Anorectal Pressures and Simultaneous Dynamic Imaging

Overview

About this study

Many people have constipation because they cannot defecate. However, we do not fully understand the mechanisms of normal defecation or constipation. We are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.

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 for Controls.

  • Healthy male (N=30) and female (N=30) volunteers aged 18-80 years.

  • Having capacity to provide written informed consent before participating in the study.

  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Inclusion Criteria for Constipated Patients.

  • Male and female volunteers aged 18-80 years.

  • Individuals with chronic constipation for 1 year, with 2 or more of the following symptoms for 3 months or longer: <3 bowel motions/week, straining ≥ 25% of time, hard or lumpy stools ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.

  • Having capacity to provide written informed consent before participating in the study.

  • Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

 

Exclusion Criteria for Controls (Items indicated with an asterisk are also exclusion criteria for patients).

  • Clinical evidence of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric or other disease that may interfere with the objectives of the study and/or pose safety concerns.*

  • Current symptoms of a functional gastrointestinal disorder assessed by questionnaire [2, 16].

  • Putative risk factors for pelvic floor trauma: i.e. six or more vaginal deliveries, birthweight >4500gms (macrosomia), or known 3rd or 4th degree perineal tear.

  • Medications that are likely to alter gastrointestinal motility: e.g., opiates, anticholinergic medications, serotoninergic agents, alpha adrenergic agonists, calcium channel or b blockers; a stable dose of thyroxine will be permitted (i.e. no alterations in dose for the preceding three months).

  • Active rectal inflammation, cancer; perianal sepsis; history of pelvic radiation, rectosigmoid surgery or inflammatory bowel disease.*

  • Anxiety or depression as assessed by the Hospital Anxiety and Depression Questionnaire [17].

  • Contraindications for MR imaging: i.e. pacemakers, aneurysm clips, cochlear implants.*

  • Pregnant women, prisoners and institutionalized individuals.*

     

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

Adil Bharucha, M.B.B.S., M.D.

Open for enrollment

Contact information:

Kelly Feuerhak CCRP

(507)255-6802

Feuerhak.Kelly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available