Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-01-09 @ 6:52 AM
Study NCT ID:
NCT04957667
Status:
COMPLETED
Last Update Posted:
2022-11-09
First Post:
2021-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006627', 'term': 'Hirschsprung Disease'}], 'ancestors': [{'id': 'D004065', 'term': 'Digestive System Abnormalities'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008531', 'term': 'Megacolon'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2021-05-31', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evacuation fraction (%) of radioactive material between first, second and third round of scintigraphic imaging', 'timeFrame': 'Day 1', 'description': 'The fraction of evacuated radioactive material by defecation between rounds of scintigraphic imaging'}, {'measure': 'Presence of retrograde movement of radioactive material (yes/no)', 'timeFrame': 'Day 1', 'description': 'Presence of retrograde movement of radioactive material within the bowel on scintigraphic images between rounds of scintigraphic imaging'}, {'measure': 'Hirschsprung and Anorectal Malformations Quality of life Questionnaire sub scales and total score', 'timeFrame': 'Day 1', 'description': 'Disease specific questionnaire including sub scales for laxative and constipating diet, presence of diarrhoea and constipation, faecal and urinary incontinence, social and emotional functioning, body image, physical symptoms and sexual functioning. Each item is phrased as a multiple-choice question with four response options; never, once in a while, often and very often. Responses are linearly transformed on a 0-100 scale with a higher score indicating better QOL.'}, {'measure': 'Type of surgical intervention performed in each individual (for example pull-through surgery)', 'timeFrame': 'Day 1', 'description': "Type of surgical intervention performed to treat Hirschsprung's disease"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hirschsprung disease', 'Scintigraphic defecography'], 'conditions': ['Hirschsprung Disease']}, 'descriptionModule': {'briefSummary': "This study aims to investigate long term outcomes of surgical intervention for Hirschsprung's disease and to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire.", 'detailedDescription': "Hirschsprung's disease (HD) is a congenital deficiency with incomplete development of nerves in the gastrointestinal tract leading to absence of peristalsis in the affected segment of bowel. Most patients require surgical intervention with removal of the affected segment of bowel. Physical symptoms affecting quality of life are not uncommon in patients born with HD in spite of surgical intervention. This renders a need for a tool for evaluating the functional outcome in these patients.\n\nScintigraphic defecography examines the defecation in terms of the ability to empty the bowel and examines the relocation of faeces within the bowel in relation to defecation.\n\nThis study aims to explore the relation between scintigraphic defecography, type of surgery performed and symptoms as evaluated by a disease specific questionnaire (Hirschsprung and Anorectal Malformations Quality of Life Questionnaire)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients operated for Hirschsprung's disease from 1985-2014 are gathered in a cohort, intended for several studies on Hirschsprung's disease. All patients \\> 15 years from this cohort will be invited to participate in this study.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients operated with any type of surgery for Hirschsprung's disease between 1985-2014\n* Age \\> 15 years\n\nExclusion Criteria:\n\n* Unable to understand given instructions in relation to the defecography (ex. retarded)\n* Pregnancy\n* Missing consent"}, 'identificationModule': {'nctId': 'NCT04957667', 'briefTitle': 'Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Scintigraphic Defecography for Evaluation of Functional Outcome in an Adult Hirschsprung Population', 'orgStudyIdInfo': {'id': 'HD-NQ-2018'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'state': 'Region Syddanmark', 'country': 'Denmark', 'facility': 'Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}