The Relationship Between Endoscopic Inflammation and Health-related Quality of Life in Patients with Ulcerative Colitis
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 17-001572
Sponsor Protocol Number: 17-001572
About this study
Primary Aim
We aim to evaluate: 1) the correlation between patient-reported rectal bleeding and stool frequency and health-related quality of life focused on fatigue, depression and anxiety, and work productivity; and 2) the correlation between the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.
Secondary Aims
We also aim to evaluate the correlation between the combination of clinical/PRO and the severity of endoscopic inflammation and health-related quality of life focused on fatigue, depression and anxiety, and work productivity.
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:
Consecutive patients with ulcerative colitis who attend the IBD Clinic in the Division of Gastroenterology and Hepatology at Mayo Clinic in Rochester and who have been scheduled for a clinical sigmoidoscopy or colonoscopy for assessment of disease activity or colorectal cancer surveillance.
Exclusion Criteria:
- active cancer diagnosis (not fully treated),
- the presence of other chronic immune-mediated diseases such as spondyloarthropathy,
- primary sclerosing cholangitis,
- previous partial colectomy,
- perianal disease including fissures and fistulas,
- previous pelvic radiation,
- rectal prolapse,
- anal sphincter incompetence,
- celiac disease,
- microscopic colitis,
- chronic laxative use, and
- pregnancy.
- Patients with proctocolectomy and ileal pouch-anal anastomosis
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator Edward Loftus, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available