Clinical trial NCT03692455: Clinico-functional Evaluation of GERD: Comparative Study of Vertical Sleeve Gastrectomy vs Roux-en-Y Gastric Bypass
Official title: Clinico-functional Evaluation of Gastroesophageal Reflux Disease (GERD): A Comparative Study Between the Vertical Sleeve Gastrectomy and Roux-en-Y Gastric Bypass Techniques
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastroesophageal Reflux Disease
Morbid Obesity
Keywords: GERD
Roux-en-Y Gastric Bypass
Vertical Sleeve Gastrectomy
Lead sponsor: Clinica Gastrobese
Sponsor class: OTHER
First posted: 2018-10-02
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of this study is that surgical techniques primarily designed for weight loss, ameliorates gastroesophageal reflux disease (GERD) in morbidly obese patients.

Therefore the present study intends to evaluate such impact on patients submitted to two of the most common techniques available, the Roux-en-Y Gastric Bypass and Vertical Sleeve Gastrectomy.

Detailed description: In order to determine if weight loss surgeries do indeed ameliorate GERD in morbidly obese patients, esophageal syndromes will be evaluated following the Montreal 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.

Eligibility criteria: Inclusion Criteria:

* BMI \> 40 Kg/m2, or BMI \> 35 Kg/m2 along with clinical comorbidities (such as Diabetes Mellitus, Systemic Arterial Hypertension or Articular Lesions)
* Been unable to loose or sustain weight loss after 2 years medical and nutritional treatments.

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

Primary outcomes:
measure: Change in number of Participants With Gastroesophageal Reflux Disease (GERD)
timeFrame: Before Intervention, 1 year after intervention
Secondary outcomes:
measure: Change in number of Participants Presenting Reflux Symptoms
timeFrame: Before Intervention, 1 year after Intervention
measure: Change in number of Participants With Esophageal Injury
timeFrame: Before Intervention, 1 year after intervention
measure: Change in Total Esophageal Acid Exposure at 24h pH Monitoring
timeFrame: Before Intervention, 1 year after intervention
measure: Change in Esophageal Acid Exposure at 24h pH Monitoring in Upright Position
timeFrame: Before Intervention, 1 year after intervention
measure: Change in Esophageal Acid Exposure at 24h pH Monitoring in Supine Position
timeFrame: Before Intervention, 1 year after intervention
measure: Change in number of Participants With Increased Acid Exposure
timeFrame: Before Intervention, 1 year after intervention
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Gastrobese Clinic
state: RS
Study officials:
affiliation: Gastrobese Clinic
name: Carlos Augusto S Madalosso, PhD
role: PRINCIPAL_INVESTIGATOR
References: