Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children

Constipation Clinical Trial

Official title:

Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812823
• Other study ID #: Banasiuk 2016A
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 2019

Study information

• Verified date: November 2018
• Source: Medical University of Warsaw
• Contact: Marcin Banasiuk, PhD
• Phone: +48223179463
• Email: mbanasiu[@]tlen.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.

The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.

Description:

Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Months to 18 Years

Eligibility

Inclusion Criteria:

• Functional Constipation

• Fecal Incontinence

• Parental Agreement

Exclusion Criteria:

• After surgery on lower gastrointestinal tract

• Diagnosis of inflammatory bowel disorders

• Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures

• Lack of parental agreement

Related Conditions & MeSH terms

• Children
• Constipation
• Fecal Incontinence
• Pathologic Processes

Intervention

Device:
• High-resolution anorectal manometry
Recording of conventional manometric parameters after insertion of the catheters.

Locations

Country	Name	City	State
Poland	Department of Pediatric Gastroenterology and Nutrition	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Medtronic

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in Resting pressure of the anorectal area	Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed.; The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated.	20 seconds
Secondary	Maximum squeeze pressure	Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).	1 min
Secondary	Bear down manoeuver	Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times)	1 min
Secondary	Thresholds of sensation	The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort.	1 min
Secondary	Recto anal inhibitory reflex	The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed.	5 min