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
Conditions
Keywords
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)
Brief summary
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
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.
Interventions
PROCEDUREPrimary Obesity Endoscopic Procedures
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).
PROCEDUREEndoscopic Revision of Bariatric Surgical Procedures
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.
PROCEDUREBariatric Surgery Procedures
Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)
DEVICEEndoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction
Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.
DEVICEIntragastric Balloon
An endoscopic bariatric procedure involving the placement of an intragastric balloon.
DEVICEPrimary obesity surgery endoluminal, Restorative obesity surgery endoluminal
Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.
DEVICEArgon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy
Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.
DEVICEAspiration Therapy
Placement of an aspiration therapy device for the treatment of obesity.
Sponsors
Christopher C. Thompson, MD, MSc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in comorbidity medication dosages from baseline to 10 years | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change of dosage of comorbidity medications compared to baseline |
| Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change in HDL measurements by comparing followup lab values (mg/dL) to baseline. |
| Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years. |
| Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years. |
| Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years. |
| Change in rate of adverse events from procedure to 10 years | Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change in rate of adverse events post-procedure through 10 years |
| Change in weight from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | %TBWL |
| Change in hypertension from pre-procedure to 10 years using blood pressure measurements | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline. |
| Change in hypertension from pre-procedure to 10 years using medication dosages | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline. |
| Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years. |
| Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change of HgA1c (%) by comparing lab values from baseline through 10 years. |
| Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline. |
| Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years | Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. | Change in LDL measurements by comparing followup lab values (mg/dL) to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PYY gut hormones from baseline to 10 years | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | PYY lab values will be compared to baseline |
| Change in GLP1 gut hormones from baseline to 10 years | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | GLP1 lab values will be compared to baseline |
| Change in ghrelin hormones from baseline to 10 years | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | Ghrelin lab values will be compared to baseline |
| Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years | Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery | Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures |
| Change in gastric motility from baseline to 10 years | Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10. | Gastric emptying breath test |
Countries
United States
Outcome results
None listed