Normal Values for High-Resolution Anorectal Manometry in IPAA

Overview

Información sobre este estudio

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. 

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

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.

 

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus

Rochester, Minn.

Investigador principal de Mayo Clinic

Kevin Quinn, M.D.

Cerrado para la inscripción

More information

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CLS-20423272

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