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| ID | Type | Description | Link |
|---|---|---|---|
| The ROSE study | Other Identifier | Johns Hopkins University |
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GERD is common in the obese population. Bariatric procedures are the mainstay of therapy for these patients. Bariatric procedures can be surgical (Roux-en-Y gastric bypass and Vertical sleeve gastrectomy) or endoscopic (endoscopic sleeve gastroplasty). The rate of GERD after either treatment is unknown as is the rate of silent reflux. The study primary objective is to assess the incidence rate of GERD in bariatric patients that undergo either therapy.
GERD is a prevalent condition worldwide, estimated to be around 20-30 % in North America. Obesity is rapidly increasing with an estimated prevalence of 66% in the adult population in the United States. GERD symptoms are common in the obese population with data showing weekly GERD symptoms in 34.6% and erosive esophagitis 26.9% in people with BMI > 30 Kg/m2.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopy | Procedure | endoscopic suturing of stomach |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with GERD based on symptoms, and abnormal acid exposure time and/or reflux esophagitis | GERD symptoms, esophageal acid exposure time and/or esophagitis | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in BMI after the bariatric procedure | change in weight in Kg and height in m (BMI=Kg/m) before and after treatment | 5 years |
| Reflux esophagitis | Incidence of GERD-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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Obese patients with BMI 30 scheduled to undergo a bariatric interventions (endoscopic and surgical) at multiple academic medical centers in the United States offering both treatments.
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| Name | Affiliation | Role |
|---|---|---|
| Marcia I Canto, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States | ||
| Northwell Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16928254 | Background | 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. | |
| 21424733 | Background |
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Research projects will be submitted to host (currently JHU) and accepted project will be granted access to read only de-identified database.
available in 6 years
Project submission to PI and or Heartburn Registry management team then if project accepted, security clearance and enrollment in REDCap and tutorial completions.
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| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| Surgery | Procedure | Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure |
|
|
| 5 years |
| GERD severity based on standardized Reflux Disease Questionnaire (RDQ) | GERD severity based on standardized Reflux Disease Questionnaire (RDQ) questionnaire (score 12-72; the greater the score, the greater the severity) | 3,6,12,24,26,48, and 60 months post procedure |
| GERD severity as assessed by GERD-Health related quality of life (HRQL) score | GERD-Health related quality of life (HRQL) score (score 0-53; the greater the score,the worse the quality of life) will be used for this assessment | 3,6,12,24,26,48, and 60 months post procedure |
| Percentage of participants on daily or twice daily PPI for GERD symptoms control, regardless of pH-monitoring results | Proportion of patients being treated with medication (PPI) | 5 years |
| Percent of patients with abnormal esophageal acid exposure time > 6% defined by Bravo pH monitoring (96 hours) | Abnormal esophageal acid exposure time (AET) | 1 year |
| Percentage of excess body weight (EBW) loss and total body weight loss (TBWL) | Change in body weight after treatment with endoscopy and surgery (compare groups) | 5 years |
| Prevalence and incidence of silent reflux | Proportion of patients with abnormal AET without symptoms after bariatric treatment procedure | 1 year |
| Percentage of patients with GERD at baseline in whom the planned bariatric intervention was changed due to abnormal ph testing or presence of erosive esophagitis, Barrett's esophagus, reflux related esophageal stricture | Proportion of patients with change in treatment plan after diagnostic evaluation | 1 year |
| New Hyde Park |
| New York |
| 11040 |
| United States |
| Weill Cornell | New York | New York | 10021 | United States |
| Legacy Oregon Clinic | Portland | Oregon | 97213 | United States |
| Memorial Hermann Health System | Houston | Texas | 77401 | United States |
| Utah-Health: University of Utah | Salt Lake City | Utah | 84132 | United States |
| 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. |
| 23532991 | Background | 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. |
| 30003346 | Background | 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. |
| 15929752 | Background | 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. |
| 29845397 | Background | 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. |
| 30004814 | Background | 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. |
| 30010475 | Background | 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. |
| 25379861 | Background | 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. |
| 24619293 | Background | 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. |
| 26341463 | Background | 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. |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |