Clinical trial

Impact of GEA Simultaneous to VSG on Post-operative GERD

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT07537244

Active, not recruitingNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Reflux, Gastroesophageal

Full registry criteria

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

Treatments and study arms

gastroenteroanastomosis simultaneous to vertical sleeve gastrectomy

Procedure

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.

vertical sleeve gastrectomy

Procedure

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.

Primary outcomes

GERD in endoscopyuntil 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 symptomsuntil 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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Gastrobese Clinic🇧🇷 Passo Fundo, Rio Grande do Sul, Brazil

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