Obesity, Reflux, Gastroesophageal
Conditions
Keywords
Gastroesophageal reflux disease, vertical sleeve gastrectomy, gastroenteroanastomosis
Brief summary
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.
Detailed 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.
Interventions
PROCEDUREgastroenteroanastomosis simultaneous to vertical sleeve gastrectomy
GEA will be held after completion of GV. The small intestine is then measured every 5 cm, measured with the aid of markings on the laparoscopic clamps, and at 280 cm the manual laterolateral gastroileal anastomosis is performed between 4 and 5 cm in an isoperistaltic direction and 3 cm proximally to the pylorus. Then, 40 cm distally to the gastroileoanastomosis, the Roux-en-Y is constructed with a 2-cm diameter lateral-to-side manual anastomosis followed by the transection of the ileal limb segment interposed with the anastomoses.
PROCEDUREvertical sleeve gastrectomy
VSG will be performed as primary surgery. The greater curvature is released up to the angle of His in order to perform an ascending stapling from 5 cm proximal to the pylorus to 1 cm from the angle of His and guided by a 32 French Fouchet probe. Stapling starts 5 cm from the pylorus and extends to 1 cm from the angle of His. The result is a tube of approximately 150 ml as adapted in consensus.
Sponsors
Clinica Gastrobese
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GERD in endoscopy | until 60 months | decrease or absence of esophagitis, detected by endoscopy (Los Angeles classification), and esophageal acid exposure, detected by pH monitoring, in the group with GEA |
| GERD symptoms | until 60 months | improvement or absence of GERD symptoms reported by the patient in consultation and QS-GERD. The QS-GERD (Gastroesophageal Reflux Disease Symptom Questionnaire) is a self-administered tool designed to diagnose and quantify the intensity of GERD symptoms. It consists of approximately 11 questions (including self-perceived health), assessing typical and atypical symptoms, with scores ranging from 0 to 50 or 55, indicating the severity of reflux. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| weight loss | until 60 months | Better weight loss with the combination of techniques during the postoperative period, measured through body mass index (BMI), bioelectrical impedance analysis (fat mass/lean mass), body weight, and percent excess BMI loss (% excess BMI loss). |
Countries
Brazil
Contacts
PRINCIPAL_INVESTIGATORCarlos Madalosso, PhD
Clinica Gastrobese
Outcome results
None listed