Language: BG BG
← Back to results
Active (not recruiting) Not applicable NCT07537244

Impact of GEA Simultaneous to VSG on Post-operative GERD

No applicable phase (e.g. observational)
Conditions: Obesity Reflux, Gastroesophageal

Sponsor: Clinica Gastrobese

trial.available_in: БГ
Overview
The goal of this clinical trial is to evaluate the effect of GEA on GERD in patients undergoing VSG. The main question it aims to answer is: • Does adoption of GEA to VSG reduce the occurrence of GERD? Participants will complete a symptom questionnaire during follow-up visits. All exams are already part of the surgical or GERD follow-up routine. Researchers will compare with GEA (Group A) and Without GEA (Group B) to see if adopting GEA during VSG reduces the occurrence of GERD.
Description
All patients aged between 18 and 65 years old who are candidates for bariatric surgery, who opt for VSG, will be consecutively invited to participate in the open study. Initially, patients will be allocated into two groups, matched by BMI and age. Regarding age, they will be separated into two categories: between 18 and 40 years old, ≥40 years old. Regarding BMI, they will be divided into two groups: BMI\<40 and BMI≥40. After being allocated according to weight criteria, the randomization for the GEA will proceed through a draw during the surgical procedure, after making the gastric tube. So, we will have two groups: With GEA (Group A); and Without GEA (Group B), both with 30 patients each, totaling 60 research participants. All patients will be evaluated for GERD before, 12, 24 and 60 months after surgery, and will have permanent access to the team regarding the details of their operations that may be necessary.
Who can participate
Inclusion Criteria: * All VSG candidate patients aged \>18 and \<65 years and BMI≥ 35 and BMI≤50 who agree to participate in the study Exclusion Criteria: * Presence of reflux esophagitis according to the Lyon Consensus * Previous gastric surgery * Esophagus' motor diseases * Development of chronic diseases associated with the use of medications such as chemotherapy, anti-rheumatics, etc. * Patients who fail to undergo the study exams during follow-up or who withdraw the informed consent form (TCLE) at any time during the study
Interventions
gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy
PROCEDURE
vertical sleeve gastrectomy
PROCEDURE
Locations 1
Brazil (1)
Gastrobese Clinic
Passo Fundo , Rio Grande do Sul
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
65 Years
Healthy volunteers
No
Start date
18.02.2023
Completion date
01.04.2028
Registry ID
NCT07537244
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.