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

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.

Study Overview

• Status: Unknown
• Conditions: Constipation; Children
• Intervention / Treatment: Device: Manometry

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 02-091
    • Recruiting
    • Department of Pediatric Gastroenterology and Nutrition
    • Contact: Marcin Banasiuk, PhD; Phone Number: +48223179463; Email: mbanasiu@tlen.pl
    • Principal Investigator: Marcin Banasiuk, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 14 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Manometry; All patients will be investigated by anorectal manometry and after the procedure with balloon expulsion test as previously described.

Device: Manometry; 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.; Other Names: Balloon

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bear down manoeuver pressure differential	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.	1 min
puborectalis muscle pressure	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	1 min

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Collaborators: Medtronic
• Investigators: Principal Investigator: Marcin Banasiuk, PhD, Medical University of Warsaw

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: June 22, 2016
• First Submitted That Met QC Criteria: June 22, 2016
• First Posted (Estimate): June 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2018
• Last Update Submitted That Met QC Criteria: November 12, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: children; constipation; anorectal manometry
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation
• Other Study ID Numbers: Banasiuk 2016B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No