Normal Values for High-Resolution Anorectal Manometry in IPAA
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: 18-001182
Sponsor Protocol Number: 18-001182
About this study
The purpose of this study is to determine normal values of anorectal manometry (ARM) in asymptomatic patients with an ileal pouch-anal anastomosis (IPAA), and to compare pouch evacuation dynamics between those who are asymptomatic with assumed normal pouch function and those with symptoms suggestive of a pouch evacuation disorder.
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:
- Patients must be between the ages of 18 and 65, who have undergone TAC with IPAA for any indication (i.e., ulcerative colitis, indeterminate colitis, FAP).
- All patients will have had closure of ileostomy, with reinstitution of fecal stream through the ileal pouch, at least 1 year prior to enrollment in the study.
- Fifteen patients with and 15 without symptoms suggestive of a defecatory disorder based on Rome IV questionnaire for functional defecation disorders will be enrolled in this study (considered symptomatic for a response of at least ‘often’ to any of the following questions:
- Straining during bowel movements;
- Feeling of incomplete evacuation;
- Sensation of blocked stools;
- Manual maneuvers to facilitate defecation;
- Difficulty relaxing to allow defecation for at least the previous 6 months.
- Subjects will have their vital signs checked and documented at their screenining visits:
- Height;
- Weight;
- Temperature;
- Blood pressure.
- Subjects will also undergo a physical exam which will include an abdominal exam and a rectal exam. The Rome IV and SIBDQ questionnaires will be asked at screening.
Exclusion Criteria:
- Female patients who are pregnant.
- Patients unable to give informed consent.
- Patients with significant cardiovascular, respiratory, neurological, psychiatric, or endocrine disease will be excluded from the study.
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 Kevin Quinn, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available