The purpose of this research is to gather information on the safety and effectiveness of Endoscopic Sleeve Gastroplasty (ESG) for weight loss in a population of obese UC patients undergoing colectomy with eventual IPAA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Endoscopic Sleeve Gastroplasty (ESG), and endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 70-80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
Low-calorie healthy diet personalized by a dietician according to individual patients' needs and conducive to weight loss. Physical activity will be encourage and assessed.
Mayo Clinic Minnesota
Rochester, Minnesota, United States
RECRUITINGPercent total body weight loss
Percent total body weight loss (%TBWL) calculated by the equation ((baseline screening weight in kilograms (kg) subtracted by follow-up weight in kg) divided by baseline screening weight in kg) times 100.
Time frame: 6 months
Number of subjects with serious adverse events
Total number of subjects to report serious adverse event related to the ESG procedure
Time frame: 24 months
Number of early peri-operative complications
Number of early (less than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure
Time frame: 1 year following procedure
Number of late peri-operative complications
Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure
Time frame: 1 year following procedure
Change gastrointestinal symptom rating scale (GSRS)
ESG tolerance measured by GSRS which includes 15 items and utilizes a 7-point response scale to measure a participant's level of discomfort associated with a given GI symptom, ranging from "No discomfort at all" to "Very severe discomfort."
Time frame: Week 4, Week 12, Week 24, 12 months post-ileostomy takedown
Modified pouchitis disease activity index (mPDAI)
Assess overall pouch function one year following ileostomy takedown using the modified pouchitis disease activity index (mPDAI) score. The mPDAI quantitates clinical symptoms and endoscopic features (edema, granularity, friability, loss of vascular pattern, mucus exudate, and ulceration) on several separate 0-2 point scores, whereby a total score greater than or equal to 5 is indicative of pouchitis.
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Time frame: 12 months post-ileostomy takedown
Durable weight loss
Number of subjects to achieve durable weight loss
Time frame: 12 months and 12 months post-ileostomy takedown