ConstipationNCT02812823
Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children
A study testing High-resolution anorectal manometry in people with Constipation and Children, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum. The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most… Read more about this study
- Who is it for?
- Ages 4 months to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Constipation, Children, Fecal Incontinence
- What is being tested?
- High-resolution anorectal manometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Mar 2018to Mar 2019
- 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 4 months to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Functional Constipation
- Fecal Incontinence
- Parental Agreement
Who cannot join
- After surgery on lower gastrointestinal tract
- Diagnosis of inflammatory bowel disorders
- Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures
- Lack of parental agreement
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Department of Pediatric Gastroenterology and Nutrition
Warsaw, 02-091
Marcin Banasiuk, PhD, +48223179463, mbanasiu@tlen.pl
Marcin Banasiuk, PhD
About this study
Official title: Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.
The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.
Read the detailed description
Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.
- Conditions
- Constipation, Children, Fecal Incontinence
- Being tested
- High-resolution anorectal manometry
- Keywords
- manometry, children, constipation, functional disorders
- Medical subject headings
- Constipation, Fecal Incontinence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution anorectal manometryDevice
Recording of conventional manometric parameters after insertion of the catheters.
| Study group | Role | What they receive |
|---|---|---|
| High resolution anorectal manometry | Other | All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum. Receives: Device: High-resolution anorectal manometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in Resting pressure of the anorectal area
Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed.
The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated.
Measured: 20 seconds
Secondary outcomes (4)
Maximum squeeze pressure
Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).
Measured: 1 min
Bear down manoeuver
Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times)
Measured: 1 min
Thresholds of sensation
The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort.
Measured: 1 min
Recto anal inhibitory reflex
The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed.
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study start1 Mar 2018
- Primary completionMar 2019 (estimated)
- Study completionMar 2019 (estimated)
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 ConstipationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Marcin Banasiuk, Medical University of Warsaw
- Investigators
- Marcin Banasiuk, PhD, Principal investigator, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02812823
- Sponsor's protocol ID
- Banasiuk 2016A
- Status last verified
- Nov 2018
- First submitted
- 22 Jun 2016
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banasiuk M, Dobrowolska ME, Skowronska B, Konys J, Banaszkiewicz A. Comparison of Anorectal Function as Measured with High-Resolution and High-Definition Anorectal Manometry. Dig Dis. 2022;40(4):448-457. doi: 10.1159/000518357. Epub 2021 Aug 10.
PubMed 34515101
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children
- ClinicalTrials.gov ID
- NCT02812823
- Acronym / sponsor ID
- Banasiuk 2016A
- Conditions
- Constipation, Children, Fecal Incontinence
- Keywords
- manometry, children, constipation, functional disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 24 Jun 2016 (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.
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.
The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.
Detailed description
Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High resolution anorectal manometry | Other | Device: High-resolution anorectal manometryAll subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum. |
Who may qualify
- Ages
- 4 months to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Functional Constipation
- Fecal Incontinence
- Parental Agreement
Key exclusion criteria (4 listed)
- After surgery on lower gastrointestinal tract
- Diagnosis of inflammatory bowel disorders
- Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures
- Lack of parental agreement
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 |
|---|---|---|
| High-resolution anorectal manometryRecording of conventional manometric parameters after insertion of the catheters. | Device | High resolution anorectal manometry |
Primary outcome
Difference in Resting pressure of the anorectal area
Time frame: 20 seconds
Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed. The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated.
4 secondary outcomes
Maximum squeeze pressure
Time frame: 1 min
Bear down manoeuver
Time frame: 1 min
Thresholds of sensation
Time frame: 1 min
Recto anal inhibitory reflex
Time frame: 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Derived from this study: PubMed 34515101Banasiuk M, Dobrowolska ME, Skowronska B, Konys J, Banaszkiewicz A. Comparison of Anorectal Function as Measured with High-Resolution and High-Definition Anorectal Manometry. Dig Dis. 2022;40(4):448-457. doi: 10.1159/000518357. Epub 2021 Aug 10.
- Individual participant dataSharing planned: No
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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, PhD 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 High-resolution anorectal manometry in people with Constipation and Children, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 14 Nov 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcin Banasiuk, PhD (+48223179463, mbanasiu@tlen.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in Resting pressure of the anorectal area (time frame: 20 seconds). 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 NCT02812823, 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 2018.