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The aim of this monocentric, prospective, non randomised study with 25 healthy volunteers is to assess anorectal function ( i.e rectal compliance and sensory thresholds) in health with a short protocol barostat versus conventional procedures (i.e. standard barostat protocol and high resolution anorectal manometry). Anorectal dysfunction is a key mechanism in the development of fecal incontinence and symptoms of obstructive defecation.
In this study volunteers will be examined - after explanation, physical examination and verification of in- and exclusion criteria - by anorectal barostat with short and standard protocol as well as by proctoscopy and endoanal ultrasound.
For a coordinated anorectal function in addition to the anal sphincter the perception of rectal distension (visceral perception) and elasticity / compliance of the anorectum and stool consistency is important. A disturbed anorectal function may lead to functional defecation disorders or incontinence.
The currently available methods for measuring physiological assessment of anorectal function mostly focus on measurement of sphincter pressures, but generally provide no complete explanation for the underlying pathophysiology of defecation disorders. By voluntary contraction of the striated muscles of the external anal sphincter and puborectalis muscle defecation can be further delayed. In addition, however, other continence mechanisms play an important role.
The Group for the Study of functional gastrointestinal disorders at the Clinic for Gastroenterology at the University Hospital of Zurich has a great expertise in the establishment of new research methods such as the already in routine clinical practice used high-resolution anorectal manometry and has conducted numerous studies with anorectal Barostat. To use the results of Barostat also in everyday clinical practice in patients with defecation disorders this technique means significant simplification of the instrumental methodology and shortening of the work described in the literature. Before the simplified barostat can be used with the shortened protocol in different patient groups and clinical practice, it generally requires the validation of the technique in healthy subjects to define the range of normal values.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anorectal manometry | Device | High-resolution anorectal manometry is done under standard clinical conditions with a 10 cm catheter inserted into the rectum loaded with pressure transducers at a distance of 6 mm in the sphincter area and an attached latex balloon at the catheter tip. It will measure the length of the anal sphincter, the static pressure and the clamping pressure during at least 3 over 40 seconds sustained maneuvers according to a standardized protocol. Mean and maximum pressure increase over the resting pressure during the first 30 seconds of the squeeze and the maximum possible squeeze time will be documented. Moreover, the initial anorectal perception threshold, the perception of urge to defecate and maximum tolerable volume balloon will be documented. |
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| barostat | Device | For the barostat study a balloon will be attached to the catheter. Instead of a barostat machine a 60ml syringe and a sphygmomanometer will be connected to the catheter and the catheter will be positioned in the rectum. The balloon is then dilated gradually to assess perception, urge and discomfort threshold in relation to rectal volume. |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of anorectal perception thresholds with short protocol barostat in healthy volunteers | during hospital stay, estmated 0.5 days |
| Measure | Description | Time Frame |
|---|---|---|
| anorectal perception thresholds in % in relation to rectal capacity assessed in ml | Comparison of anorectal perception thresholds and rectal capacity with the simplified barostat protocol with:
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich | Study Director |
| Heiko Fruehauf, MD | University Hospital Zurich, Division of Gastroenterology and Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich, Gastroenterology and Hepatology | Zurich | 8091 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24517865 | Derived | Sauter M, Heinrich H, Fox M, Misselwitz B, Halama M, Schwizer W, Fried M, Fruehauf H. Toward more accurate measurements of anorectal motor and sensory function in routine clinical practice: validation of high-resolution anorectal manometry and Rapid Barostat Bag measurements of rectal function. Neurogastroenterol Motil. 2014 May;26(5):685-95. doi: 10.1111/nmo.12317. Epub 2014 Feb 12. |
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| at time of hospital stay approx 0.5 days |