Understanding Mechanisms of Normal and Disordered Defecation
Mayo Clinic
160 participants
Jan 29, 2019
INTERVENTIONAL
Conditions
Summary
Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
Eligibility
Inclusion Criteria6
- Male and female 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.
- 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 Criteria7
- 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 and anticholinergic 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.
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Interventions
Contractions will be recorded with a balloon inserted into the rectum and inflated
Rectum will be filled with a small amount of paste.Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03842007