ObesityERAPTNCT04649619
Roux-en-Y Gastric Bypass: Clinical Trial
A study testing GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY in people with Obesity, run by Paulo Reis Esselin de Melo at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obesity
- What is being tested?
- GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 18 Jan 2020to 29 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Paulo Reis Esselin de Melo
Goiânia, Goiás, 74110-010
Paulo Reis Esselin de Melo, +55(62)32099917, prcirurgia@icloud.com
Paulo Reis Esselin de Melo
About this study
Official 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.
Read the detailed 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.
- Conditions
- Obesity
- Being tested
- GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY
- Keywords
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERYProcedure or surgery
Also called ROUX-EN-Y MODIFIED GASTRIC BYPASS
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-arm-study | Other | Prospective clinical trial with intentional sample selection that aims to describe the results of the gastric Bypass surgery modified by De Melo, for the purpose of endoscopic access to the excluded remaining stomach, as well as to monitor the clinical conditions of comorbidities and the quality of life of the patient. Receives: Procedure: GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after surgery
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.
Measured: 6 months after surgery
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.
Measured: 9 months after surgery
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.
Measured: 12 months after surgery
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.
Measured: 18 months after surgery
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.
Measured: 3 months after surgery
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.
Measured: 12 months after surgery
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.
Measured: 18 months after surgery
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.
Measured: 6 months after surgery
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.
Measured: 12 months after surgery
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.
Measured: 18 months after surgery
Secondary outcomes (1)
Weight loss assessment through exams and interviews
Monitoring of weight loss through weighing and questionnaire completed by the patient.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start18 Jan 2020
- Primary completion10 Feb 2021 (estimated)
- Study completion29 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective clinical trial with intentional sample selection that aims to describe the results of the gastric bypass surgery modified by De Melo, for the purpose of endoscopic access to the excluded remaining stomach, as well as to monitor the clinical conditions of comorbidities and the patient's quality of life.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Paulo Reis Esselin de Melo
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Estadual Geral de Goiânia Dr. Alberto Rassi
- Responsible party
- Sponsor-investigator, Paulo Reis Esselin de Melo, Instituto Paulo Reis
- Investigators
- Paulo Reis Esselin de Melo, Principal investigator, Hospital Geral de Goiânia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04649619
- Sponsor's protocol ID
- UTN - U111112498106
- Acronym
- ERAPT
- Status last verified
- Nov 2020
- First submitted
- 7 Aug 2020
- Last updated
- 2 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Roux-en-Y Gastric Bypass as a Therapeutic Option for Patients With Indication for Bariatric and / or Metabolic Surgery: Clinical Trial
- ClinicalTrials.gov ID
- NCT04649619
- Acronym / sponsor ID
- ERAPT / UTN - U111112498106
- Conditions
- Obesity
- Keywords
- Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Paulo Reis Esselin de MeloUniversity, hospital or other
- Collaborators
- Hospital Estadual Geral de Goiânia Dr. Alberto Rassi
- Study start
- 18 Jan 2020 (actual)
- Primary completion
- 10 Feb 2021 (estimated)
- Study completion
- 29 Apr 2021 (estimated)
- First posted
- 2 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective clinical trial with intentional sample selection that aims to describe the results of the gastric bypass surgery modified by De Melo, for the purpose of endoscopic access to the excluded remaining stomach, as well as to monitor the clinical conditions of comorbidities and the patient's quality of life.
| Arm | Type | Receives |
|---|---|---|
| Single-arm-study | Other | Procedure: GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERYProspective clinical trial with intentional sample selection that aims to describe the results of the gastric Bypass surgery modified by De Melo, for the purpose of endoscopic access to the excluded remaining stomach, as well as to monitor the clinical conditions of comorbidities and the quality of life of the patient. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERYAlso: ROUX-EN-Y MODIFIED GASTRIC BYPASSRoux-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. | Procedure or surgery | Single-arm-study |
Primary outcome
Assessment of excess body weight loss
Time frame: 3 months after surgery
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.
Assessment of excess body weight loss
Time frame: 6 months after surgery
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.
Assessment of excess body weight loss
Time frame: 9 months after surgery
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.
Assessment of excess body weight loss
Time frame: 12 months after surgery
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.
Assessment of excess body weight loss
Time frame: 18 months after surgery
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.
Assessment of the remaining stomach and duodenum access by endoscopy exam performed on each patient
Time frame: 3 months after surgery
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.
Assessment of the remaining stomach and duodenum access by endoscopy exam performed on each patient
Time frame: 12 months after surgery
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.
Assessment of the remaining stomach and duodenum access by endoscopy exam performed on each patient
Time frame: 18 months after surgery
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.
Application of the BAROS (Bariatric Analysis and Reporting Outcome) questionnaire
Time frame: 6 months after surgery
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.
Application of the BAROS (Bariatric Analysis and Reporting Outcome) questionnaire
Time frame: 12 months after surgery
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.
Application of the BAROS (Bariatric Analysis and Reporting Outcome) questionnaire
Time frame: 18 months after surgery
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.
1 secondary outcome
Weight loss assessment through exams and interviews
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo Reis Esselin de Melo principal investigator
Hospital Geral de Goiânia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY in people with Obesity, run by Paulo Reis Esselin de Melo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo Reis Esselin de Melo (+55(62)32099917, prcirurgia@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of excess body weight loss (time frame: 3 months after surgery). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2020.