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

NCT02987673 | Unknown

• 1 other identifier: MGB1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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?

Conditions

Morbid Obesity; Gastroesophageal Reflux; Bariatric Surgery Candidate

Keywords

Mini/One anastomosis gastric bypass; Sleeve Gastrectomy; Gastro-esophageal sphincter function

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Causes of eventual modifications of LES function in relationship with a specific surgical procedure

  6 months and 12 months

• Causes of eventual modifications of LES function in relationship with weight loss

  6 months and 12 months

Study Arms (2)

Mini/One anastomosis gastric bypass

EXPERIMENTAL

Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB)

Procedure: MGB/OAGB

Laparoscopic sleeve gastrectomy

ACTIVE COMPARATOR

Execution of a laparoscopic sleeve gastrectomy (LSG)

Procedure: LSG

Interventions

MGB/OAGB PROCEDURE

Mini/One anastomosis gastric bypass

LSG PROCEDURE

Laparoscopic sleeve gastrectomy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).-

You may not qualify if:

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

Sponsors & Collaborators

• Mario Musella MD: lead

Study Sites (1)

Advanced Biomedical Sciences Department - "Federico II" University

Naples, 80131, Italy

RECRUITING

Related Publications (4)

• 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.

  PMID: 24249251 RESULT

• 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.

  PMID: 26428250 RESULT

• 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.

  PMID: 26806727 RESULT

• 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.

  PMID: 25979206 RESULT

MeSH Terms

Conditions

Obesity, Morbid; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Mario Musella, MD

  Federico II University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annunziata Marfella

CONTACT

081746; segreteriamaster2015@libero.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 9, 2016
• Study Start: January 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2020
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)