Anal Incontinence or ConstipationNCT01946334
Does Body Position Influence Pressure Recording by High-resolution Manometry ?
A study testing anorectal manometry and high-resolution three-dimensional in people with Anal Incontinence or Constipation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The anorectal manometry is the gold standard in the evaluation of anorectal function. Several techniques are currently used (balloons, perfused catheters) and are always performed in the supine position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Incontinence or Constipation
- What is being tested?
- anorectal manometry and high-resolution three-dimensional
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2013to Mar 2014
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman over the age of 18 years
- Patient referred for endoscopic ultrasound and anal manometry anorectal HR-3D which is an indication of fecal incontinence or dyschesia
Who cannot join
- Patient age 18 Less
- Patient trust, guardianship, judicial protection
- No Written Consent
- Lack of social insurance
- History of anorectal surgery
- A presence of anal stenosis
- A setting evidence of anorectal lesion preventing the realization of the Screening
- Motor disability preventing the realization of the anorectal manometry 3D HR-standing situation
Trial locations and contacts
1 site in 1 country.
About this study
The anorectal manometry is the gold standard in the evaluation of anorectal function.
Several techniques are currently used (balloons, perfused catheters) and are always performed in the supine position.
Read more
Few studies have reported the evaluation of sphincter function in the upright position, whereas symptoms of fecal incontinence occur in this position.
Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows topographic analysis and evaluation of anorectal function more acurate. In addition, the rigid nature of the probe should allow stability measures / recording, which is not possible with probes perfused catheters example.
We therefore propose to compare anal sphincter pressure in supine and standing, measured in high-resolution manometry.
- Conditions
- Anal Incontinence or Constipation
- Being tested
- anorectal manometry and high-resolution three-dimensional
- Medical subject headings
- Encopresis, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anorectal manometry and high-resolution three-dimensionalDevice
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Not described Receives: Device: anorectal manometry and high-resolution three-dimensional |
What is being measured
The primary outcome is the main question the study is designed to answer.
anal pressures measured by anorectal manometry and high-resolution three-dimensional
comparing two positions conventional position in the left lateral decubitus position with the feet.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal Incontinence or ConstipationStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LOIC MONDOLONI, Study director, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01946334
- Sponsor's protocol ID
- 2013-A00507-38
- Other IDs
- 2013-13
- Status last verified
- Aug 2014
- First submitted
- 11 Sep 2013
- Last updated
- 1 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Body Position Influence Pressure Recording by High-resolution Manometry ?
- ClinicalTrials.gov ID
- NCT01946334
- Acronym / sponsor ID
- 2013-A00507-38
- Conditions
- Anal Incontinence or Constipation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jun 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 19 Sep 2013 (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 anorectal manometry is the gold standard in the evaluation of anorectal function.
Several techniques are currently used (balloons, perfused catheters) and are always performed in the supine position.
Few studies have reported the evaluation of sphincter function in the upright position, whereas symptoms of fecal incontinence occur in this position.
Recently developed, high-resolution manometry, thanks to its many mechanical sensors, allows topographic analysis and evaluation of anorectal function more acurate. In addition, the rigid nature of the probe should allow stability measures / recording, which is not possible with probes perfused catheters example.
We therefore propose to compare anal sphincter pressure in supine and standing, measured in high-resolution manometry.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Device: anorectal manometry and high-resolution three-dimensional |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Man or woman over the age of 18 years
- Patient referred for endoscopic ultrasound and anal manometry anorectal HR-3D which is an indication of fecal incontinence or dyschesia
Key exclusion criteria (8 listed)
- Patient age 18 Less
- Patient trust, guardianship, judicial protection
- No Written Consent
- Lack of social insurance
- History of anorectal surgery
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 manometry and high-resolution three-dimensional | Device | patients |
Primary outcome
anal pressures measured by anorectal manometry and high-resolution three-dimensional
Time frame: 12 months
comparing two positions conventional position in the left lateral decubitus position with the feet.
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 1 Sep 2014.
Related trials for Anal Incontinence or Constipation
Not yet recruiting
Outcome Research in Bowel Irrigation Techniques for the Treatment of Chronic Constipation and/or Faecal Incontinence
Faecal Incontinence, Chronic Constipation
RecruitingPhase 1/2
Anorectal Manometery in Pediatric Chronic Refractory Constipation
Chronic Constipation
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.
LOIC MONDOLONI study director
Assistance Publique Hopitaux De Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anorectal manometry and high-resolution three-dimensional in people with Anal Incontinence or Constipation, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 inclusion and 8 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 1 Sep 2014. 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 France. 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.
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?
anal pressures measured by anorectal manometry and high-resolution three-dimensional (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Sep 2014.