Ignite Creation Date:
2025-12-24 @ 7:01 PM
Ignite Modification Date:
2025-12-29 @ 9:51 PM
Study NCT ID:
NCT06924957
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-18
First Post:
2024-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Body Position on the Defecation Model During Anorectal Manometry.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D012002', 'term': 'Rectal Diseases'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-01', 'size': 234866, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-11-15T14:10', 'hasProtocol': True}, {'date': '2019-11-19', 'size': 128449, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-11-15T14:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2024-11-12', 'studyFirstSubmitQcDate': '2025-04-09', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DD frequency', 'timeFrame': '1 day', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Values of pressures obtained during anorectal manometry', 'timeFrame': '1 day', 'description': '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).'}, {'measure': 'Values of mean anal canal length', 'timeFrame': '1 day', 'description': 'The mean anal canal length will be assessed in sitting and lying position in the two groups.'}, {'measure': 'Percentage of anal relaxation rate', 'timeFrame': '1 day', 'description': '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.\n\nthe assessment of parameters of defecation dynamics during HR-ARM: percentage of anal relaxation rate, rectoanal pressure gradient. All secondary'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anorectal manometry', 'HRAM', 'constipasion', 'position'], 'conditions': ['Constipation', 'Children', 'Anorectal Disorder']}, 'referencesModule': {'references': [{'pmid': '17026568', 'type': 'BACKGROUND', '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.'}, {'pmid': '31646580', 'type': 'BACKGROUND', '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.'}, {'pmid': '27910245', 'type': 'BACKGROUND', '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.'}, {'pmid': '25616028', 'type': 'BACKGROUND', '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.'}, {'pmid': '25765461', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nDue 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.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria - the study group:\n\n* age from 5 to 18 years old\n* functional constipation diagnosed on the basis of Rome IV criteria\n* 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\n\nInclusion criteria - the control group:\n\n* age from 5 to 18 years old\n* no lower gastrointestinal symptoms\n* 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\n\nExclusion criteria - the study group and the control group:\n\n* undergone surgeries due to congenital anomalies in the lower gastrointestinal tract\n* inflammatory bowel diseases or inflammation of the large intestine with a different aetiology\n* 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"}, 'identificationModule': {'nctId': 'NCT06924957', 'acronym': 'HRAMposition', 'briefTitle': 'Influence of Body Position on the Defecation Model During Anorectal Manometry.', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'Influence of Body Position on the Defecation Model Measured During High Resolution Anorectal Manometry in Children- a Control Study.', 'orgStudyIdInfo': {'id': 'Banasiuk2021B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Constipation group', 'description': 'Children that meet Rome IV criteria to diagnose functional constipation.', 'interventionNames': ['Other: 3D HRAM']}, {'label': 'Healthy volounteers', 'description': 'Children without IBD, without chronic diseases of GI tract nor history of anorectal surgery', 'interventionNames': ['Other: 3D HRAM']}], 'interventions': [{'name': '3D HRAM', 'type': 'OTHER', 'otherNames': ['Three-dimensional high-resolution anorectal manometry'], 'description': '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.', 'armGroupLabels': ['Constipation group', 'Healthy volounteers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02-091', 'city': 'Warsaw', 'state': 'Masovian Voivodeship', 'country': 'Poland', 'facility': 'The Department of Paediatric Gastroenterology and Nutrition, Warsaw Medical University', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Barbara Skowrońska, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatric Gastroenterology Medical University of Warsaw'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Marcin Banasiuk', 'investigatorAffiliation': 'Medical University of Warsaw'}}}}