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

Primary Purpose

Children, Constipation

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

Manometry

About this trial

This is an interventional diagnostic trial for Children focused on measuring anorectal manometry, children, constipation

Eligibility Criteria

5 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Pediatric Gastroenterology and NutritionRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Manometry

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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

Full Information

NCT ID

NCT02812836

First Posted

June 22, 2016

Last Updated

November 12, 2018

Sponsor

Medical University of Warsaw

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT02812836

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

March 1, 2019 (Anticipated)

Study Completion Date

March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Warsaw

Collaborators

Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Children, Constipation

Keywords

anorectal manometry, children, constipation

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Manometry

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Manometry

Other Intervention Name(s)

Balloon

Intervention Description

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.

Primary Outcome Measure Information:

Title

Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.

Description

Percent of patients with the diagnosis of dyssynergic defecation made by BET and according to manometric equipment.

Time Frame

30 min

Secondary Outcome Measure Information:

Title

Bear down manoeuver pressure differential

Description

Time Frame

1 min

Title

puborectalis muscle pressure

Description

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

Time Frame

1 min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcin Banasiuk, PhD

Phone

+48223179463

mbanasiu@tlen.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcin Banasiuk, PhD

Organizational Affiliation

Medical University of Warsaw

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pediatric Gastroenterology and Nutrition

City

Warsaw

ZIP/Postal Code

02-091

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcin Banasiuk, PhD

Phone

+48223179463

mbanasiu@tlen.pl

First Name & Middle Initial & Last Name & Degree

Marcin Banasiuk, PhD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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