Influence of Body Position on the Defecation Model During Anorectal Manometry. (HRAMposition)

August 17, 2026 updated by: Marcin Banasiuk, Medical University of Warsaw

Influence of Body Position on the Defecation Model Measured During High Resolution Anorectal Manometry in Children- a Control Study.

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. Resent studies suggest that the position in which 3D HRAM is performed should be changed. So far, no scientific research has been performed in children that directly compares both positions. The reference values of registered pressures during 3D HRAM in people without complaints were not specified, which would allow for a more precise diagnosis of patients with an incorrect defecation model and precise selection of patients who could benefit from biofeedback therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry in both- sitted and lying position.

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.

Study Type

Observational

Enrollment (Actual)

84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-091
        • The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The sample size was calculated to detect a 45% difference in the percentage of patients with a negative rectoanal gradient, assuming equal groups, alpha = 0.05, beta = 0.1, and a 30% drop out percentage. There should be 30 people in the constipation group and 30 healthy volunteers.

Due to possible differences depending on age, it was decided to conduct the study in two separate age groups (I. younger, i.e. 5-10 years old and II. older, 11-18 years old). The total number of patients in the study will therefore be 120 people.

Description

Inclusion criteria - the study group:

  • age from 5 to 18 years old
  • functional constipation diagnosed on the basis of Rome IV criteria
  • parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent

Inclusion criteria - the control group:

  • age from 5 to 18 years old
  • no lower gastrointestinal symptoms
  • parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent

Exclusion criteria - the study group and the control group:

  • undergone surgeries due to congenital anomalies in the lower gastrointestinal tract
  • inflammatory bowel diseases or inflammation of the large intestine with a different aetiology
  • anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Constipation group
Children that meet Rome IV criteria to diagnose functional constipation.
Other: 3D HRAM
The test will be performed both in supine and sitting position successively, using 3D HR-ARM. Resting, squeeze pressures, and bear down manoeuvre variables will be obtained. Diagnosis of dyssynergic defecation requires < 20% relaxation of anal sphincter and/or intrarectal pressure>40 mmHg during bear down manoeuvre.
Other Names:
  • Three-dimensional high-resolution anorectal manometry
Healthy volounteers
Children without IBD, without chronic diseases of GI tract nor history of anorectal surgery
Other: 3D HRAM
The test will be performed both in supine and sitting position successively, using 3D HR-ARM. Resting, squeeze pressures, and bear down manoeuvre variables will be obtained. Diagnosis of dyssynergic defecation requires < 20% relaxation of anal sphincter and/or intrarectal pressure>40 mmHg during bear down manoeuvre.
Other Names:
  • Three-dimensional high-resolution anorectal manometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DD frequency
Time Frame: 1 day
The difference in the number of patients with DD (defined as <20% relaxation of anal sphincter and/or intrarectal pressure >40 mmHg during bear down manoeuvre) in sitting and lying position.
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Values of pressures obtained during anorectal manometry
Time Frame: 1 day
Values of manometric parameters obtained in the lying and sitting position: mean resting pressure of the anal sphincter (mmHg), maximum squeeze pressure (mmHg), residual anal pressure (mmHg).
1 day
Values of mean anal canal length
Time Frame: 1 day
The mean anal canal length will be assessed in sitting and lying position in the two groups.
1 day
Percentage of anal relaxation rate
Time Frame: 1 day

the assessment of parameters of defecation dynamics during HR-ARM: rectoanal pressure gradient. All secondary end points will be assessed in sitting and lying position in the two groups.

the assessment of parameters of defecation dynamics during HR-ARM: percentage of anal relaxation rate, rectoanal pressure gradient. All secondary
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Medtronic

Investigators

  • Principal Investigator: Barbara Skowrońska, MD, Department of Pediatric Gastroenterology Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2020

Primary Completion (Actual)

August 17, 2026

Study Completion (Actual)

August 17, 2026

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 13, 2025

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Banasiuk2021B

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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