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

NCT02812836 | Unknown

• 1 other identifier: Banasiuk 2016B
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Children; Constipation

Keywords

anorectal manometry; children; constipation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Bear down manoeuver pressure differential

  1 min

• puborectalis muscle pressure

  1 min

Study Arms (1)

Manometry

OTHER

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

Device: Manometry

Interventions

Manometry DEVICE

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.

Also known as: Balloon

Manometry

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Constipation
• Parental agreement

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medtronic: collaborator

Study Sites (1)

Department of Pediatric Gastroenterology and Nutrition

Warsaw, 02-091, Poland

RECRUITING

MeSH Terms

Conditions

Constipation

Interventions

Manometry

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Marcin Banasiuk, PhD

  Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcin Banasiuk, PhD

CONTACT

+48223179463; mbanasiu@tlen.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 24, 2016
• Study Start: March 1, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: November 14, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)