Active — Not RecruitingNot Applicable

Impact of GEA Simultaneous to VSG on Post-operative GERD

Brazil60 participantsStarted 2023-02-18

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

GERD in endoscopy

Timeframe: until 60 months

GERD symptoms

Timeframe: until 60 months

Trial details

NCT IDNCT07537244

SponsorClinica Gastrobese

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-03-04

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