Laparoscopic Roux-en-Y Gastric Bypass and Gastro-esophageal Reflux
NCT ID: NCT02618044
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
86 participants
OBSERVATIONAL
2006-05-31
2015-07-31
Brief Summary
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The aim of this study is to evaluate the long-term effects of laparoscopic Roux-en-Y Gastric Bypass (LRYGB) on gastro-esophageal function.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Obese patients without preoperative GER
Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass without preoperative GER at 24h-impedance pH monitoring (Group G-)
No interventions assigned to this group
Obese patients with preoperative GER
Obese patients selected for laparoscopic Roux-en-Y Gastric Bypass with preoperative GER at 24h-impedance pH monitoring (Group G+)
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* documented previous weight loss attempts,
* body mass index (BMI)) of 40-50 kg/m2
* age of 18-60 years.
Exclusion Criteria
* large esophageal hiatal hernia
* pregnancy,
* drug or alcohol abuse,
* psychological disorders (e.g., bulimia, depression)
* hormonal or genetic obesity-related disease
* previous gastric surgery
18 Years
60 Years
ALL
No
Sponsors
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University of Turin, Italy
OTHER
Responsible Party
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Fabrizio Rebecchi
MD
References
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Vela MF. Non-acid reflux: detection by multichannel intraluminal impedance and pH, clinical significance and management. Am J Gastroenterol. 2009 Feb;104(2):277-80. doi: 10.1038/ajg.2008.23. No abstract available.
Sundbom M, Hedenstrom H, Gustavsson S. Duodenogastric bile reflux after gastric bypass: a cholescintigraphic study. Dig Dis Sci. 2002 Aug;47(8):1891-6. doi: 10.1023/a:1016429603337.
Collard JM, Romagnoli R. Roux-en-Y jejunal loop and bile reflux. Am J Surg. 2000 Apr;179(4):298-303. doi: 10.1016/s0002-9610(00)00326-3.
Mabrut JY, Collard JM, Romagnoli R, Gutschow C, Salizzoni M. Oesophageal and gastric bile exposure after gastroduodenal surgery with Henley's interposition or a Roux-en-Y loop. Br J Surg. 2004 May;91(5):580-5. doi: 10.1002/bjs.4569.
Barak N, Ehrenpreis ED, Harrison JR, Sitrin MD. Gastro-oesophageal reflux disease in obesity: pathophysiological and therapeutic considerations. Obes Rev. 2002 Feb;3(1):9-15. doi: 10.1046/j.1467-789x.2002.00049.x.
Rebecchi F, Allaix ME, Ugliono E, Giaccone C, Toppino M, Morino M. Increased Esophageal Exposure to Weakly Acidic Reflux 5 Years After Laparoscopic Roux-en-Y Gastric Bypass. Ann Surg. 2016 Nov;264(5):871-877. doi: 10.1097/SLA.0000000000001775.
Other Identifiers
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WAROB/97
Identifier Type: -
Identifier Source: org_study_id