ChildrenNCT02236507
Normal Values for 3D High Resolution Anorectal Manometry in Children
A study testing 3D high resolution anorectal manometry in people with Children and Anorectal Disorder, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal… Read more about this study
- Who is it for?
- Ages 12 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Children, Anorectal Disorder
- What is being tested?
- 3D high resolution anorectal manometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 sitePoland
- Study dates
- Apr 2013to Nov 2015
- 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 12 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- parental agreement
- age: 1 to 18 yr
Who cannot join
- parental disagreement
- children younger than 1 yr
- children after the surgery for anorectal malformations
- children with constipation during the last 10 months
- children with nonretentive fecal soiling
- children with inflammatory bowel diseases or any other type of large bowel inflammation
- children with anal fissure, anal varices, inflammation of the anorectal area or any other disease that may interfere with function of anorectum
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatric Gastroenterology and Nutrition
Warsaw, 01-184
About this study
Official title: Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.
Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established.
The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.
- Conditions
- Children, Anorectal Disorder
- Being tested
- 3D high resolution anorectal manometry
- Medical subject headings
- Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D high resolution anorectal manometryDevice
Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.
| Study group | Role | What they receive |
|---|---|---|
| children without anorectal disorders | Other | All children will be investigated by 3D high resolution anorectal manometry procedure Receives: Device: 3D high resolution anorectal manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal
Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
Measured: up to 20 minutes
Secondary outcomes (5)
Presence of Rectoanal Inhibitory Reflex
Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
Measured: up to 5 minutes
Presence of dyssynergic defecation
Percent of children without constipation but with dyssynergic defecation pattern
Measured: up to 1 minute
Presence of Cough Reflex
Measured: 10 seconds
Presence of Ano-anal Reflex
Measured: 10 seconds
Presence of discomfort during the procedure
Measured: up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionNov 2015
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 ChildrenStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, Marcin Banasiuk, Medical University of Warsaw
- Investigators
- Marcin Banasiuk, MD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236507
- Sponsor's protocol ID
- Banasiuk2014 A
- Status last verified
- Dec 2015
- First submitted
- 31 Aug 2014
- Last updated
- 23 Dec 2015
- Results posted
- No
Publications
Banasiuk M, Banaszkiewicz A, Dziekiewicz M, Zaleski A, Albrecht P. Values From Three-dimensional High-resolution Anorectal Manometry Analysis of Children Without Lower Gastrointestinal Symptoms. Clin Gastroenterol Hepatol. 2016 Jul;14(7):993-1000.e3. doi: 10.1016/j.cgh.2016.01.008. Epub 2016 Jan 25.
PubMed 26820403
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.
- ClinicalTrials.gov ID
- NCT02236507
- Acronym / sponsor ID
- Banasiuk2014 A
- Conditions
- Children, Anorectal Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 10 Sep 2014 (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.
Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established.
The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| children without anorectal disorders | Other | Device: 3D high resolution anorectal manometryAll children will be investigated by 3D high resolution anorectal manometry procedure |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- parental agreement
- age: 1 to 18 yr
Key exclusion criteria (7 listed)
- parental disagreement
- children younger than 1 yr
- children after the surgery for anorectal malformations
- children with constipation during the last 10 months
- children with nonretentive fecal soiling
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 |
|---|---|---|
| 3D high resolution anorectal manometryProcedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible. | Device | children without anorectal disorders |
Primary outcome
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal
Time frame: up to 20 minutes
Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
5 secondary outcomes
Presence of Rectoanal Inhibitory Reflex
Time frame: up to 5 minutes
Presence of dyssynergic defecation
Time frame: up to 1 minute
Presence of Cough Reflex
Time frame: 10 seconds
Presence of Ano-anal Reflex
Time frame: 10 seconds
Presence of discomfort during the procedure
Time frame: up to 20 minutes
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 23 Dec 2015.
- Derived from this study: PubMed 26820403Banasiuk M, Banaszkiewicz A, Dziekiewicz M, Zaleski A, Albrecht P. Values From Three-dimensional High-resolution Anorectal Manometry Analysis of Children Without Lower Gastrointestinal Symptoms. Clin Gastroenterol Hepatol. 2016 Jul;14(7):993-1000.e3. doi: 10.1016/j.cgh.2016.01.008. Epub 2016 Jan 25.
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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.
Marcin Banasiuk, MD principal investigator
Medical University of Warsaw
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D high resolution anorectal manometry in people with Children and Anorectal Disorder, run by Medical University of Warsaw at 1 site in Poland.
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 7 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 23 Dec 2015. 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 Poland. 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?
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal (time frame: up to 20 minutes). 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 NCT02236507, 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 23 Dec 2015.