Clinical trial NCT02987673: MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function
Official title: Effects of Mini/One Anastomosis Gastric Bypass (MGB/OAGB) and Sleeve Gastrectomy (LSG) on Lower Esophageal Sphincter (LES) Function. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Morbid Obesity
Gastroesophageal Reflux
Bariatric Surgery Candidate
Keywords: Mini/One anastomosis gastric bypass
Sleeve Gastrectomy
Gastro-esophageal sphincter function
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2016-12-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background While several articles have reported about the effects of laparoscopic sleeve gastrectomy (LSG) on the lower esophageal sphincter (LES), to date, just one paper has discussed this issue with regard the Mini/One anastomosis gastric bypass (MGB/OAGB). This is expected to be the first randomized trial exploring and comparing these two interventions.

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?


Eligibility criteria: Inclusion Criteria:

* 80 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 - 40 pts) or MGB (arm 2 - 40 pts).-

Exclusion Criteria:

* Patients lost at follow up. Cancer patients at any stage.

Primary outcomes:
measure: Modifications in terms of LES function
timeFrame: 12 months
measure: Definition of the best procedure
timeFrame: 12 months
Secondary outcomes:
measure: Causes of eventual modifications of LES function in relationship with a specific surgical procedure
timeFrame: 6 months and 12 months
measure: Causes of eventual modifications of LES function in relationship with weight loss
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Advanced Biomedical Sciences Department - "Federico II" University
Study officials:
affiliation: Federico II University
name: Mario Musella, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.