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

NCT ID: NCT03692455

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-09-17
• Study Completion Date: 2025-11-08

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).

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.

Conditions

Gastroesophageal Reflux Disease; Morbid Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

LRSYGP Group

Patients will undergo Clinical evaluation and Exams, 8 years after Laparoscopic Roux-Y Gastric Bypass.

No interventions assigned to this group

LSG group

Patients will undergo Clinical evaluation and Exams 8 years after Laparoscopic Sleeve Gastrectomy.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 78 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UNIVERSIDADE FEDERAL DO RIO GRANDE DO SUL (UFRGS)

UNKNOWN

Sponsor Role: collaborator

Clinica Gastrobese

OTHER

Sponsor Role: lead

Responsible Party

Carlos AS Madalosso

Clinical Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard R Gursky, PhD

Role: STUDY_CHAIR

Federal University of Rio Grande do Sul

Locations

Gastrobese Clinic

Passo Fundo, Rio Grande do Sul, Brazil

Countries

Brazil

Other Identifiers

PP3 Folow-up

Identifier Type: -

Identifier Source: org_study_id