MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function

Morbid Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02987673
• Other study ID #: MGB1
• Status: Recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2020

Study information

• Verified date: July 2019
• Source: Federico II University
• Contact: Annunziata Marfella
• Phone: 081746
• Email: segreteriamaster2015[@]libero.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Gastroesophageal Reflux
• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• MGB/OAGB

• LSG

Locations

Country	Name	City	State
Italy	Advanced Biomedical Sciences Department - "Federico II" University	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Mario Musella MD

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. E — View 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. d — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modifications in terms of LES function	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? This will be measured by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)	12 months
Primary	Definition of the best procedure	Does one between the two procedures outperform the other one in terms of eventual LES area modifications? This will be measured in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)	12 months
Secondary	Causes of eventual modifications of LES function in relationship with a specific surgical procedure	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? This will be evaluated in both procedures by the numbers and the duration of both acidic and non acidic reflux measured by 24-hour pH-impedance monitoring (MII-pH)	6 months and 12 months
Secondary	Causes of eventual modifications of LES function in relationship with weight loss	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? This will be evaluated in both procedures by the weight loss expressed as body mass index (BMI) points loss.	6 months and 12 months