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OpenTrials
Active, Not Recruiting

NCT Number: NCT07537244

Impact of GEA Simultaneous to VSG on Post-operative GERD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Obesity Body Weight Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Reflux, Gastroesophageal Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gastrobese Clinic

Passo Fundo, Rio Grande do Sul, 99020000, Brazil

About this study

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

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: GEA, VSG

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.

Other names: VSG

Primary outcomes

  1. GERD in endoscopy

    Time frame: 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

  2. GERD symptoms

    Time frame: 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 outcomes

  1. weight loss

    Time frame: 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).

Other outcomes

  1. Change in Glycated Hemoglobin (HbA1c) Levels

    Time frame: until 60 months

    significant improvement in metabolic profile for diabetic patients, measured by change in HbA1c levels from baseline to postoperative follow-up.

Sponsors and collaborators

Lead sponsor

Clinica Gastrobese

Other

Registry information

Official study title

Impact of Gastroenteroanastomosis Simultaneous to Vertical Gastrectomy on Post-operative Gastroesophageal Reflux

Important dates

Study start
2023
Primary completion
2024
Study completion
2028
First posted
Apr 17, 2026
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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