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

NCT03692455 | Enrolling By Invitation

• 1 other identifier: PP3 Folow-up
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Gastroesophageal Reflux Disease; Morbid Obesity

Keywords

GERD; Roux-en-Y Gastric Bypass; Vertical Sleeve Gastrectomy; Lion 2.0 Consensus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in number of Participants Presenting GERD symptoms

  8 years after intervention

• Change in number of Participants With Esophageal Injury

  8 years after intervention

• Change in Total Esophageal Acid Exposure at 24h pH Monitoring

  8 years after intervention

• Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position

  8 years after intervention

• Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position

  8 years after intervention

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 78 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

Sponsors & Collaborators

• Clinica Gastrobese: lead
• UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS): collaborator

Study Sites (1)

Gastrobese Clinic

Passo Fundo, Rio Grande do Sul, 99010-112, Brazil

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Richard R Gursky, PhD

  Federal University of Rio Grande do Sul

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director

Study Record Dates

• First Submitted: December 21, 2015
• First Posted: October 2, 2018
• Study Start: September 17, 2025
• Primary Completion: October 17, 2025
• Study Completion: November 8, 2025
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

BR (1)