A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

Launched by MAYO CLINIC · Feb 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a procedure called Endoscopic Sleeve Gastroplasty (ESG), which is designed to help people with obesity lose weight. The focus is on individuals who have ulcerative colitis (a condition that affects the intestines) and are preparing for a surgery called colectomy, which is part of a plan to eventually create a special pouch for waste removal (known as ileal pouch anal anastomosis or IPAA). The goal of the study is to find out how safe and effective ESG is for these patients.

To be eligible for the trial, participants should have a body mass index (BMI) between 30 and 50 for at least six months and must have been diagnosed with ulcerative colitis and be planning to undergo the colectomy. They also need to be willing to follow specific diet and behavior changes related to the procedure. Throughout the study, participants can expect to attend regular visits for assessments and support. It’s important to note that there are certain medical conditions and previous surgeries that may prevent someone from participating, so it’s best for individuals to talk to their healthcare provider to see if this trial is right for them.

Gender

ALL

Eligibility criteria

• 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