Long Term Outcomes of Bariatric Patients Treated With Surgery or Endoscopy
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology, Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 12/21/2018 |
| Start Date: | March 1, 2019 |
| End Date: | September 30, 2028 |
| Contact: | Marcia I Canto, MD |
| Email: | mcanto1@jhmi.edu |
| Phone: | 3013469811 |
Gastroesophageal Reflux Disease (GERD) in Bariatric Patients
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.
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.
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.
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
We found this trial at
1
site
3400 N Charles St
Baltimore, Maryland 21205
Baltimore, Maryland 21205
410-516-8000
Phone: 301-346-9811
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
Click here to add this to my saved trials
