Morbid Obesity, Gastroesophageal Reflux, Bariatric Surgery Candidate
Conditions
Keywords
Mini/One anastomosis gastric bypass, Sleeve Gastrectomy, Gastro-esophageal sphincter function
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?
Sponsors
Mario Musella MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modifications in terms of LES function | 12 months | 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) |
| Definition of the best procedure | 12 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Causes of eventual modifications of LES function in relationship with a specific surgical procedure | 6 months and 12 months | 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) |
| Causes of eventual modifications of LES function in relationship with weight loss | 6 months and 12 months | 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. |
Countries
Italy
Contacts
Primary ContactAnnunziata Marfella
Outcome results
None listed