Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy

NCT03705416 | Active Not Recruiting DMC

• 2 other identifiers: IRB00186052The ROSE study
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

GERD; Obesity

Keywords

GERD; Bariatric surgery; Endoscopic sleeve gastroplasty; Sleeve gastrectomy; Roux-en-Y gastric bypass

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Difference in BMI after the bariatric procedure

  5 years

• Reflux esophagitis

  5 years

• GERD severity based on standardized Reflux Disease Questionnaire (RDQ)

  3,6,12,24,26,48, and 60 months post procedure

• GERD severity as assessed by GERD-Health related quality of life (HRQL) score

  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

  5 years

Study Arms (2)

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

Procedure: Endoscopy

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

Procedure: Surgery

Interventions

Endoscopy PROCEDURE

endoscopic suturing of stomach

Also known as: Endoscopic sleeve gastroplasty or ESG

Endoscopic sleeve gastroplasty

Surgery PROCEDURE

Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure

Also known as: Surgical reduction or bypass

Surgery (VSG or RYGBP)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• BMI ≥ 30 Kg/m2
• 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

You may not qualify if:

• Any patient with BMI \< 30 Kg/m2
• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (6)

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Northwell Health

New Hyde Park, New York, 11040, United States

Location

Weill Cornell

New York, New York, 10021, United States

Location

Legacy Oregon Clinic

Portland, Oregon, 97213, United States

Location

Memorial Hermann Health System

Houston, Texas, 77401, United States

Location

Utah-Health: University of Utah

Salt Lake City, Utah, 84132, United States

Location

Related Publications (11)

• 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.

  PMID: 16928254 BACKGROUND

• 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.

  PMID: 21424733 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.

  PMID: 23532991 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.

  PMID: 30003346 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.

  PMID: 15929752 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.

  PMID: 29845397 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.

  PMID: 30004814 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.

  PMID: 30010475 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.

  PMID: 25379861 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.

  PMID: 24619293 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.

  PMID: 26341463 BACKGROUND

MeSH Terms

Conditions

Gastroesophageal Reflux; Obesity

Interventions

Endoscopy; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures

Study Officials

• Marcia I Canto, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: October 15, 2018
• Study Start: March 30, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 30, 2028
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: available in 6 years
• Access Criteria: Project submission to PI and or Heartburn Registry management team then if project accepted, security clearance and enrollment in REDCap and tutorial completions.

Locations

US (6)