Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study (ReBvSS)
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ClinicalTrials.gov Identifier: NCT04763993 |
Recruitment Status :
Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : March 22, 2023
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Tracking Information | |||||||||
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First Submitted Date ICMJE | February 10, 2021 | ||||||||
First Posted Date ICMJE | February 21, 2021 | ||||||||
Last Update Posted Date | March 22, 2023 | ||||||||
Estimated Study Start Date ICMJE | May 1, 2024 | ||||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Change of the pre-existing Gastro-Esophageal Reflux Disease (GERD) from baseline in patients underwent SG and RYGBP [ Time Frame: Change from baseline DeMeester Score 24 months after surgery ] GERD will be evaluated performing 24-h pH monitoring before the surgery. The presence and the degree of GERD will be quantified calculating the DeMeester Score (DMS):
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Study | ||||||||
Official Title ICMJE | Reflux Disease After Gastric Bypass Versus Sleeve Gastrectomy in Morbid Obese Patients: an Italian Monocentric Randomized Clinical Study (ReBvSS) | ||||||||
Brief Summary | The study aims to clarify if GERD, defined by results of 24 hours potential of hydrogen (pH) monitoring and abnormal DeMeester Score (DMS), in obese patients could worsen after Sleeve Gastrectomy (SG) more than after RYGBP. To demonstrate this hypothesis, the investigators will study the obese population suspected for GERD with 24 hours monitoring and High-Resolution Esophageal Manometry (HRM). DMS is calculated pre-operatively and, once GERD is confirmed, the patients are enrolled for randomization to SG or RYGBP. The suspicion of GERD is investigated with the GERDQ score and EGDS, that all obese patients have pre-operatory. | ||||||||
Detailed Description | Obesity is an independent risk factor for GERD and its complications. Bariatric surgery is effective in treatment of obesity and at the same time in controlling GERD, but there is disparity in current literature if sleeve gastrectomy could worsen it, more than gastric bypass. Our study aims to investigate if there is a difference in postoperative GERD between these two surgical procedures in obese patients with pre-existing GERD, defined by results of 24 hours pH monitoring, expressed by an abnormal DeMeester Score (DMS). REBvSS is a monocentric randomized controlled trial (RCT). The investigators will study 128 obese patients, eligible for Bariatric Surgery (BMS), suspected for GERD, with 24-h pH monitoring and high-resolution manometry. DMS is calculated pre-operatively and, once GERD is confirmed, the patients are randomized to SG or RYGBP. The DMS is then calculated on 24 hours pH monitoring 24 months after the surgery and the degree of GERD is evaluated. The promoter centre is the Division of Minimally invasive Oncological General Surgery at Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda, Milan, Lombardy, that is an excellence centre for bariatric and metabolic surgery according to Società Italiana di Chirurgia dell'Obesità e delle malattie metaboliche (SICOB) accreditation policy, where the study will be carried out. Medical history will be collected during the first outpatient examination and assessed as follows:
The postoperative visits will be organised as follow:
Every patient will be analysed according to the allocated treatment. The investigators hope that our study will finally answer this issue, thanks to its randomized nature and the definition of GERD based on gold standard pH monitoring. These findings might influence decision-making in bariatric surgery and change or confirm the success of sleeve gastrectomy, also for what concerns the reflux disease. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
128 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | May 1, 2025 | ||||||||
Estimated Primary Completion Date | May 1, 2024 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Not Provided | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT04763993 | ||||||||
Other Study ID Numbers ICMJE | ReBvSS | ||||||||
Has Data Monitoring Committee | No | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Niguarda Hospital | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | Niguarda Hospital | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE | Not Provided | ||||||||
PRS Account | Niguarda Hospital | ||||||||
Verification Date | March 2023 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |