Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy

Obesity Clinical Trial

— ROSE  

Official title:

Reflux in the Obese Undergoing Surgery or Endoscopy (ROSE) Previously: Gastroesophageal Reflux Disease (GERD) in Bariatric Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03705416
• Other study ID #: IRB00186052
• Secondary ID: The ROSE study
• Status: Active, not recruiting
• Start date: March 30, 2019
• Est. completion date: March 30, 2028

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: March 30, 2028
• Est. primary completion date: March 30, 2025
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• GERD
• Obesity

Intervention

Procedure:
• Endoscopy
endoscopic suturing of stomach
• Surgery
Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	Memorial Hermann Health System	Houston	Texas
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	Utah-Health: University of Utah	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Reflux esophagitis	Incidence of GERD-related complications	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Prevalence and incidence of silent reflux	Proportion of patients with abnormal AET without symptoms after bariatric treatment procedure	1 year
Secondary	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