Endoscopic Metabolic and Bariatric Therapies
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years
时间窗: 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 hypertension from pre-procedure to 10 years using medication dosages
时间窗: 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
时间窗: 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 in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years
时间窗: 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 Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years
时间窗: 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 comorbidity medication dosages from baseline to 10 years
时间窗: 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 weight from pre-procedure to 10 years
时间窗: 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
时间窗: 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 total cholesterol lab values (mg/dL) from pre-procedure to 10 years
时间窗: 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 rate of adverse events from procedure to 10 years
时间窗: 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 low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years
时间窗: 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.
Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years
时间窗: 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 High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years
时间窗: 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.
次要结局
- Change in gastric motility from baseline to 10 years(Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.)
- Change in GLP1 gut hormones from baseline to 10 years(Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.)
- Change in PYY gut hormones from baseline to 10 years(Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.)
- Change in ghrelin hormones from baseline to 10 years(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(Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery)
研究者
Christopher C. Thompson, MD, MSc
Director of Endoscopy
Brigham and Women's Hospital