Understanding Mechanisms of Normal and Disordered Defecation
- Conditions
- Constipation
- Interventions
- Diagnostic Test: Rectal Barostat StudyDiagnostic Test: Fecoflowmetry
- Registration Number
- NCT03842007
- Lead Sponsor
- Mayo Clinic
- Brief Summary
Researchers are trying to better understand why constipation occurs and improve the tests for diagnosing these conditions.
- Detailed Description
Study includes a screening visit and a study day. During the initial screening visit for this study, subjects will complete three (3) questionnaires about their bowel symptoms, overall health, and anxiety and depression. A blood sample (about 4 tablespoons) will be drawn to study the relationship between genes and certain bowel habits. Subjects will be asked to provide a single stool sample to look at the bacteria in the stool.
Before the study, subjects will receive 1 to 2 Fleet's enemas to clean the rectum. After receiving the Fleet's enema (administered through a small plastic tube in the rectum), a swab attached to a small rectal catheter will be used to brush the lining of the rectum and obtain a stool specimen. Then, rectal and anal pressures will be measured by placing a small catheter (plastic tube) in the rectum, and withdrawing it slowly. Rectal sensation will be measured by inflating a small balloon in the rectum.
There are 2 procedures (rectal barostat study and fecomanoflowmetry), each of which lasts approximately 90 minutes. During the rectal barostat study, contractions will be recorded with a balloon inserted into the rectum and inflated. After the barostat study is completed, your 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). Then, you will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 160
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Individuals Fecoflowmetry Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry Healthy Individuals Rectal Barostat Study Sixty healthy individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry Constipated Individuals Rectal Barostat Study 60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry Constipated Individuals Fecoflowmetry 60 constipated individuals (20 men and 40 women) will undergo an anorectal study which comprises of a rectal barostat study followed by fecoflowmetry
- Primary Outcome Measures
Name Time Method Rectal emptying Baseline Measured by fecomanoflowmetry calculating the mean and maximum flow rate in various conditions (mg/sec), defecated volume (mg), flow time (sec) and time to maximum flow (sec). The amount of artificial stool evacuated is expressed in milligrams. The duration is in seconds. These 2 metrics are integrated to measure mg evacuated/second.
Rectoanal pressures Baseline Measured by anorectal manometry in mmHg
- Secondary Outcome Measures
Name Time Method Rectal contractile response to distention measured with a sinusoidal oscillator Baseline Rectal balloon is inflated to a preload volume of 125ml. The balloon is then oscillated around baseline volume by 25mL for 20 min at a frequency of 5 counts per minute (cpm). The mean rectal pressure (cm H2O) will be calculated over the multiple oscillation cycles within the 20 minute distention segment.
Rectal compliance measured with a barostat Baseline Pressure (mmHg) corresponding to half-maximum rectal volume during rectal distention
Rectal sensory threshold for first sensation to defecate using barostat balloon distention Baseline The sensory threshold for first sensation to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the first sensation to defecate.
Rectal Capacity measured with a barostat Baseline Rectal volume (ml) at maximum distending pressure during rectal distention
Rectal sensory threshold for maximum urgency during barostat balloon distention Baseline The sensory threshold for maximum urgency to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the maximum urgency to defecate.
Rectal balloon expulsion time Baseline During this test, the time (seconds) required to expel a water-filled rectal balloon (50 ml) will be compared between healthy people and patients
Anal sphincter electromyography (EMG) Baseline Units - mV
Rectal sensory threshold for desire to defecate using barostat balloon distention Baseline The sensory threshold for desire to defecate is measured by stepwise inflation of the balloon (0-44 mm Hg, at 4 mm Hg increments). During this assessment participants are asked to report when they have the desire to defecate.
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States