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3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children

3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02812836
Enrollment
100
Registered
2016-06-24
Start date
2018-03-01
Completion date
2019-03-01
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

Children, Constipation

Keywords

anorectal manometry, children, constipation

Brief summary

Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet obstruction. Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.

Detailed description

Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry and after the procedure BET will be performed at the same day. During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min. Data from manometry will be correlated with the success rate of BET.

Interventions

DEVICEManometry

Each patient will be investigated first by anorectal manometry, standard protocol of conventional parameters will be recorded such as: resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After that balloon with 50 ml of water will be inserted into the rectum and patient will be asked to expel the device within 1 min in privacy.

Sponsors

Medtronic
CollaboratorINDUSTRY
Medical University of Warsaw
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
5 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Constipation * Parental agreement

Exclusion criteria

* after surgery on lower gastrointestinal tract * diagnosis of inflammatory bowel disease * diagnosis of other disorder that may affect anorectum function * parental disagreement

Design outcomes

Primary

MeasureTime frameDescription
Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.30 minPercent of patients with the diagnosis of dyssynergic defecation made by BET and according to manometric equipment.

Secondary

MeasureTime frameDescription
Bear down manoeuver pressure differential1 minPressures of rectum and anal canal during bear down manoeuver will be recorded 3 times. Patients will be classified as dyssynergic defecation type. Correlation between the type and the result of BET will be evaluated.
puborectalis muscle pressure1 min3D picture of anal canal will be recorded and pressure of puborectalis muscle will be recorded during rest and squeeze. The level of pressure will be correlated with the result of BET

Countries

Poland

Contacts

Primary ContactMarcin Banasiuk, PhD
mbanasiu@tlen.pl+48223179463

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026