Obesity Clinical Trial
Official title:
Physiopathologic Evaluation of Esophageal Function After Laparoscopic Sleeve Gastrectomy
Verified date | December 2013 |
Source | University of Turin, Italy |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Observational |
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.
Status | Completed |
Enrollment | 65 |
Est. completion date | September 2013 |
Est. primary completion date | September 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 60 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Italy | University of Turin | Turin |
Lead Sponsor | Collaborator |
---|---|
University of Turin, Italy |
Italy,
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. Review. — View Citation
Petersen WV, Meile T, Küper MA, Zdichavsky M, Königsrainer 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. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in DeMeester's score | Use of the composite score that evaluates GER at 24-h pH monitoring before and 24 months after LSG. It includes numbers of reflux episodes, upright time in reflux, recumbent time in reflux, total time in reflux, reflux episodes over 5 minutes, longest reflux episodes | baseline, 24 months after LSG | No |
Secondary | Change from baseline in lower esophageal sphincter pressure | Esophageal manometry measures several parameters including lower esophageal sphincter pressure | baseline, 24 months after LSG | No |
Secondary | Change from baseline in amplitude of esophageal peristaltic waves | Esophageal manometry evaluates quality and amplitude of esophageal peristalsis | baseline, 24 months after LSG | No |
Secondary | Change from baseline in grade of esophagitis | Upper endoscopy is performed to assess preoperative and postoperative presence and severity of esophagitis | baseline, 24 months after LSG | No |
Secondary | Change from baseline in Gastroesophageal reflux disease Symptom Assessment Scale score | Standard and validated questionnaire is used to assess gastroesophageal symptoms and quality of life | Baseline, 24 months after LSG | No |
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