ChildrenNCT02296008
3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
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
3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal. Until now, it has been used only in adult population to evaluate defecatory disorders. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Children, Anorectal Disorder, Anorectal Atresia
- 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
- 43 participants
- Where
- 1 sitePoland
- Study dates
- 1 Apr 2013to 31 Dec 2016
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- age:1-18 yr
- after surgery for Hirschsprung's disease,
- after surgery for Anorectal malformations,
- after total procto/colectomy
- with parental agreement for the procedure
Who cannot join
- parental disagreement
- children <12 months of age and >18 years
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Pediatric Gastroenterology and Nutrition
Warsaw, 01-184
About this study
3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.
Until now, it has been used only in adult population to evaluate defecatory disorders.
Read more
Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.
The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.
It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.
Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.
- Conditions
- Children, Anorectal Disorder, Anorectal Atresia, Hirschsprung Disease
- Being tested
- 3D high resolution anorectal manometry
- Keywords
- high resolution manometry, children, congenital anorectal disorder, surgery
- Medical subject headings
- Rectal Diseases, Anorectal Malformations, Hirschsprung Disease
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 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible.
3D picture of pressures of anorectal will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| surgery for Hirschsprung's disease | Other | children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure Receives: Device: 3D high resolution anorectal manometry |
| surgery for anorectal malformation | Other | children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure Receives: Device: 3D high resolution anorectal manometry |
| surgery for other disorders | Other | children after surgery for other disorders will undergo 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 will be recorded in mmHg
Measured: 20 minutes
Secondary outcomes (6)
Presence of rectoanal inhibitory reflex
Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex
Measured: 5 minutes
Presence of sphincteric lesion in 3D picture of anal canal
Measured: 30 seconds
Presence of ano-anal reflex
an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors
Measured: 10 seconds
Presence of cough reflex
an increase in pressure during cough will be recorded by the sensors
Measured: 10 seconds
Presence of discomfort during procedure
Measured: 20 minutes
Presence of dyssynergic defecation
during bear down maneuver lasting 20 second and repeated 2 times with the resting period of 1 minute the configuration of pressures inside the rectum and anal canal will be recorded and analyzed according to the criteria of dyssynergic defecation
Measured: 2 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2014 (estimated)
- Study start1 Apr 2013
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 43 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, Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02296008
- Sponsor's protocol ID
- Banasiuk2014 B
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2014
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Banasiuk M, Dziekiewicz M, Dembinski L, Piotrowski D, Kaminski A, Banaszkiewicz A. Three-dimensional high-resolution anorectal manometry in children after surgery for anorectal disorders. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2981-2993. doi: 10.26355/eurrev_202104_25551.
PubMed 33877661
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
- 3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
- ClinicalTrials.gov ID
- NCT02296008
- Acronym / sponsor ID
- Banasiuk2014 B
- Conditions
- Children, Anorectal Disorder, Anorectal Atresia, Hirschsprung Disease
- Keywords
- high resolution manometry, children, congenital anorectal disorder, surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- 1 Apr 2013 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 20 Nov 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.
3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.
Until now, it has been used only in adult population to evaluate defecatory disorders.
Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.
The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.
It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.
Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| surgery for Hirschsprung's disease | Other | Device: 3D high resolution anorectal manometrychildren after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure |
| surgery for anorectal malformation | Other | Device: 3D high resolution anorectal manometrychildren after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure |
| surgery for other disorders | Other | Device: 3D high resolution anorectal manometrychildren after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- age:1-18 yr
- after surgery for Hirschsprung's disease,
- after surgery for Anorectal malformations,
- after total procto/colectomy
- with parental agreement for the procedure
Key exclusion criteria (2 listed)
- parental disagreement
- children <12 months of age and >18 years
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 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible. 3D picture of pressures of anorectal will be recorded. | Device | surgery for Hirschsprung's disease, surgery for anorectal malformation, surgery for other disorders |
Primary outcome
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
Time frame: 20 minutes
pressures will be recorded in mmHg
6 secondary outcomes
Presence of rectoanal inhibitory reflex
Time frame: 5 minutes
Presence of sphincteric lesion in 3D picture of anal canal
Time frame: 30 seconds
Presence of ano-anal reflex
Time frame: 10 seconds
Presence of cough reflex
Time frame: 10 seconds
Presence of discomfort during procedure
Time frame: 20 minutes
Presence of dyssynergic defecation
Time frame: 2 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 14 Nov 2018.
- Derived from this study: PubMed 33877661Banasiuk M, Dziekiewicz M, Dembinski L, Piotrowski D, Kaminski A, Banaszkiewicz A. Three-dimensional high-resolution anorectal manometry in children after surgery for anorectal disorders. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2981-2993. doi: 10.26355/eurrev_202104_25551.
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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
Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland
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 5 inclusion and 2 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 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?
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: 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 NCT02296008, 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.