HealthyPhase 4NCT01456442
Short Protocol Barostat for Assessment of Anorectal Function Versus Standard Protocol Barostat in Healthy Volunteers
A Phase 4 study testing anorectal manometry and barostat in people with Healthy, run by University of Zurich at 1 site in Switzerland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Healthy
- What is being tested?
- anorectal manometry and barostat
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2011to Nov 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Healthy men and women between 18 and 65 years of age without gastrointestinal disease needing medical or surgical treatment.
- No medication (with the exception of occasional intake of paracetamol)
- Availability of all investigations (high resolution anorectal manometry, anorectal barostat with short and standard protocol, proctoscopy and endoanal ultrasound to assess sphincter morphology)
- Good communication with study doctor and meeting of all study requirements.
- Written consent after detailed explanation of study.
Who cannot join
- Gastrointestinal symptoms especially fecal incontinence and obstructed defecation
- Structural or functional changes of upper and lower GI Tract (i.e gastric ulcer, malignancy , symptoms of IBS)
- Symptomatic or manometrically diagnosed motility disorders of the upper and lower GI tract for example anismus
- Surgery or interventions in the lower and upper GI tract (appendectomy and hernia excluded) included congenital malformations
- Pelvic radiation therapy
- Fecal incontinence, defined as involuntary loss of liquid or hard stool
Show all 15Show fewer
- Functional defecation disorders as defined by the ROME III criteria.
- Pregnancy with history of vaginal delivery.
- Acute or chronic disease ( for example IBD)
- Malignancy
- Intake of medication one week prior to study begin. Anticoagulants and medication influencing GI motility like prokinetics, calcium channel blockers and antibiotics
- Drug or alcohol use
- Pregnancy and lactation
- Women at reproductive age will receive pregnancy testing before inclusion into study.
- Physical, mental , neurological or psychiatric conditions limiting ability to meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, 8091
About this study
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.
Read the detailed description
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.
- Conditions
- Healthy
- Being tested
- anorectal manometry, barostat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anorectal manometryDevice
Also called AHRM
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.
barostatDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of anorectal perception thresholds with short protocol barostat in healthy volunteers
Measured: during hospital stay, estmated 0.5 days
Secondary outcomes (1)
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:
- the anorectal perception thresholds and rectal capacity in accordance with the standard protocol
- the pressure of the anal sphincter and the length at rest and during voluntary contraction,
- the length and the morphological integrity of the anal sphincter detected by ultrasound
Measured: at time of hospital stay approx 0.5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2011 (estimated)
- Study startJan 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital ZuerichHeiko Fruehauf, MD, Principal investigator, University Hospital Zurich, Division of Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01456442
- Sponsor's protocol ID
- KEK-ZH-Nr. 2010-0330
- Status last verified
- Nov 2012
- First submitted
- 26 Sep 2011
- Last updated
- 14 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24517865
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Protocol Barostat for Assessment of Anorectal Function Versus Standard Protocol Barostat in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01456442
- Acronym / sponsor ID
- KEK-ZH-Nr. 2010-0330
- Conditions
- Healthy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 20 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy men and women between 18 and 65 years of age without gastrointestinal disease needing medical or surgical treatment.
- No medication (with the exception of occasional intake of paracetamol)
- Availability of all investigations (high resolution anorectal manometry, anorectal barostat with short and standard protocol, proctoscopy and endoanal ultrasound to assess sphincter morphology)
- Good communication with study doctor and meeting of all study requirements.
- Written consent after detailed explanation of study.
Key exclusion criteria (15 listed)
- Gastrointestinal symptoms especially fecal incontinence and obstructed defecation
- Structural or functional changes of upper and lower GI Tract (i.e gastric ulcer, malignancy , symptoms of IBS)
- Symptomatic or manometrically diagnosed motility disorders of the upper and lower GI tract for example anismus
- Surgery or interventions in the lower and upper GI tract (appendectomy and hernia excluded) included congenital malformations
- Pelvic radiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anorectal manometryAlso: AHRMHigh-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. | Device | – |
| barostatFor 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. | Device | – |
Primary outcome
Assessment of anorectal perception thresholds with short protocol barostat in healthy volunteers
Time frame: during hospital stay, estmated 0.5 days
1 secondary outcome
anorectal perception thresholds in % in relation to rectal capacity assessed in ml
Time frame: at time of hospital stay approx 0.5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Derived from this study: PubMed 24517865Sauter 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
Heiko Fruehauf, MD principal investigator
University Hospital Zurich, Division of Gastroenterology and Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing anorectal manometry and barostat in people with Healthy, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of anorectal perception thresholds with short protocol barostat in healthy volunteers (time frame: during hospital stay, estmated 0.5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01456442, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.