A Study to Understand the Mechanisms of Normal and Disordered Defection

Overview

About this study

The purpose of this study is to compare rectal emptying and rectoanal pressures in healthy people and DD. Our hypotheses are that (i) the rate and amount of rectal emptying is higher in healthy people than in patients with DD, (ii) some patients with symptoms of DD will have a normal balloon expulsion test but reduced rectal emptying measured with fecomanoflowmetry, and (iii) compared to healthy people, the rectal pressure increment and/or anal relaxation is reduced in patients with DD.
 

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. Please contact the study team to discuss whether or not you are eligible to participate in a study.

Inclusion Criteria for Controls:

  • Healthy volunteers aged 18-80 years.
  • Able 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, anal digitation ≥ 25% of time, incomplete evacuation ≥ 25% of time, feeling of anorectal blockage ≥ 25% of time.
  • Able 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 marked with an asterisk also apply to 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.
  • 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 andanticholinergic medications; a stable dose of thyroxine and low doses of tricyclic agents (e.g., up to amitriptyline (50 mg daily).
  • 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.
  • 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

.
CLS-20450326

Mayo Clinic Footer