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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02812836
• Other study ID #: Banasiuk 2016B
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2018
• Est. completion date: March 1, 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

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Constipation

Intervention

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.

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	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	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
Secondary	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