Clinical trial NCT06924957: Influence of Body Position on the Defecation Model During Anorectal Manometry.
Official title: Influence of Body Position on the Defecation Model Measured During High Resolution Anorectal Manometry in Children- a Control Study.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Constipation
Children
Anorectal Disorder
Keywords: anorectal manometry
HRAM
constipasion
position
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2025-04-13
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: DD frequency
timeFrame: 1 day
Secondary outcomes:
measure: Values of pressures obtained during anorectal manometry
timeFrame: 1 day
measure: Values of mean anal canal length
timeFrame: 1 day
measure: Percentage of anal relaxation rate
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University
state: Mazowieckie
Study officials:
affiliation: Department of Pediatric Gastroenterology Medical University of Warsaw
name: Barbara Skowrońska, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.