Impact of GEA Simultaneous to VSG on Post-operative GERD

April 12, 2026 updated by: Carlos AS Madalosso, Clinica Gastrobese

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99020000
        • Gastrobese Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
adoption of GEA to VSG
Procedure: gastroenteroanastomosis 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.
Other Names:
  • VSG
  • GEA
Procedure: vertical 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.
Other Names:
  • VSG
Sham Comparator: Group B
Without GEA to VSG
Procedure: vertical 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.
Other Names:
  • VSG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
until 60 months
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.
until 60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
until 60 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
until 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinica Gastrobese

Investigators

  • Principal Investigator: Carlos Madalosso, PhD, Clinica Gastrobese

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 18, 2023

Primary Completion (Actual)

March 4, 2024

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 12, 2026

First Posted (Actual)

April 17, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 12, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEA+VSG on GERD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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