Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy
NCT ID: NCT03705416
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
250 participants
OBSERVATIONAL
2019-03-30
2028-03-30
Brief Summary
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Detailed Description
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Presently, bariatric procedures are the only sustainable method to address morbid obesity and its resulting comorbidities. There are endoscopic and surgical bariatric procedures. The natural history of GERD symptoms in this population after undergoing a bariatric treatment is scarce or conflicting. Moreover, silent or asymptomatic GERD prevalence has not been well established preoperatively. Evaluation and documentation of GERD may potentially change the planned bariatric procedure and avoid unnecessary additional surgeries or procedures to address symptomatic post-operative GERD.
The investigators hypothesized that GERD is more prevalent in patients undergoing surgical bariatric procedures, specifically laparoscopic vertical sleeve gastrectomy (VSG). This multi-center, prospective, cohort study can potentially clarify current debatable data, based mostly on retrospective studies, and can help clinicians to select the most appropriate bariatric treatment for the patients. Most importantly, by selecting the best approach based on preoperative GERD studies it could prevent long term complications of GERD and further unnecessary procedures for the bariatric patient.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Endoscopic sleeve gastroplasty
All obese patients who will be undergoing an endoscopic sleeve gastroplasty (ESG). As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the endoscopic sleeve gastroplasty patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed
Endoscopy
endoscopic suturing of stomach
Surgery (VSG or RYGBP)
All obese patients who will be undergoing either a vertical sleeve gastrectomy or a Roux-en-Y gastric bypass. As part of the standard of care this patients will have a preoperative gastroscopy with wireless pH monitoring. Then after the surgical procedure patients will be followed up regarding GERD symptoms for 5 years. As part of the standard of care a follow up endoscopy will be done at year 1 and wireless pH monitoring will be performed
Surgery
Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure
Interventions
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Endoscopy
endoscopic suturing of stomach
Surgery
Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients scheduled to undergo a bariatric weight loss procedure (endoscopic or surgical)
* Patients older than 18 years and younger than 75 years of age at time of consent
* Patients able to provide written informed consent on the Institutional review board (IRB) approved informed consent form
* Patients willing and able to comply with study requirements for follow-up
Exclusion Criteria
* Patients treated with intragastric balloons.
* Pre-existing esophageal stenosis/stricture preventing advancement of an endoscope during screening/baseline Esophagogastroduodenoscopy (EGD)
* Esophageal, gastric or duodenal malignancy
* Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist
* Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication (ASA, Plavix) for 1 week prior to and 2 weeks after each endoscopy
* Active fungal esophagitis
* Known portal hypertension, visible esophageal or gastric varices, or history of esophageal varices
* General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation
* Pregnant or planning to become pregnant during period of study participation
* Patient refuses or is unable to provide written informed consent
* Prior bariatric treatment procedure
* Prior surgical or endoscopic anti-reflux procedure
18 Years
75 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Responsible Party
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Principal Investigators
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Marcia I Canto, MD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Northwell Health
New Hyde Park, New York, United States
Weill Cornell
New York, New York, United States
Legacy Oregon Clinic
Portland, Oregon, United States
Memorial Hermann Health System
Houston, Texas, United States
Utah-Health: University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Vakil N, van Zanten SV, Kahrilas P, Dent J, Jones R; Global Consensus Group. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006 Aug;101(8):1900-20; quiz 1943. doi: 10.1111/j.1572-0241.2006.00630.x.
Tutuian R. Obesity and GERD: pathophysiology and effect of bariatric surgery. Curr Gastroenterol Rep. 2011 Jun;13(3):205-12. doi: 10.1007/s11894-011-0191-y.
Singh M, Lee J, Gupta N, Gaddam S, Smith BK, Wani SB, Sullivan DK, Rastogi A, Bansal A, Donnelly JE, Sharma P. Weight loss can lead to resolution of gastroesophageal reflux disease symptoms: a prospective intervention trial. Obesity (Silver Spring). 2013 Feb;21(2):284-90. doi: 10.1002/oby.20279.
Borbely Y, Schaffner E, Zimmermann L, Huguenin M, Plitzko G, Nett P, Kroll D. De novo gastroesophageal reflux disease after sleeve gastrectomy: role of preoperative silent reflux. Surg Endosc. 2019 Mar;33(3):789-793. doi: 10.1007/s00464-018-6344-4. Epub 2018 Jul 12.
El-Serag HB, Graham DY, Satia JA, Rabeneck L. Obesity is an independent risk factor for GERD symptoms and erosive esophagitis. Am J Gastroenterol. 2005 Jun;100(6):1243-50. doi: 10.1111/j.1572-0241.2005.41703.x.
Kurian M, Kroh M, Chand B, Mikami D, Reavis K, Khaitan L. SAGES review of endoscopic and minimally invasive bariatric interventions: a review of endoscopic and non-surgical bariatric interventions. Surg Endosc. 2018 Oct;32(10):4063-4067. doi: 10.1007/s00464-018-6238-5. Epub 2018 May 29.
Chung AY, Thompson R, Overby DW, Duke MC, Farrell TM. Sleeve Gastrectomy: Surgical Tips. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):930-937. doi: 10.1089/lap.2018.0392. Epub 2018 Jul 13.
Schlottmann F, Buxhoeveden R. Laparoscopic Roux-en-Y Gastric Bypass: Surgical Technique and Tips for Success. J Laparoendosc Adv Surg Tech A. 2018 Aug;28(8):938-943. doi: 10.1089/lap.2018.0393. Epub 2018 Jul 16.
Rebecchi F, Allaix ME, Giaccone C, Ugliono E, Scozzari G, Morino M. Gastroesophageal reflux disease and laparoscopic sleeve gastrectomy: a physiopathologic evaluation. Ann Surg. 2014 Nov;260(5):909-14; discussion 914-5. doi: 10.1097/SLA.0000000000000967.
Burgerhart JS, Schotborgh CA, Schoon EJ, Smulders JF, van de Meeberg PC, Siersema PD, Smout AJ. Effect of sleeve gastrectomy on gastroesophageal reflux. Obes Surg. 2014 Sep;24(9):1436-41. doi: 10.1007/s11695-014-1222-1.
Oor JE, Roks DJ, Unlu C, Hazebroek EJ. Laparoscopic sleeve gastrectomy and gastroesophageal reflux disease: a systematic review and meta-analysis. Am J Surg. 2016 Jan;211(1):250-67. doi: 10.1016/j.amjsurg.2015.05.031. Epub 2015 Aug 14.
Other Identifiers
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The ROSE study
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00186052
Identifier Type: -
Identifier Source: org_study_id