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

NCT06924957 | Enrolling By Invitation

• 1 other identifier: Banasiuk2021B
• Study Type: observational
• Target: 120
• 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. 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.

Conditions

Constipation; Children; Anorectal Disorder

Keywords

anorectal manometry; HRAM; constipasion; position

Outcome Measures

Primary Outcomes (1)

• DD frequency

  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 Outcomes (3)

• Values of pressures obtained during anorectal manometry

  1 day

• Values of mean anal canal length

  1 day

• Percentage of anal relaxation rate

  1 day

Study Arms (2)

Constipation group

Children that meet Rome IV criteria to diagnose functional constipation.

Other: 3D HRAM

Healthy volounteers

Children without IBD, without chronic diseases of GI tract nor history of anorectal surgery

Other: 3D HRAM

Interventions

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.

Also known as: Three-dimensional high-resolution anorectal manometry

Constipation group; Healthy volounteers

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medtronic: collaborator

Study Sites (1)

The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University

Warsaw, Masovian Voivodeship, 02-091, Poland

Location

Related Publications (6)

• Rao SS, Kavlock R, Rao S. Influence of body position and stool characteristics on defecation in humans. Am J Gastroenterol. 2006 Dec;101(12):2790-6. doi: 10.1111/j.1572-0241.2006.00827.x. Epub 2006 Oct 6.

  PMID: 17026568 BACKGROUND

• Su H, Peng LH, Sun G, Yang YS, Wu J, Jiang GJ, Ge H. Effect of different body position on anorectal manometry for chronic constipation patients. Eur Rev Med Pharmacol Sci. 2019 Oct;23(19):8493-8500. doi: 10.26355/eurrev_201910_19162.

  PMID: 31646580 BACKGROUND

• Wu GJ, Xu F, Lin L, Pasricha PJ, Chen JDZ. Anorectal manometry: Should it be performed in a seated position? Neurogastroenterol Motil. 2017 May;29(5). doi: 10.1111/nmo.12997. Epub 2016 Dec 1.

  PMID: 27910245 BACKGROUND

• Coss-Adame E, Rao SS, Valestin J, Ali-Azamar A, Remes-Troche JM. Accuracy and Reproducibility of High-definition Anorectal Manometry and Pressure Topography Analyses in Healthy Subjects. Clin Gastroenterol Hepatol. 2015 Jun;13(6):1143-50.e1. doi: 10.1016/j.cgh.2014.12.034. Epub 2015 Jan 20.

  PMID: 25616028 BACKGROUND

• Grossi U, Carrington EV, Bharucha AE, Horrocks EJ, Scott SM, Knowles CH. Diagnostic accuracy study of anorectal manometry for diagnosis of dyssynergic defecation. Gut. 2016 Mar;65(3):447-55. doi: 10.1136/gutjnl-2014-308835. Epub 2015 Mar 12.

  PMID: 25765461 BACKGROUND

• Skowronska B, Banaszkiewicz A, Banasiuk M. Influence of body position on defecation mechanics measured during high-resolution anorectal manometry in paediatric population: a protocol for case-control study. BMJ Open. 2025 Dec 31;15(12):e112928. doi: 10.1136/bmjopen-2025-112928.

  PMID: 41475818 DERIVED

MeSH Terms

Conditions

Constipation; Rectal Diseases

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Barbara Skowrońska, MD

  Department of Pediatric Gastroenterology Medical University of Warsaw

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: April 13, 2025
• Study Start: January 10, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)