ESG Use for Weight Loss in Obese UC Patients Undergoing Colectomy With IPAA

Overview

About this study

The purpose of this study is to evaluate the effectiveness and safety 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). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • BMI 30-50 kg/m^2 for at least 6 months prior to ESG.
  • Ages 22-69.
  • 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.

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.

Eligibility last updated 8/26/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Amanda Johnson, M.D.

Open for enrollment

Contact information:

Abigail Stromme

(507) 538-8238

DLRSTIPAAinfo@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20556627

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