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NCT Number: NCT03692455

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).

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Key information

Conditions

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

Age range

18 year–78 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gastrobese Clinic

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Change in number of Participants Presenting GERD symptoms

    Time frame: 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.

  2. Change in number of Participants With Esophageal Injury

    Time frame: 8 years after intervention

    Syndromes with esophageal injury should be determined exclusively by the presence of reflux esophagitis

  3. Change in Total Esophageal Acid Exposure at 24h pH Monitoring

    Time frame: 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.

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

    Time frame: 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

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

    Time frame: 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

  6. Change in number of Participants With Increased Acid Exposure

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clinica Gastrobese

Other

Collaborators

  • Federal University of Rio Grande do Sul

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 2, 2018
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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