RECRUITING

A Study of Endoscopic Sleeve Gastroplasty for Obesity in Ulcerative Colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Endoscopic Sleeve Gastroplasty (ESG) as a Treatment Option for Obesity in Ulcerative Colitis (UC) Patients Undergoing Colectomy With Ileal Pouch Anal Anastomosis (IPAA)

Quick Facts

Study Start:2023-09-20

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05739162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:22 Years to 69 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

ESG with IPAA Study Team

CONTACT

507-538-8238

DLRSTIPAAinfo@mayo.edu

Abigail A Stromme

CONTACT

507-538-8238

stromme.abigail@mayo.edu

Principal Investigator

Amanda M Johnson, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Minnesota

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Amanda M Johnson, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-20

Study Completion Date2026-01

Study Record Updates

Study Start Date2023-09-20

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

ESG
IPAA

Additional Relevant MeSH Terms

Obesity
Ulcerative Colitis