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

Not Applicable

• Conditions: Children; Constipation
• Interventions: Device: Manometry

• Registration Number: NCT02812836
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-22
• Study First Posted: 2016-06-24
• Study Start: 2018-03-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Manometry	Manometry	All patients will be investigated by anorectal manometry and after the procedure with balloon expulsion test as previously described.

Primary Outcome Measures

Name	Time	Method
Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.	30 min	Percent of patients with the diagnosis of dyssynergic defecation made by BET and according to manometric equipment.

Secondary Outcome Measures

Name	Time	Method
Bear down manoeuver pressure differential	1 min	Pressures 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 pressure	1 min	3D 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

Trial Locations

Locations (1)

Department of Pediatric Gastroenterology and Nutrition; 🇵🇱 Warsaw, Poland