NCT07537244

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
23mo left

Started Feb 2023

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Feb 2023Apr 2028

Study Start

First participant enrolled

February 18, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2024

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

April 17, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Expected
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1 year

First QC Date

March 31, 2023

Last Update Submit

April 12, 2026

Conditions

ObesityReflux, Gastroesophageal

Keywords

Gastroesophageal reflux diseasevertical sleeve gastrectomygastroenteroanastomosis

Outcome Measures

Primary Outcomes (2)

  • GERD in endoscopy

    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

    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 Outcomes (1)

  • weight loss

    until 60 months

Other Outcomes (1)

  • Change in Glycated Hemoglobin (HbA1c) Levels

    until 60 months

Study Arms (2)

Group A

EXPERIMENTAL

adoption of GEA to VSG

Procedure: gastroenteroanastomosis simultaneous to vertical sleeve gastrectomyProcedure: vertical sleeve gastrectomy

Group B

SHAM COMPARATOR

Without GEA to VSG

Procedure: vertical sleeve gastrectomy

Interventions

gastroenteroanastomosis simultaneous to vertical sleeve gastrectomyPROCEDURE

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.

Also known as: GEA, VSG
Group A
vertical sleeve gastrectomyPROCEDURE

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.

Also known as: VSG
Group AGroup B

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All VSG candidate patients aged \>18 and \<65 years and BMI≥ 35 and BMI≤50 who agree to participate in the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gastrobese Clinic

Passo Fundo, Rio Grande do Sul, 99020000, Brazil

Location

MeSH Terms

Conditions

ObesityGastroesophageal Reflux

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Carlos Madalosso, PhD

    Clinica Gastrobese

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

March 31, 2023

First Posted

April 17, 2026

Study Start

February 18, 2023

Primary Completion

March 4, 2024

Study Completion (Estimated)

April 1, 2028

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

BR(1)