Modified stomach reduction surgery as a treatment option for patients with indication

Roux-en-Y Gastric Bypass as a therapeutic option in patients with indication for Bariatric and / or Metabolic Surgery: clinical trial

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-6j3rqy

Enrollment

Unknown

Registered

2020-09-03

Start date

2019-12-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity due to excess calories. Obesity. Diabetes. Gastric pathologies.

Interventions

This is a prospective clinical trial with intentional selection of a sample of 33 patients, which will last 18 months and will be developed at the General State Hospital of Goiânia Alberto Rassi (HGG)

Procedure/surgery

E02.570.500.062

Eligibility

Age

18 Years to 70 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the possibility of access to the remaining stomach and / or duodenum after bariatric and / or metabolic surgery in order to conduct endoscopic studies when necessary.	—

Secondary

Measure	Time frame
As a secondary outcome, we established the possibility of monitoring the gastric reservoir and the remaining duodenum through an endoscopic study to study the presence of gastritis, ulcers, neoplasms that may be presented by the patient throughout his life.;We also consider weight loss, remission and / or stabilization of other comorbidities associated with obesity and improving the quality of life of patients with a BMI greater than or igaul 35 kg / m2 and with a BMI greater than or equal to 30 kg / m2 diagnosed with diabetes mellitus undergoing metabolic surgery. The results will be widely disseminated through congresses and scientific articles for society and the medical community.	—

Measure

Time frame

As a secondary outcome, we established the possibility of monitoring the gastric reservoir and the remaining duodenum through an endoscopic study to study the presence of gastritis, ulcers, neoplasms that may be presented by the patient throughout his life.;We also consider weight loss, remission and / or stabilization of other comorbidities associated with obesity and improving the quality of life of patients with a BMI greater than or igaul 35 kg / m2 and with a BMI greater than or equal to 30 kg / m2 diagnosed with diabetes mellitus undergoing metabolic surgery. The results will be widely disseminated through congresses and scientific articles for society and the medical community.

—

Countries

Brazil

Contacts

Public ContactPaulo Esselin de Melo

Hospital Geral de Goiânia - HGG

prcirurgia@icloud.com+556232099917

Outcome results

None listed

Source: REBEC (via WHO ICTRP)