Morbid ObesityNCT02987673
MGB/OAGB and LSG Effects on Lower Esophageal Sphincter (LES) Function
A study testing MGB/OAGB and LSG in people with Morbid Obesity and Gastroesophageal Reflux, run by Mario Musella MD at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity, Gastroesophageal Reflux, Bariatric Surgery Candidate
- What is being tested?
- MGB/OAGB and LSG
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).-
Who cannot join
- Patients lost at follow up. Cancer patients at any stage.
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Advanced Biomedical Sciences Department - "Federico II" University
Naples, 80131
Annunziata Marfella, +39081746 ext. 2896
About this study
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
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.
Read more
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?
- Being tested
- MGB/OAGB, LSG
- Keywords
- Mini/One anastomosis gastric bypass, Sleeve Gastrectomy, Gastro-esophageal sphincter function
- Medical subject headings
- Obesity, Morbid, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MGB/OAGBProcedure or surgery
LSGProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mini/One anastomosis gastric bypass | Experimental | Execution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB) Receives: Procedure: MGB/OAGB |
| Laparoscopic sleeve gastrectomy | Active comparator | Execution of a laparoscopic sleeve gastrectomy (LSG) Receives: Procedure: LSG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 12 months
Secondary outcomes (2)
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)
Measured: 6 months and 12 months
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.
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mario Musella MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mario Musella MD, Federico II University
- Investigators
- Mario Musella, MD, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987673
- Sponsor's protocol ID
- MGB1
- Status last verified
- Jul 2019
- First submitted
- 28 Nov 2016
- Last updated
- 1 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24249251Melissas 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.
PubMed 26428250Casella 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.
PubMed 26806727Tolone 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.
PubMed 25979206
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02987673
- Acronym / sponsor ID
- MGB1
- Keywords
- Mini/One anastomosis gastric bypass, Sleeve Gastrectomy, Gastro-esophageal sphincter function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mario Musella MDUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mini/One anastomosis gastric bypass | Experimental | Procedure: MGB/OAGBExecution of a laparoscopic mini/one anastomosis gastric bypass (MGB/OAGB) |
| Laparoscopic sleeve gastrectomy | Active comparator | Procedure: LSGExecution of a laparoscopic sleeve gastrectomy (LSG) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).-
Key exclusion criteria (1 listed)
- Patients lost at follow up. Cancer patients at any stage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MGB/OAGB | Procedure or surgery | Mini/One anastomosis gastric bypass |
| LSG | Procedure or surgery | Laparoscopic sleeve gastrectomy |
Primary outcome
Modifications in terms of LES function
Time frame: 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
Time frame: 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)
2 secondary outcomes
Causes of eventual modifications of LES function in relationship with a specific surgical procedure
Time frame: 6 months and 12 months
Causes of eventual modifications of LES function in relationship with weight loss
Time frame: 6 months and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Results publication: PubMed 24249251Del 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.
- Results publication: PubMed 26428250Melissas 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.
- Results publication: PubMed 26806727Casella 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.
- Results publication: PubMed 25979206Tolone 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario Musella, MD principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MGB/OAGB and LSG in people with Morbid Obesity and Gastroesophageal Reflux, run by Mario Musella MD at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annunziata Marfella (081746 ext. 2896, segreteriamaster2015@libero.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modifications in terms of LES function (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02987673, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2019.