Endoscopic Metabolic and Bariatric Therapies

Study Overview
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Brief Summary
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This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

Detailed Description
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The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

Official Title
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Endoscopic Metabolic and Bariatric Therapies

Conditions
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Obesity, Obesity, Morbid, Obesity Associated Disorder, Bariatric Surgery Candidate, Fistula, Gastric, Roux-en-y Anastomosis Site, Ulcer, Gastric, Abdominal Pain, Abdominal Obesity, Complication of Surgical Procedure, Complication of Treatment, Complication,Postoperative, Weight Gain, Weight Loss, Leak, Anastomotic, Delayed Gastric Emptying Following Procedure

Intervention / Treatment
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* Procedure: Primary Obesity Endoscopic Procedures
* Procedure: Endoscopic Revision of Bariatric Surgical Procedures
* Procedure: Bariatric Surgery Procedures
* Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction
* Device: Intragastric Balloon
* Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal
* Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy
* Device: Aspiration Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients from Mass General Brigham any patient having an endoscopic primary obesity procedure any patient having an endoscopic post-bariatric surgical revision procedure any patient having a bariatric surgical procedure Exclusion Criteria: patients without past surgical and medical history medical records in the Mass General Brigham system patients unwilling to allow for medical record review at Mass General Brigham

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Obesity Endoscopic Procedures<br>Primary endoscopic procedures for treatment of obesity. | Procedure: Primary Obesity Endoscopic Procedures<br>* Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).<br>* Other names: ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs;Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction<br>* Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.<br>* Other names: ESG, TORe;Device: Intragastric Balloon<br>* An endoscopic bariatric procedure involving the placement of an intragastric balloon.<br>* Other names: IGB;Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal<br>* Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.<br>* Other names: POSE, ROSE;Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy<br>* Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.<br>* Other names: APC, GEM, BEAM, PSAM;Device: Aspiration Therapy<br>* Placement of an aspiration therapy device for the treatment of obesity.<br>* Other names: Aspire;|
| Endoscopic Revision of Bariatric Surgical Procedures<br>Endoscopic revision of post-bariatric surgical complications. | Procedure: Endoscopic Revision of Bariatric Surgical Procedures<br>* Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.<br>* Other names: TORe, ROSE, APC;Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction<br>* Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.<br>* Other names: ESG, TORe;Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal<br>* Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.<br>* Other names: POSE, ROSE;Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy<br>* Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.<br>* Other names: APC, GEM, BEAM, PSAM;|
| Bariatric Surgery Procedures<br>Bariatric surgical procedures. | Procedure: Bariatric Surgery Procedures<br>* Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)<br>* Other names: RYGB, LSG, LAGB;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from pre-procedure to 10 years | %TBWL | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in hypertension from pre-procedure to 10 years | Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in hypertension from pre-procedure to 10 years | Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years | Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years | Change of HgA1c (%) by comparing lab values from baseline through 10 years. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years | Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years | Change in LDL measurements by comparing followup lab values (mg/dL) to baseline. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years | Change in HDL measurements by comparing followup lab values (mg/dL) to baseline. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years | Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years | Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years | Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years. | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in rate of adverse events from procedure to 10 years | Change in rate of adverse events post-procedure through 10 years | Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in comorbidity medication dosages from baseline to 10 years | Change of dosage of comorbidity medications compared to baseline | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in gastric motility from baseline to 10 years | Gastric emptying breath test | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in PYY gut hormones from baseline to 10 years | PYY lab values will be compared to baseline | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in GLP1 gut hormones from baseline to 10 years | GLP1 lab values will be compared to baseline | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Change in ghrelin hormones from baseline to 10 years | Ghrelin lab values will be compared to baseline | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | 
| Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years | Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures | Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Roux-en-Y Gastric Bypass, Sleeve Gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy, pylorus sparing antral myotomy (PSAM), gastric emptying breath test (GEBT)