Obesity, Ulcerative Colitis
Conditions
Keywords
ESG, IPAA
Brief summary
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.
Interventions
DEVICEApollo Endoscopic Suture System
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.
BEHAVIORALLifestyle Intervention
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.
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* BMI 30-50 kg/m2 for at least 6 months prior to ESG * Diagnosis of UC with plans to undergo or who have already undergone colectomy as part of a plan to pursue eventual 3-stage ileal pouch anal anastomosis (IPAA) * Willing to adhere to the diet and behavior modifications required for ESG * Able to follow the visit schedule * Able to provide informed consent * If female, be either post-menopausal, surgically sterile, or agree to practice birth control during year of study and have negative serum Human Chorionic Gonadotropin (HCG) at screening/baseline
Exclusion criteria
* Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESG * Current or recent (last six months) gastric or duodenal ulceration * Esophageal or gastric varices * Significant motility disorder of the esophagus or stomach * Large hiatal hernia measuring \>5 cm or ≤ 5 cm and associated with severe gastroesophageal reflux * Severe coagulopathy, hepatic insufficiency, or cirrhosis * Gastric mass * Presence of any other medical condition which precludes safe performance of elective endoscopy such as poor general health and/or history of severe hepatic, cardiac, or pulmonary disease * Serious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visits * Unwilling to participate in an established diet and behavior modification program, with routine follow-up * Ongoing corticosteroid use at a dose of \>5 mg daily * Daily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervision * Alcohol or drug addiction * Females who are pregnant, nursing, or planning pregnancy within the next year * Concomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparations * Has a condition or is in a situation which in the investigator's opinion may put the subject at significant risk or may interfere significantly with the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Total Body Weight Loss | 6 months | 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. |
| Number of Subjects With Serious Adverse Events | 24 months | Total number of subjects to report serious adverse event related to the ESG procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Early Peri-operative Complications | 1 year following procedure | Number of early (less than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure |
| Number of Late Peri-operative Complications | 1 year following procedure | Number of late (greater than 30 days) peri-operative complications related to IPAA and ileostomy takedown clinical standard of care procedure |
| Change Gastrointestinal Symptom Rating Scale (GSRS) | Week 4, Week 12, Week 24, 12 months post-ileostomy takedown | 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." |
| Modified Pouchitis Disease Activity Index (mPDAI) | 12 months post-ileostomy takedown | 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. |
| Durable Weight Loss | 12 months and 12 months post-ileostomy takedown | Number of subjects to achieve durable weight loss |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmanda M Johnson, MD
Mayo Clinic
Participant flow
Recruitment details
Recruitment occurred at a single center, Mayo Clinic Rochester. Participants were identified using patient-matching tools to screen for potential eligibility. Individuals identified as potentially eligible were then contacted through approved outreach methods and invited to undergo further eligibility screening.
Pre-assignment details
2 subjects were enrolled on the study, 1 of which screen failed prior to randomization. As only 1 participant was randomized in this study, no data is reported here in order to protect and maintain participant privacy/confidentiality.
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed