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3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders

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ClinicalTrials.gov Identifier: NCT02296008
Recruitment Status : Completed
First Posted : November 20, 2014
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Marcin Banasiuk, Medical University of Warsaw

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Children Anorectal Disorder Anorectal Atresia Hirschsprung Disease Device: 3D high resolution anorectal manometry Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Actual Study Start Date : April 1, 2013
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016


Arm Intervention/treatment
surgery for Hirschsprung's disease
children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry

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.


surgery for anorectal malformation
children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry

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.


surgery for other disorders
children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry

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.





Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Presence of rectoanal inhibitory reflex [ Time Frame: 5 minutes ]
    Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex

  2. Presence of sphincteric lesion in 3D picture of anal canal [ Time Frame: 30 seconds ]
  3. Presence of ano-anal reflex [ Time Frame: 10 seconds ]
    an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors

  4. Presence of cough reflex [ Time Frame: 10 seconds ]
    an increase in pressure during cough will be recorded by the sensors

  5. Presence of discomfort during procedure [ Time Frame: 20 minutes ]
  6. Presence of dyssynergic defecation [ Time Frame: 2 minutes ]
    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



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Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • parental disagreement
  • children <12 months of age and >18 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02296008


Locations
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Poland
Department of Pediatric Gastroenterology and Nutrition
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
Medtronic - MITG
Investigators
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Principal Investigator: Marcin Banasiuk, MD Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland

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Responsible Party: Marcin Banasiuk, M.D., Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02296008     History of Changes
Other Study ID Numbers: Banasiuk2014 B
First Posted: November 20, 2014    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Keywords provided by Marcin Banasiuk, Medical University of Warsaw:
high resolution manometry
children
congenital anorectal disorder
surgery
Additional relevant MeSH terms:
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Hirschsprung Disease
Rectal Diseases
Anorectal Malformations
Disease
Pathologic Processes
Digestive System Abnormalities
Digestive System Diseases
Megacolon
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Congenital Abnormalities