Roux-en-Y Gastric Bypass: Clinical Trial

Obesity Clinical Trial

— ERAPT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04649619
• Other study ID #: UTN - U111112498106
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2020
• Est. completion date: April 29, 2021

Study information

• Verified date: November 2020
• Source: Instituto Paulo Reis
• Contact: Paulo Reis Esselin de Melo
• Phone: +55(62)32099917
• Email: prcirurgia[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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. In addition to collecting this information, the patient will be referred for preoperative exams, which will also be recorded in the patient's medical record. After fulfilling the criteria and after signing the Informed Consent Form, thirty-three patients will be selected who meet the inclusion and exclusion criteria to perform the modified RYGB technique to maintain gastro-gastric communication for endoscopic study after surgery. Patients will undergo a consultation with the multidisciplinary team, when they will receive nutritional, psychological and physiotherapy team guidance. Once the date of the surgery is scheduled, the participants must follow the following regimen: absolute fasting of 8 hours before surgery, prophylactic dose of anticoagulant 12 hours before the surgery. Patients will be admitted 24 to 48 hours before the surgical procedure. The surgery will be performed at the General State Hospital of Goiânia Alberto Rassi. After the preoperative procedure, the patient will be submitted to general anesthesia. Prophylactically, the patient will receive a single dose of 2 to 3 grams of kefazol 1 hour before the procedure, and to allergies 600 to 900 mg of intravenous clindamycin, and pneumatic socks and leggings will be provided to prevent thromboembolic events. For safety reasons, the patient will be monitored throughout the surgical procedure using multiparametric electronic monitors and bladder catheterization. Initially, a median laparotomy will be performed with the measurement of the length of the entire small intestine, followed by an approach to the small curvature of the stomach, where it will be performed.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY
Roux-en-Y gastric bypass: Stapling and reduction of the gastric chamber of approximately 18 cm, followed by anastomosis with a deviated bowel, and another bowel anastomosis with a bowel in a lower portion, for deviation of biliopancreatic secretions. Maintenance of a gastro-gastric communication of approximately 1 cm between the functional gastric pouch and the excluded stomach for endoscopic access.

Locations

Country	Name	City	State
Brazil	Paulo Reis Esselin de Melo	Goiânia	Goiás

Sponsors (2)

Lead Sponsor	Collaborator
Paulo Reis Esselin de Melo	Hospital Estadual Geral de Goiânia Dr. Alberto Rassi

Country where clinical trial is conducted

Brazil, 

Outcome

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