Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-03 @ 9:50 AM
Study NCT ID:
NCT07291661
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-18
First Post:
2025-11-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}, {'id': 'D005242', 'term': 'Fecal Incontinence'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A descriptive cross-sectional study'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-05', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-12-05', 'lastUpdatePostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of anorectal manometry abnormalities in children with chronic refractory constipation, with or without fecal incontinence.', 'timeFrame': 'Baseline', 'description': 'We will measure resting anal pressure, squeeze pressure, changes in rectoanal pressure during cough and during stimulated defecation, rectoanal inhibitory reflex (RAIR), and rectal sensation thresholds (first sensation, urge, maximum tolerable volume) using High resolusion anorectal manometry(HRAM) .\n\nAbnormalities will be categorized as:\n\n* Impaired or absent RAIR\n* Abnormal resting or squeeze sphincter pressure (outside age-adjusted norms)\n* Rectal sensory dysfunction (hyposensitivity or hypersensitivity)\n* Presence of dyssynergic defecation. And will be reported as counts and percentages.'}], 'secondaryOutcomes': [{'measure': 'Guiding Management of Chronic Refractory Constipation in Children Using Anorectal Manometry Findings.', 'timeFrame': 'Baseline', 'description': 'Classification of anorectal manometry patterns-including dyssynergic defecation, rectal hyposensitivity, and elevated resting anal sphincter pressure-and documentation of the number of participants assigned to different management strategies including (biofeedback therapy, botulinum toxin injection) according to these findings.\n\nPatients with manometry parameters showing dyssennergic defecation or rectal hyposensitivity will receive biofeedback sessions. While Participants with manometry parameters showing high anal canal resting pressure will have botulinium toxin injections.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anorectal manometry', 'Functional constipation', 'Pediatric chronic refractory constipation', 'Fecal incontinence', 'Biofeedback therapy', 'Botox injection'], 'conditions': ['Refractory Constipation', 'Fecal Incontinence in Children']}, 'referencesModule': {'references': [{'pmid': '34270377', 'type': 'BACKGROUND', 'citation': 'Poojari VS, Mirani S, Shetty NS, Shah I. Evaluation of constipation in children using high-resolution anorectal manometry. Trop Doct. 2021 Oct;51(4):527-531. doi: 10.1177/00494755211030362. Epub 2021 Jul 16.'}, {'pmid': '32692116', 'type': 'BACKGROUND', 'citation': 'Rao SSC, Tetangco EP. Anorectal Disorders: An Update. J Clin Gastroenterol. 2020 Aug;54(7):606-613. doi: 10.1097/MCG.0000000000001348.'}, {'pmid': '29636555', 'type': 'BACKGROUND', 'citation': 'Carrington EV, Scott SM, Bharucha A, Mion F, Remes-Troche JM, Malcolm A, Heinrich H, Fox M, Rao SS; International Anorectal Physiology Working Group and the International Working Group for Disorders of Gastrointestinal Motility and Function. Expert consensus document: Advances in the evaluation of anorectal function. Nat Rev Gastroenterol Hepatol. 2018 May;15(5):309-323. doi: 10.1038/nrgastro.2018.27. Epub 2018 Apr 11.'}, {'pmid': '29656863', 'type': 'BACKGROUND', 'citation': 'Koppen IJN, Vriesman MH, Saps M, Rajindrajith S, Shi X, van Etten-Jamaludin FS, Di Lorenzo C, Benninga MA, Tabbers MM. Prevalence of Functional Defecation Disorders in Children: A Systematic Review and Meta-Analysis. J Pediatr. 2018 Jul;198:121-130.e6. doi: 10.1016/j.jpeds.2018.02.029. Epub 2018 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'This research protocol outlines a two-year descriptive cross-sectional study to investigate the role of high-resolution anorectal manometry (HRAM) in children aged 4-18 years with chronic refractory constipation.The study plans to enroll 54 patients at Ain Shams University Specialized Hospital . The study aims to identify different patterns of anorectal dysfunction (like dyssynergic defecation or rectal hyposensitivity) using standardized international protocols. A key goal is to determine if these manometry findings can directly guide specific management strategies, such as biofeedback therapy for dyssynergia or botulinum toxin injections for anal hypertension. improving outcomes for children who do not respond to standard constipation therapies.', 'detailedDescription': 'Structural and functional abnormalities of the anorectum or pelvic floor have been observed in constipated children with or without fecal incontinence. Childhood functional constipation accounts for about 95% of cases, while organic causes are less than 5%.\n\nOrganic causes include Hirschsprung disease, anorectal malformations, neuromuscular disorders and metabolic causes. Functional constipation can be caused by paradoxical contraction or insufficient relaxation of the pelvic floor muscles, and/or inadequate rectal propulsive forces during defecation. According to the Rome IV criteria, functional constipation is defined separately for infants and toddlers (\\<4 years) and for children (≥ 4 years).\n\nAnorectal manometry (ARM) is an objective tool used to measure pressure and sensation in the anorectum at rest, during squeezing, and during simulated evacuation. three dimensional high resolution anorectal manometry (3D-HRAM) employs an array of 256 sensors, offering a more detailed assessment of anorectal anatomy and function.\n\nAnorectal manometry is used for the evaluation of chronic constipation by checking rectoanal coordination and rectal sensitivity, and helps exclude structural disorders. It evaluates fecal incontinence by analyzing sphincter function and rectal sensation, identifies sphincter hypertension in functional anorectal pain, and provides preoperative baseline data before surgeries affecting continence or defecation.\n\nTreatment of childhood constipation includes both nonpharmacological approaches (education, dietary modifications, behavioral strategies, biofeedback, and pelvic floor physiotherapy) and pharmacological options (osmotic and stimulant laxatives, probiotics as well as newer medications such as prucalopride and lubiprostone). For children with persistent constipation transanal irrigation, botulinum toxin injections, neuromodulation, and surgical procedures may be considered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children and adolescents aged from 4 to 18 years.\n2. Participants who have chronic refractory constipation either functional or organic with or without fecal incontinence.\n3. Cooperative patients.\n\nExclusion Criteria:\n\n1. Children aged less than 4 years old.\n2. Uncooperative patients.\n3. Children with anal fissures or any painful conditions that interfere with the procedure.'}, 'identificationModule': {'nctId': 'NCT07291661', 'briefTitle': 'The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The Role of Anorectal Manometry in Diagnosing and Guiding Management of Pediatric Chronic Refractory Constipation', 'orgStudyIdInfo': {'id': 'Anorectal manometry'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High resolution anorectal manometry using multiuse water perfused catheter', 'description': 'Solar™ GI High Resolution Anorectal Manometry with multiuse water perfused catheter', 'interventionNames': ['Device: High resolution anorectal manometry using a multiuse water perfused catheter']}], 'interventions': [{'name': 'High resolution anorectal manometry using a multiuse water perfused catheter', 'type': 'DEVICE', 'description': 'According to the international anorectal physiology working group recommendations(8):\n\nStabilization: A 3-minute period after catheter insertion to allow anal tone to return to baseline.\n\n* Rest: Measures basal anal tone over 60 seconds.\n* Squeeze: Records anal pressure during voluntary contraction. Three 5-second squeezes are performed.\n* Long Squeeze: Evaluates anal pressure and fatigue during a single sustained 30-second contraction.\n* Cough: Assesses reflex anal pressure changes during two single coughs.\n* Push: Measures pressure changes during simulated defecation. Three 15-second pushes are performed.\n* RAIR (Rectoanal Inhibitory Reflex): Tests reflex anal relaxation after rapid rectal balloon distension, starting with at least 30 mL.\n\nRectal Sensory Test: Measures rectal sensitivity by recording balloon volumes at three thresholds: first constant sensation, desire to defecate, and maximum tolerated volumes.\n\n· Balloon Expulsion: time required to expel the balloon.', 'armGroupLabels': ['High resolution anorectal manometry using multiuse water perfused catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut University-faculty of medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Yasser M. Abd Elaal, Master', 'role': 'CONTACT', 'email': 'Yasser.mohamed412@gmail.com', 'phone': '+201021356722'}, {'name': 'Nagla H. Ibrahim, Professor', 'role': 'CONTACT', 'phone': '+20111187223'}], 'overallOfficials': [{'name': 'Naglaa H. Ibrahim, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assiut University- Faculty of medicine'}, {'name': 'Naglaa S. Mohamed, A. professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University- Faculty of medicine'}, {'name': 'Rehab I. Hassan, Lecturer', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University- Faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Yasser Mohamed Abd Elaal Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}