Clinical trial NCT02012894: Laparoscopic Sleeve Gastrectomy and Gastroesophageal Acid Reflux
Official title: Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroesophageal Reflux
Obesity
Keywords: Obesity
Gastroesophageal reflux
sleeve gastrectomy
pH-monitoring
manometry
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive morbidly obese patients selected for LSG

Brief summary: Symptomatic Gastroesophageal Reflux (GER) is considered by many a contraindication to laparoscopic sleeve gastrectomy (LSG). However, of the few studies that have investigated the relationship between LSG and GER the majority reported only changes in symptoms and manometric data, while assessment of GER using 24-hour pH monitoring is lacking.

The aim of this study is to evaluate the effect of LSG on GER in morbidly obese patients.

Detailed description: Consecutive morbidly obese patients selected for LSG are included in a prospective clinical study. Gastroesophageal function is evaluated using a clinical validated questionnaire, upper endoscopy, esophageal manometry and 24-h pH monitoring before and 24 months after LSG.

Eligibility criteria: Inclusion Criteria:

* history of obesity exceeding 5 years
* documented previous weight loss attempts,
* body mass index (BMI)) of 40-50 kg/m2
* age of 18-60 years.

Exclusion Criteria:

* contraindications to pneumoperitoneum
* large esophageal hiatal hernia
* pregnancy,
* drug or alcohol abuse,
* psychological disorders (e.g., bulimia, depression)
* hormonal or genetic obesity-related disease,
* previous gastric surgery

Primary outcomes:
measure: Change from baseline in DeMeester's score
timeFrame: baseline, 24 months after LSG
Secondary outcomes:
measure: Change from baseline in lower esophageal sphincter pressure
timeFrame: baseline, 24 months after LSG
measure: Change from baseline in amplitude of esophageal peristaltic waves
timeFrame: baseline, 24 months after LSG
measure: Change from baseline in grade of esophagitis
timeFrame: baseline, 24 months after LSG
measure: Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score
timeFrame: Baseline, 24 months after LSG
Other outcomes:
Locations:
city: Turin
country: Italy
facility: University of Turin
Study officials:
affiliation: University of Turin, Italy
name: Fabrizio Rebecchi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tai CM, Huang CK, Lee YC, Chang CY, Lee CT, Lin JT. Increase in gastroesophageal reflux disease symptoms and erosive esophagitis 1 year after laparoscopic sleeve gastrectomy among obese adults. Surg Endosc. 2013 Apr;27(4):1260-6. doi: 10.1007/s00464-012-2593-9. Epub 2012 Dec 12.
citation: Petersen WV, Meile T, Kuper MA, Zdichavsky M, Konigsrainer A, Schneider JH. Functional importance of laparoscopic sleeve gastrectomy for the lower esophageal sphincter in patients with morbid obesity. Obes Surg. 2012 Mar;22(3):360-6. doi: 10.1007/s11695-011-0536-5.
citation: Mahawar KK, Jennings N, Balupuri S, Small PK. Sleeve gastrectomy and gastro-oesophageal reflux disease: a complex relationship. Obes Surg. 2013 Jul;23(7):987-91. doi: 10.1007/s11695-013-0899-x.
citation: Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.