---
title: "Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study"
nct_id: NCT03692455
overall_status: ENROLLING_BY_INVITATION
sponsor: Clinica Gastrobese
study_type: OBSERVATIONAL
primary_condition: Gastroesophageal Reflux Disease
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03692455.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03692455"
ct_last_update_post_date: 2025-09-25
last_seen_at: "2026-05-12T07:32:23.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Effect of Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass on Gastroesophageal Reflux Disease: An 8-Year Prospective Cohort Study

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

**NCT ID:** [NCT03692455](https://clinicaltrials.gov/study/NCT03692455)

## Key Facts

- **Status:** ENROLLING_BY_INVITATION
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 75
- **Lead Sponsor:** Clinica Gastrobese
- **Collaborators:** Federal University of Rio Grande do Sul
- **Conditions:** Gastroesophageal Reflux Disease, Morbid Obesity
- **Start Date:** 2025-09-17
- **Completion Date:** 2025-11-08
- **CT.gov Last Update:** 2025-09-25

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 78 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **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.

## Primary Outcomes

- **Change in number of Participants With Gastroesophageal Reflux Disease (GERD)** _(time frame: 8 years after intervention)_ — Prevalence of GERD in patients will be characterized according to Lyon 2.0 consensus

## Secondary Outcomes

- **Change in number of Participants Presenting GERD symptoms** _(time frame: 8 years after intervention)_
- **Change in number of Participants With Esophageal Injury** _(time frame: 8 years after intervention)_
- **Change in Total Esophageal Acid Exposure at 24h pH Monitoring** _(time frame: 8 years after intervention)_
- **Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position** _(time frame: 8 years after intervention)_
- **Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position** _(time frame: 8 years after intervention)_
- **Change in number of Participants With Increased Acid Exposure** _(time frame: 8 years after intervention)_

## Locations (1)

- Gastrobese Clinic, Passo Fundo, Rio Grande do Sul, Brazil

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.gastrobese clinic|passo fundo|rio grande do sul|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03692455.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03692455*  
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