MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function
NCT ID: NCT02987673
Last Updated: 2019-08-01
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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UNKNOWN
NA
80 participants
INTERVENTIONAL
2016-01-31
2020-12-31
Brief Summary
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Setting "Federico II" University Hospital, Naples - ITALY.
Methods Fifty morbid obese patients are going to be studied. All patients presenting with a normal preoperative LES function will be randomly assigned to undergo LSG (arm 1 - 25 pts) or MGB (arm 2 - 25 pts). Patients undergo clinical assessment for reflux symptoms, and esophago-gastro-duodenoscopy (EGDS) plus high-resolution impedance manometry (HRiM) and 24-hour pH-impedance monitoring (MII-pH) before, two months and 1 year after both LSG or MGB/OAGB.
Objective Endpoint 1: Does this surgery affect the LES area function in both arm 1 or arm 2 patients determining a possible increase in gastroesophageal acid or non acid reflux? Endpoint 2: Does one between the two procedures outperform the other one in terms of eventual LES area modifications? Endpoint 3: In the case of a good performance of LSG or MGB/OAGB or both the procedures, is this to be primarily related to surgery per se or to weight loss?
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Mini/One anastomosis gastric bypass
Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB)
MGB/OAGB
Laparoscopic sleeve gastrectomy
Execution of a laparoscopic sleeve gastrectomy (LSG)
LSG
Interventions
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MGB/OAGB
LSG
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
65 Years
ALL
No
Sponsors
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Mario Musella MD
OTHER
Responsible Party
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Mario Musella MD
Associate Professor of Surgery
Principal Investigators
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Mario Musella, MD
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
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Advanced Biomedical Sciences Department - "Federico II" University
Naples, , Italy
Countries
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Central Contacts
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Facility Contacts
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Annunziata Marfella
Role: primary
References
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Del Genio G, Tolone S, Limongelli P, Brusciano L, D'Alessandro A, Docimo G, Rossetti G, Silecchia G, Iannelli A, del Genio A, del Genio F, Docimo L. Sleeve gastrectomy and development of "de novo" gastroesophageal reflux. Obes Surg. 2014 Jan;24(1):71-7. doi: 10.1007/s11695-013-1046-4.
Melissas J, Braghetto I, Molina JC, Silecchia G, Iossa A, Iannelli A, Foletto M. Gastroesophageal Reflux Disease and Sleeve Gastrectomy. Obes Surg. 2015 Dec;25(12):2430-5. doi: 10.1007/s11695-015-1906-1.
Casella G, Soricelli E, Giannotti D, Collalti M, Maselli R, Genco A, Redler A, Basso N. Long-term results after laparoscopic sleeve gastrectomy in a large monocentric series. Surg Obes Relat Dis. 2016 May;12(4):757-762. doi: 10.1016/j.soard.2015.09.028. Epub 2015 Oct 1.
Tolone S, Cristiano S, Savarino E, Lucido FS, Fico DI, Docimo L. Effects of omega-loop bypass on esophagogastric junction function. Surg Obes Relat Dis. 2016 Jan;12(1):62-9. doi: 10.1016/j.soard.2015.03.011. Epub 2015 Mar 27.
Other Identifiers
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MGB1
Identifier Type: -
Identifier Source: org_study_id
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