Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:26 PM
Study NCT ID:
NCT04340856
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2020-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008531', 'term': 'Megacolon'}], 'ancestors': [{'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003082', 'term': 'Colectomy'}, {'id': 'D054368', 'term': 'Laxatives'}, {'id': 'C000595212', 'term': 'polyethylene glycol 3350'}, {'id': 'D001726', 'term': 'Bisacodyl'}], 'ancestors': [{'id': 'D000099090', 'term': 'Surgical Procedures, Colorectal'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D005765', 'term': 'Gastrointestinal Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003408', 'term': 'Cresols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 67}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-25', 'studyFirstSubmitDate': '2020-04-07', 'studyFirstSubmitQcDate': '2020-04-07', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Constipation', 'timeFrame': 'One year after inpatient treatment (conservative/surgery)', 'description': 'Number of constipation crises leading to further hospital admissions: n'}], 'secondaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': 'Three months after inpatient treatment (conservative/surgery)', 'description': 'Hospital stay after inpatient treatment (conservative/surgery): days'}, {'measure': 'Adverse events', 'timeFrame': '30 days after inpatient treatment (conservative/surgery)', 'description': 'Any adverse event after inpatient treatment (conservative/surgery): n'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Megacolon'], 'conditions': ['Megacolon']}, 'referencesModule': {'references': [{'pmid': '17547862', 'type': 'BACKGROUND', 'citation': 'Hanauer SB, Wald A. Acute and chronic megacolon. Curr Treat Options Gastroenterol. 2007 Jun;10(3):237-47. doi: 10.1007/s11938-007-0017-z.'}, {'pmid': '25868630', 'type': 'BACKGROUND', 'citation': "O'Dwyer RH, Acosta A, Camilleri M, Burton D, Busciglio I, Bharucha AE. Clinical Features and Colonic Motor Disturbances in Chronic Megacolon in Adults. Dig Dis Sci. 2015 Aug;60(8):2398-407. doi: 10.1007/s10620-015-3645-5. Epub 2015 Apr 14."}, {'pmid': '30953226', 'type': 'BACKGROUND', 'citation': 'Wang XJ, Camilleri M. Chronic Megacolon Presenting in Adolescents or Adults: Clinical Manifestations, Diagnosis, and Genetic Associations. Dig Dis Sci. 2019 Oct;64(10):2750-2756. doi: 10.1007/s10620-019-05605-7. Epub 2019 Apr 5.'}, {'pmid': '39260392', 'type': 'DERIVED', 'citation': 'Schmitz D, Meier E, Axt S, Arlt G, Kienle P, Johannink J, Konigsrainer A, Mohammad O, Jakobs R, Willis S, Demir IE, Friess H, Hetjens S, Ebert MP, Reissfelder C, Vassilev G. Conservative versus surgical therapy for idiopathic and secondary megacolon or megarectum in adults - a retrospective multicentre controlled study. Z Gastroenterol. 2024 Nov;62(11):1913-1923. doi: 10.1055/a-2360-5008. Epub 2024 Sep 11.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.', 'detailedDescription': 'Megacolon may be defined as dilatation of the abdominal colon with a minimum of 9 cm in diameter and the absence of mechanical obstruction. Chronic megacolon in adults is an acquired uncommon condition that generally is associated with constipation. It has to be distinguished from other forms of megacolon such as acute toxic megacolon, acute non-toxic megacolon (Ogilvie´s-syndrome) and congenital megacolon (Hirschsprung disease). Regardless of concomitant diseases and causes, most patients with chronic megacolon were treated by laxative measures. Less is known about the optimal conservative therapy . If conservative measures fail, there are several surgical options, depending upon anorectal function. However, less in known about the optimal surgical therapy of patients with chronic megacolon. The aim of this retrospective cohort study is to analyze all available data of patients with chronic megacolon in three clinical centers with respect of conservative and surgical therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The databases of three clinical centers were systematically screened for patients with chronic megacolon (exclusion/inclusion criteria) in the time frame from 1.5.2005 to 1.5.2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic megacolon (colon diameter \\> 90 mm)\n\nExclusion Criteria:\n\n* Toxic megacolon\n* Ogilvie-syndrome\n* Hirschsprung disease\n* Mechanical colorectal obstruction'}, 'identificationModule': {'nctId': 'NCT04340856', 'acronym': 'CoMeC', 'briefTitle': 'Retrospective, Uncontrolled Cohort Study on the Therapy of Chronic Megalon', 'organization': {'class': 'OTHER', 'fullName': 'Theresienkrankenhaus und St. Hedwig-Klinik GmbH'}, 'officialTitle': 'Retrospective, Uncontrolled Multcentric Cohort Study on the Therapy of Chronic Megalon (CoMeC)', 'orgStudyIdInfo': {'id': 'Chronic Megacolon 001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'colon surgery', 'type': 'PROCEDURE', 'otherNames': ['Subtotal colectomy with ileorectal anastomosis', 'Diverting loop ileostomy', 'Colectomy with ileoanal anastomosis', 'Decompressive cecostomy with periodic antegrade enemas', 'Segmental colon resection'], 'description': 'There are no guidelines to direct surgical therapy in patients with chronic megacolon. Historically, it is the surgeons individual choice to use one of the above mentioned surgical treatments. Therefore, the aim of this study is to analyze the success and downsides of the different surgical approaches.'}, {'name': 'Laxatives', 'type': 'DRUG', 'otherNames': ['High-colonic water enema', 'Water-soluble contrast enema', 'PEG electrolyte solution', 'Colon decompression probe', 'Prucaloprid', 'Bisacodyl'], 'description': 'There are no guidelines to direct laxative measures in patients with chronic megacolon. Historically, it is the gastroenterologists individual choice to use one of the above mentioned laxative measures. Therefore, the aim of this study is to analyze the success and downsides of the different Laxative measures.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '68165', 'city': 'Mannheim', 'country': 'Germany', 'facility': 'Theresienkrankenhaus und St. Hedwigkliniken GmbH', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}], 'overallOfficials': [{'name': 'Daniel Schmitz, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Theresienkrankenhaus und St.Hedwigkliniken Mannheim,University of Heidelberg'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Theresienkrankenhaus und St. Hedwig-Klinik GmbH', 'class': 'OTHER'}, 'collaborators': [{'name': 'Technical University of Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}