Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese patients with preoperative GER | Obese patients selected for laparoscopic sleeve gastrectomy with preoperative GER at 24 H pH-monitoring (Group A) | ||
| Obese patients without preoperative GER | Obese patients selected for laparoscopic sleeve gastrectomy without preoperative GER at 24 H pH-monitoring (Group B) |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in lower esophageal sphincter pressure | Esophageal manometry measures several parameters including lower esophageal sphincter pressure | baseline, 24 months after LSG |
| Change from baseline in amplitude of esophageal peristaltic waves |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Consecutive morbidly obese patients selected for LSG
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Fabrizio Rebecchi, MD | University of Turin, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Turin | Turin | Turin | 10126 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23232995 | Background | 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. | |
| 22065341 | Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Esophageal manometry evaluates quality and amplitude of esophageal peristalsis |
| baseline, 24 months after LSG |
| 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 |
| 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 |
| 23460263 | Background | 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. |
| 25379861 | Derived | 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. |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |