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Gastroesophageal reflux disease (GERD) is a frequently seen entity after sleeve gastrectomy. Management of GERD after sleeve is difficult given limited treatment modalities. Stretta is an endoscopic FDA approved device that improves symptoms of GERD, there is minimal information about its use on patients after sleeve. This registry will attempt to get information regarding the treatment of reflux using Stretta after sleeve gastrectomy.
Gastroesophageal reflux disease (GERD) is a widely prevalent medical disorder in the United States with a spectrum of treatment options ranging from dietary modification, to various pharmacologic treatments, to an array of available surgical and endoscopic procedures. There is a well-described correlation between obesity and symptoms of GERD. The morbidly obese patients undergoing evaluation for bariatric surgery are to characterize any GERD-like symptoms as this will assist in directing surgical therapy. Generally, it is recommended that patients with severe GERD undergo Roux-en-Y gastric bypass(RYGB) rather than a sleeve gastrectomy (SG) as RYGB has proven to be the most effective surgical treatment for GERD in the morbidly obese patient. The number of bariatric procedures performed in the United States has increased significantly in the recent years. Out of all bariatric procedures SG is the most commonly performed in the United States, as it has proven to be a very safe procedure with excellent weight loss. However, the incidence of de novo GERD and the effect of SG on patients with preexisting GERD remain controversial. Although some authors report high incidence of de novo GERD and worsening of previous reflux symptoms, there is also data showing improvement of symptoms post SG. Management of GERD after SG poses an interesting challenge, as traditional invasive procedures like Nissen fundoplication are not available due to an altered gastric anatomy. The alternative is to perform a conversion to RYGB, which represents increased morbidity to patient and significant cost.
A large number of endoscopic procedures have been introduced in the past for the management of GERD as an alternative to the surgical anti-reflux procedures with various degrees of success. One of the few non-invasive methods for managing GERD that is still available on the market and widely used is Stretta. Stretta delivers Radio Frequency energy (RFe) to the LES resulting in increased LES pressure. In 2000, the FDA approved the Stretta system for treatment of GERD. Stretta allows an alternative for treatment in patients who are not willing or able to undergo surgery. The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published clinical practice guidelines that endorsed Stretta as an appropriate therapy for treatment of GERD in patients >18, with at least 6 months of symptoms partially or completely responsive to pharmacotherapy and who are unable or unwilling to undergo laparoscopic Nissen fundoplication. There are to date no studies evaluating the use of Stretta in management of patients with GERD symptoms after sleeve gastrectomy.
The investigators will study sleeve gastrectomy patients with GERD symptoms and if considered candidates for Stretta all patients will be enrolled in data collection cohort and followed prospectively with symptom questionnaire and quality of life scores for improvement of symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiofrequency Energy to the Lower Esophageal Sphincter (LES) | Experimental | All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stretta | Device | Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score | RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem. | 6 months |
| Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score | RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem. | 12 months |
| Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score | RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem. | 24 months |
| Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score | GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms. | 6 months |
| Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score |
| Measure | Description | Time Frame |
|---|---|---|
| Esophageal pH Levels | All patients will have pH monitoring conducted at baseline pre-procedurally. The number of patients with abnormal pH levels will be tabulated. Bravo capsule monitoring will be used for evaluation. | Baseline |
| Esophageal pH Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erin Moran-Atkin, MD | Assistant Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States | ||
| Stanford University Medical Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | Radiofrequency Energy to the Lower Esophageal Sphincter (LES) | All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms. Stretta: Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED. Radiofrequency (RF) Energy to the LES (Stretta Procedure): The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2016 |
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| Radiofrequency (RF) Energy to the LES (Stretta Procedure) | Procedure | The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures. |
|
GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms. |
| 12 months |
| Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score | GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms. | 24 months |
If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation.
| 6 months |
| Esophageal pH Levels | If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation. | 12 months |
| Use of Anti-reflux Medication | The number of patients using anti-reflux medications will be tabulated. | Baseline |
| Cessation or Decreased Use of Anti-reflux Medication | The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated. | 6 months |
| Gastric Emptying Study | A Gastric emptying study will be conducted for all patients at 1, 2, 3, and 4 hours. Patients with severe gastroparesis (>50% retention at 4 hours) will be excluded from study | Baseline (up to 4 hours) |
| Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy | If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 6 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy. | 6 months |
| Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy | If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 12 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy. | 12 months |
| EGD Abnormalities | An EGD will be obtained for all patients at baseline. Biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathophysiology. | Baseline |
| EGD Abnormalities | In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined. | 6 months |
| EGD Abnormalities | In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined. | 12 months |
| Stanford |
| California |
| 94305 |
| United States |
| Norwalk Hospital | Norwalk | Connecticut | 06856 | United States |
| Gastroenterology Clinic of Acadiana | Lafayette | Louisiana | 70503 | United States |
| Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Montefiore Medical Center | The Bronx | New York | 10467 | United States |
| Duke University Health System | Durham | North Carolina | 27710 | United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Health System | Cleveland | Ohio | 44119 | United States |
| Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Houston Methodist Hospital | Houston | Texas | 77030 | United States |
| Memorial Hermann-Texas Medical Center | Houston | Texas | 77030 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Radiofrequency Energy to the Lower Esophageal Sphincter (LES) | All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms. Stretta: Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED. Radiofrequency (RF) Energy to the LES (Stretta Procedure): The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Improved Symptoms Based on Reflux Symptom Index (RSI) Score | RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem. | Study was terminated early and no 6 month RSI data were collected. As such, there were no RSI scores to aggregate and report. | Posted | 6 months |
|
| |||||||||||||||||||
| Primary | Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score | RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem. | Study was terminated early and no 12 month RSI data were collected. As such, there were no RSI scores to aggregate and report. | Posted | 12 months |
|
| |||||||||||||||||||
| Primary | Number of Patients With Improved Symptoms Based on Reflux Severity Index (RSI) Score | RSI scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 9-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 = No Problem to 5 = Severe Problem. | Study was terminated early and no 24 month RSI data were collected. As such, there were no RSI scores to aggregate and report. | Posted | 24 months |
|
| |||||||||||||||||||
| Primary | Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score | GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms. | Study was terminated early and no 6 month GERD-HRQL data were collected. As such, there were no results to aggregate and report. | Posted | 6 months |
|
| |||||||||||||||||||
| Primary | Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score | GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms. | Study was terminated early and no 12 month GERD-HRQL data were collected. As such, there were no results to aggregate and report. | Posted | 12 months |
|
| |||||||||||||||||||
| Primary | Number of Patients With Improved Symptoms Based on GERD Health Related Quality of Life (GERD-HRQL) Questionnaire Score | GERD-HRQL scores will be used to determine whether patients achieved at least a 50% reduction in symptoms as compared to baseline. Patients will be provided a 15-item questionnaire and asked to rate the score that best applies to their symptoms on a 6 point scale ranging from 0 to 5 (overall range from 0-75) with higher scores indicative of worsening symptoms. | Study was terminated early and no 24 month GERD-HRQL data were collected. As such, there were no results to aggregate and report. | Posted | 24 months |
|
| |||||||||||||||||||
| Secondary | Esophageal pH Levels | All patients will have pH monitoring conducted at baseline pre-procedurally. The number of patients with abnormal pH levels will be tabulated. Bravo capsule monitoring will be used for evaluation. | Esophageal samples were not collected and therefore there was no esophageal pH results to report. | Posted | Baseline |
|
| |||||||||||||||||||
| Secondary | Esophageal pH Levels | If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation. | Study was terminated early. Esophageal samples were not collected and therefore there was no esophageal pH results to report. | Posted | 6 months |
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| |||||||||||||||||||
