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

Not Applicable

• Conditions: Gastroesophageal Reflux Disease; Morbid Obesity

• Registration Number: NCT03692455
• Lead Sponsor: Clinica Gastrobese

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.

Study Timeline

• Study First Submitted: 2015-12-21
• Study First Submitted QC: 2018-09-28
• Study First Posted: 2018-10-02
• Status Verified: 2025-09
• Study Start: 2025-09-17
• Last Update Submitted: 2025-09-22
• Last Update Posted: 2025-09-25
• Primary Completion: 2025-10-17
• Study Completion: 2025-11-08

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in number of Participants Presenting GERD symptoms	8 years after intervention	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.
Change in number of Participants With Esophageal Injury	8 years after intervention	Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis
Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position	8 years after intervention	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
Change in Total Esophageal Acid Exposure at 24h pH Monitoring	8 years after intervention	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.
Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position	8 years after intervention	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
Change in number of Participants With Increased Acid Exposure	8 years after intervention	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.

Trial Locations

Locations (1)

Gastrobese Clinic; 🇧🇷 Passo Fundo, Rio Grande do Sul, Brazil