Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study

Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study.

This study represents a long-term observational follow-up of patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).

Study Overview

• Status: Enrolling by invitation
• Conditions: Gastroesophageal Reflux Disease; Morbid Obesity
• Intervention / Treatment: Procedure: Roux-en-Y Gastric Bypass; Procedure: Vertical Sleeve Gastrectomy

Detailed Description

In order to determine the long term impact of Bariatric surgery on GERD, esophageal syndromes will be evaluated following the Lyon 2.0 Consensus, where troublesome symptoms were defined as score ≥ 2 on a validated questionnaire of symptoms for Portuguese language along with esophageal syndromes with injury assessed through upper endoscopy.

Esophageal acid exposure will be determined through 24h pH monitoring. Increased acid exposure will be characterized when total esophageal pH < 4 for at least 4% of its total monitoring time. The data will be collected 8 years after de surgical intervention.

• Study Type: Observational
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Rio Grande do Sul
    • Passo Fundo, Rio Grande do Sul, Brazil, 99010-112
      • Gastrobese Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

This study represents a long-term observational follow-up of 75 patients who had previously undergone bariatric surgery (laparoscopic sleeve gastrectomy or Roux-en-Y gastric bypass) in the context of an earlier interventional trial (NCT03692455). No new interventions are assigned in the follow-up phase. Participants are evaluated clinically and functionally at predefined intervals using standardized multimodal assessments (symptom questionnaires, endoscopy, manometry, radiology, and pH monitoring).

Description

Inclusion Criteria:

Patients enrolled in a previous prospective dual-cohort extension with 75 patients of the original Trial.

Original Inclusion Criteria: Inclusion criteria were age 18-70 years and body mass index (BMI) ≥40 kg/m², or ≥35 kg/m² with obesity-related comorbidities. A total of 75 patients completed the original trial.

Exclusion Criteria: Been previously submitted to any gastroesophageal surgical procedure. Presence of chronical diseases that affects esophageal motility. Do not tolerate any of the required exams

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
LRSYGP Group; Patients will undergo Clinical evaluation and Exams, 8 years after Laparoscopic Roux-Y Gastric Bypass.
LSG group; Patients will undergo Clinical evaluation and Exams 8 years after Laparoscopic Sleeve Gastrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of Participants With Gastroesophageal Reflux Disease (GERD)	Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus	8 years after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of Participants Presenting GERD symptoms	Prevalence of typical reflux syndrome will be evaluated. In order to assess such troublesome symptoms a validated questionnaire translated into Portuguese language will be used.	8 years after intervention
Change in number of Participants With Esophageal Injury	Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis	8 years after intervention
Change in Total Esophageal Acid Exposure at 24h pH Monitoring	Esophageal acid exposure will be measured through 24h pH monitoring. During such period, esophageal pH will be measured and recorded as the percent of time pH stays below 4.	8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position	Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in upright position	8 years after intervention
Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position	Esophageal acid exposure will be measured through 24h pH monitoring. Esophageal pH will be measured and recorded as the percent of time pH stays below 4 while participant in supine position	8 years after intervention
Change in number of Participants With Increased Acid Exposure	Increased Acid Exposure occurs when esophageal pH is <4 for a period longer than 4% of the total test time on a 24h pH monitoring.	8 years after intervention

Collaborators and Investigators

• Sponsor: Clinica Gastrobese
• Collaborators: UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)
• Investigators: Study Chair: Richard R Gursky, PhD, Federal University of Rio Grande do Sul

Study record dates

Study Major Dates

• Study Start (Actual): September 17, 2025
• Primary Completion (Estimated): October 17, 2025
• Study Completion (Estimated): November 8, 2025

Study Registration Dates

• First Submitted: December 21, 2015
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: GERD; Roux-en-Y Gastric Bypass; Vertical Sleeve Gastrectomy; Lion 2.0 Consensus
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Overweight; Obesity; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Morbid; Gastroesophageal Reflux
• Other Study ID Numbers: PP3 Folow-up

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be made publicly available in accordance with the requirements of the journal in which the study will be submitted

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No