Normal Values for High-Resolution Anorectal Manometry in IPAA

Overview

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 Contact

Rochester, Minn.

Mayo Clinic principal investigator

Kevin Quinn, M.D.

Closed for enrollment

Contact information:

Jessica Friton

(507) 284-0495

Friton.Jessica@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20423272

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