NCT04649619

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 18, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 2, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2021

Completed
Last Updated

December 2, 2020

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

August 7, 2020

Last Update Submit

November 25, 2020

Conditions

Obesity

Keywords

Obesity

Outcome Measures

Primary Outcomes (11)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (1)

  • Weight loss assessment through exams and interviews

    18 months

Study Arms (1)

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.

Procedure: GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY

Interventions

GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERYPROCEDURE

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.

Also known as: ROUX-EN-Y MODIFIED GASTRIC BYPASS
Single-arm-study

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Paulo Reis Esselin de Melo

Goiânia, Goiás, 74110-010, Brazil

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Anastomosis, Roux-en-YBariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical ProceduresBariatricsObesity ManagementTherapeutics

Study Officials

  • Paulo Reis Esselin de Melo

    Hospital Geral de Goiânia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paulo Reis Esselin de Melo

CONTACT

+55(62)32099917prcirurgia@icloud.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 7, 2020

First Posted

December 2, 2020

Study Start

January 18, 2020

Primary Completion

February 10, 2021

Study Completion

April 29, 2021

Last Updated

December 2, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)