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NCT Number: NCT06924957

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

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.

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Key information

Conditions

Constipation Anorectal Disorder Children Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Rectal Diseases Signs and Symptoms Signs and Symptoms, Digestive

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-091, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D HRAM

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Medtronic

Registry information

Official study title

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

Acronym: HRAMposition

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Apr 13, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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