reporting Outcome). The BAROS protocol consists of three major research areas (weight loss, medical conditions and quality of life questionnaire), from which a maximum score of three points is obtained for each category, totaling a maximum of nine points. The questionnaire will be applied by trained researchers. | 6 months after surgery | |
Primary | Application of the BAROS (Bariatric Analysis and Reporting Outcome) questionnaire | The questionnaire used for subjective evaluation of the surgery result and the post-operative quality of life adopted will be the BAROS (Bariatric Analysis and Reporting Outcome). The BAROS protocol consists of three major research areas (weight loss, medical conditions and quality of life questionnaire), from which a maximum score of three points is obtained for each category, totaling a maximum of nine points. The questionnaire will be applied by trained researchers. | 12 months after surgery | |
Primary | Application of the BAROS (Bariatric Analysis and Reporting Outcome) questionnaire | The questionnaire used for subjective evaluation of the surgery result and the post-operative quality of life adopted will be the BAROS (Bariatric Analysis and Reporting Outcome). The BAROS protocol consists of three major research areas (weight loss, medical conditions and quality of life questionnaire), from which a maximum score of three points is obtained for each category, totaling a maximum of nine points. The questionnaire will be applied by trained researchers. | 18 months after surgery | |
Secondary | Weight loss assessment through exams and interviews | Monitoring of weight loss through weighing and questionnaire completed by the patient. | 18 months |
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