Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-29 @ 1:10 AM
Study NCT ID:
NCT00922103
Status:
COMPLETED
Last Update Posted:
2010-09-13
First Post:
2009-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016737', 'term': 'Proctocolectomy, Restorative'}], 'ancestors': [{'id': 'D003082', 'term': 'Colectomy'}, {'id': 'D000099090', 'term': 'Surgical Procedures, Colorectal'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D000078542', 'term': 'Proctectomy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-10', 'studyFirstSubmitDate': '2009-06-12', 'studyFirstSubmitQcDate': '2009-06-15', 'lastUpdatePostDateStruct': {'date': '2010-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional outcome', 'timeFrame': 'after surgery: 3 months, 6 months, 12 months and yearly afterwards'}, {'measure': 'Quality of life and Health Status', 'timeFrame': 'after surgery: 3 months, 6 months, 12 months and yearly afterwards'}], 'secondaryOutcomes': [{'measure': 'histo-pathologic results', 'timeFrame': 'after surgery: 3 months, 6 months, 12 months and yearly afterwards'}, {'measure': 'endoscopic results', 'timeFrame': 'after surgery: 3 months, 6 months, 12 months and yearly afterwards'}, {'measure': 'morbidity and mortality', 'timeFrame': 'after surgery: 3 months, 6 months, 12 months and yearly afterwards'}, {'measure': 'ano-rectal physiology', 'timeFrame': 'after surgery: 3 months, 6 months, 12 months and yearly afterwards'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Colitis, Ulcerative', 'Ileo Neo Rectal Anastomosis', 'Ileal Pouch Anal Anastomosis', 'Quality of Life', 'functional results', 'reconstructive surgery', 'surgery'], 'conditions': ['Colitis, Ulcerative', 'Surgery']}, 'descriptionModule': {'briefSummary': 'For patients with ulcerative colitis, eligible for surgical treatment, which restorative surgical procedure: the standard ileo pouch anal anastomosis or the alternative ileo neo rectal anastomosis is the best in terms of complications, functional outcome and health status and quality of life.', 'detailedDescription': 'This research is designed to answer questions from the medical profession and patients´ community (Crohn en Colitis Ulcerosa Society, the Netherlands) whether the new INRA technique needs further development on a broader scale or not.\n\nThe research project will be conducted in the two institutes where INRA procedures have been carried out and in the UMCN to recruit matched control IPAA patients. There is a large experience with the IPAA procedure in this latter institute. The University of Tilburg will participate to work on health status and quality of life aspects. They have a large experience with quality of life research in general and have participated in QOL research in this topic before.\n\nThe aim of this historical cohort study is to establish the value of INRA, compared to IPAA, for patients with ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* UC patients with INRA procedure\n* Age, sex and disease specific matched group of UC-IPAA patients with temporary diverting ileostomy from the same period\n* Written informed consent\n\nExclusion criteria\n\n* Pregnancy\n* Malignancy (apart from basalioma or carcinoma-in-situ of cervix)\n* Psychiatric disease or inability to assess follow up'}, 'identificationModule': {'nctId': 'NCT00922103', 'briefTitle': 'A Study to Investigate the Ileo Neo Rectal Anastomosis Compared to the Ileo Pouch Anal Anastomosis for Patients With Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Elisabeth-TweeSteden Ziekenhuis'}, 'officialTitle': 'A Historical Cohort Study, to Investigate Morbidity, Functional and Physiological Outcome, as Well as Endoscopic and Histological Aspects and the Quality of Life, of the Ileo Neo Rectal Anastomosis (INRA) Compared to the Ileo Pouch Anal Anastomosis (IPAA), for Patients With Ulcerative Colitis (UC)', 'orgStudyIdInfo': {'id': '0426'}, 'secondaryIdInfos': [{'id': 'AMO nr. 04/074'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'INRA', 'description': 'Patients treated for medical refractory Ulcerative Colitis', 'interventionNames': ['Procedure: Ileal Neo Rectal Anastomosis']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'IPAA', 'description': 'Patients treated for medical refractory Ulcerative Colitis', 'interventionNames': ['Procedure: Ileal Pouch Anal Anastomosis']}], 'interventions': [{'name': 'Ileal Neo Rectal Anastomosis', 'type': 'PROCEDURE', 'description': 'Comparison of the Ileal Neo Rectal Anastomosis to the Ileal Pouch Anal Anastomosis in patients treated for medical refractory Ulcerative Colitis', 'armGroupLabels': ['INRA']}, {'name': 'Ileal Pouch Anal Anastomosis', 'type': 'PROCEDURE', 'description': 'Comparison of the Ileal Pouch Anal Anastomosis to the Ileal Neo Rectal Anastomosis in patients treated for medical refractory Ulcerative Colitis', 'armGroupLabels': ['IPAA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6500 HB', 'city': 'Nijmegen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'University Medical Centre St Radboud', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '5022 GC', 'city': 'Tilburg', 'state': 'North Brabant', 'country': 'Netherlands', 'facility': 'St Elisabeth Hospital', 'geoPoint': {'lat': 51.55551, 'lon': 5.0913}}], 'overallOfficials': [{'name': 'JT Heikens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St Elisabeth Hospital, Tilburg, The Netherlands'}, {'name': 'D de Jong, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Centre St Radboud, Nijmegen, The Netherlands'}, {'name': 'JLJM Teepen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'St Elisabeth Hospital, Tilburg, The Netherlands'}, {'name': 'JHJM van Krieken, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Centre St Radboud, The Netherlands'}, {'name': 'HG Gooszen, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Centre St Radboud, Nijmegen, The Netherlands'}, {'name': 'J de Vries, Md, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'St Elisabeth Hospital, Tilburg, The Netherlands'}, {'name': 'CJHM van Laarhoven, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Medical Centre St Radboud, The Netherlands'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Elisabeth-TweeSteden Ziekenhuis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radboud University Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'JT Heikens, MD', 'oldOrganization': 'St Elisabeth Hospital, Tilburg, The Netherlands'}}}}