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.
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.
Study Type
OBSERVATIONAL
Enrollment
5,000
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).
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.
Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)
Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.
An endoscopic bariatric procedure involving the placement of an intragastric balloon.
Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.
Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.
Placement of an aspiration therapy device for the treatment of obesity.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Change in weight from pre-procedure to 10 years
%TBWL
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in hypertension from pre-procedure to 10 years using blood pressure measurements
Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.
Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in hypertension from pre-procedure to 10 years using medication dosages
Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in gastric motility from baseline to 10 years
Gastric emptying breath test
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery
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