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

Clinica Gastrobese

Status: Invitation-only

Conditions: Gastroesophageal Reflux Disease; Morbid Obesity

Treatments: Procedure: Vertical Sleeve Gastrectomy; Procedure: Roux-en-Y Gastric Bypass

Study type: Observational

Funder types: Other

Identifiers

NCT03692455

PP3 Folow-up

Details and patient eligibility

About

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).

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 78 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

75 participants in 2 patient groups

LRSYGP Group

Description:

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

LSG group

Description:

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