A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

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 ulcerative colitis (UC) patients undergoing colectomy with eventual Ileal Pouch Anal Anastomosis (IPAA) compared to counseling on diet and lifestyle interventions alone.

Inclusion Criteria:BMI 30-50 kg/m2 for at least 6 months prior to ESGDiagnosis 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 ESGAble to follow the visit scheduleAble to provide informed consentIf 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/baselineExclusion Criteria:Prior gastric or bariatric surgery or other alteration to upper gastrointestinal anatomy which would preclude safe or technical performance of ESGCurrent or recent (last six months) gastric or duodenal ulcerationEsophageal or gastric varicesSignificant motility disorder of the esophagus or stomachLarge hiatal hernia measuring >5 cm or ≤ 5 cm and associated with severe gastroesophageal refluxSevere coagulopathy, hepatic insufficiency, or cirrhosisGastric massPresence 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 diseaseSerious or uncontrolled psychiatric illness which may compromise patient understanding of procedure or compliance with follow-up visitsUnwilling to participate in an established diet and behavior modification program, with routine follow-upOngoing corticosteroid use at a dose of >5 mg dailyDaily use of anti-inflammatory agents such as non-steroidal medications, or anticoagulants without medical supervisionAlcohol or drug addictionFemales who are pregnant, nursing, or planning pregnancy within the next yearConcomitant use of or unwillingness to avoid any use of weight loss medications, weight loss supplements, or weight loss herbal preparationsHas 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