Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02296008
Enrollment
43
Registered
2014-11-20
Start date
2013-04-01
Completion date
2016-12-31
Last updated
2018-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anorectal Atresia, Anorectal Disorder, Children, Hirschsprung Disease

Keywords

high resolution manometry, children, congenital anorectal disorder, surgery

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.

Interventions

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.

Sponsors

Medtronic - MITG
CollaboratorINDUSTRY
Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
12 Months to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal20 minutespressures will be recorded in mmHg

Secondary

MeasureTime frameDescription
Presence of sphincteric lesion in 3D picture of anal canal30 seconds
Presence of ano-anal reflex10 secondsan increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors
Presence of rectoanal inhibitory reflex5 minutesAmount of air inside the balloon needed to elicit rectoanal inhibitory reflex
Presence of discomfort during procedure20 minutes
Presence of dyssynergic defecation2 minutesduring 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
Presence of cough reflex10 secondsan increase in pressure during cough will be recorded by the sensors

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026