Ignite Creation Date:
2025-12-24 @ 5:10 PM
Ignite Modification Date:
2025-12-28 @ 5:10 AM
Study NCT ID:
NCT01173250
Status:
COMPLETED
Last Update Posted:
2010-08-16
First Post:
2010-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D011125', 'term': 'Adenomatous Polyposis Coli'}], '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'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL'}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'lastUpdateSubmitDate': '2010-08-13', 'studyFirstSubmitDate': '2010-07-30', 'studyFirstSubmitQcDate': '2010-07-30', 'lastUpdatePostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-02', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['total proctocolectomy with ileal pouch anal anastomosis with and without ileostomy'], 'conditions': ['Ulcerative Colitis', 'Familial Adenomatous Polyposis']}, 'descriptionModule': {'briefSummary': 'Total proctocolectomy with ileal pouch anal anastomosis is the first choice surgical operation for management of ulcerative colitis and familial adenomatous polyposis. The addition of diverting ileostomy may reduce septic complications. In this randomized study the investigators compare two groups of patients with stapled ileoanal pouch one of them had diverting ileostomy and in the other this step is omitted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients having total proctocolectomy with ileal pouch anal anastomosis.\n\nExclusion Criteria:\n\n* hypoalbuminemia\n* prolonged steroid use\n* anemia\n* anastomosis under tension\n* leak with air test\n* bleeding\n* poor vascular supply of anastomosis'}, 'identificationModule': {'nctId': 'NCT01173250', 'briefTitle': 'Is Diverting Ileostomy Necessary in Stapled Ileoanal Pouch?', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'orgStudyIdInfo': {'id': '251068'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'stapled ileoanal pouch without diverting ileostomy', 'interventionNames': ['Procedure: omitting diverting ileostomy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'stapled ileoanal pouch with diverting ileostomy', 'interventionNames': ['Procedure: adding diverting ileostomy']}], 'interventions': [{'name': 'adding diverting ileostomy', 'type': 'PROCEDURE', 'armGroupLabels': ['stapled ileoanal pouch with diverting ileostomy']}, {'name': 'omitting diverting ileostomy', 'type': 'PROCEDURE', 'armGroupLabels': ['stapled ileoanal pouch without diverting ileostomy']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}}}}