| Secondary | Esophageal pH Levels | If esophageal pH levels at baseline are determined to have been abnormal, the number of patients with symptomatic GERD demonstrating an improvement in esophageal pH exposure following sleeve gastrectomy will be assessed. Bravo capsule monitoring will be used for evaluation. | Study was terminated early. Esophageal samples were not collected and therefore there was no esophageal pH results to report. | Posted | 12 months |
|
| |||||||||||||||||||
| Secondary | Use of Anti-reflux Medication | The number of patients using anti-reflux medications will be tabulated. | Study was terminated early and data related to the use of anti-reflux medications was not collected. As such, there were no related anti-reflux medication data to aggregate and report. | Posted | Baseline |
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| |||||||||||||||||||
| Secondary | Cessation or Decreased Use of Anti-reflux Medication | The number of patients who demonstrate a complete cessation or decrease in use of anti-reflux medications will be tabulated. | Study was terminated early and data related to the cessation or decreased use of anti-reflux medications was not collected. As such, there were no related anti-reflux medication data to aggregate and report. | Posted | 6 months |
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| Secondary | Gastric Emptying Study | A Gastric emptying study will be conducted for all patients at 1, 2, 3, and 4 hours. Patients with severe gastroparesis (>50% retention at 4 hours) will be excluded from study | Study was terminated early and the gastric emptying study was not collected. As such, there were no related gastric emptying data to aggregate and report. | Posted | Baseline (up to 4 hours) |
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| Secondary | Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy | If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 6 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy. | Study was terminated early and data related to gastric dysmotility as a contributing factor to GERD was not collected. As such, there were no 6 month gastric dysmotility results to aggregate and report. | Posted | 6 months |
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| Secondary | Determination of Gastric Dysmotility as a Contributory Factor in GERD Following Sleeve Gastrectomy | If gastric dysmotility is determined to have been abnormal at baseline, the gastric emptying study will be repeated at 12 months to evaluate Gastric Dysmotility will be evaluated as a contributory factor in GERD following sleeve gastrectomy. | Study was terminated early and data related to gastric dysmotility as a contributing factor to GERD was not collected. As such, there were no 12 month gastric dysmotility results to aggregate and report. | Posted | 12 months |
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| Secondary | EGD Abnormalities | An EGD will be obtained for all patients at baseline. Biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathophysiology. | Biopsies were not obtained at baseline and, as such, there were no corresponding results to analyze and report. | Posted | Baseline |
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| Secondary | EGD Abnormalities | In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined. | Study was terminated early. Biopsies were not obtained at 6 months and, as such, there were no corresponding results to analyze and report. | Posted | 6 months |
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| Secondary | EGD Abnormalities | In those patients identified to have abnormal esophageal pathology at baseline, biopsies of any suspicious lesions and any evidence of esophagitis will be obtained and scored in accordance with Los Angeles classification as either Grade A, Grade B, Grade C, or Grade D lesions with each grade denoting progressively more severe pathology. The number of patients demonstrating objective histologic improvement or resolution of esophagitis will be determined. | Study was terminated early. Biopsies were not obtained at 12 months and, as such, there were no corresponding results to analyze and report. | Posted | 12 months |
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Following Stretta procedure through week 4 and every 3 months thereafter up to 24 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Radiofrequency Energy to the Lower Esophageal Sphincter (LES) | All patients that have undergone sleeve gastrectomy as treatment for obesity that have developed severe reflux symptoms will be treated with Stretta (FDA approved device for the management of GERD) and evaluated prospectively for resolution/improvement of reflux symptoms. Stretta: Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED. Radiofrequency (RF) Energy to the LES (Stretta Procedure): The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures. | 0 | 3 | 0 | 3 | 0 | 3 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Erin Moran-Atkin | Montefiore Medical Center | 718-920-4800 | emoran2@montefiore.org |
| Jul 27, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D009765 | Obesity |
| 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 |
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| White Non-Hispanic |
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