Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2025-12-26 @ 4:10 AM
Study NCT ID:
NCT00457327
Status:
TERMINATED
Last Update Posted:
2008-06-05
First Post:
2007-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}], 'ancestors': [{'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': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'whyStopped': 'RCT with same hypothesis ended and showed a superiority for protective ileostomy after lower anterior rectum resection.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-06-04', 'studyFirstSubmitDate': '2007-04-04', 'studyFirstSubmitQcDate': '2007-04-04', 'lastUpdatePostDateStruct': {'date': '2008-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-04-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morbidity and mortality until day 30 postoperative'}], 'secondaryOutcomes': [{'measure': 'Quality of life'}, {'measure': 'Ranking of factors influencing quality of life'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['protective ileostomy', 'rectal cancer', 'low anterior resection'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '19333040', 'type': 'DERIVED', 'citation': 'Ulrich AB, Seiler C, Rahbari N, Weitz J, Buchler MW. Diverting stoma after low anterior resection: more arguments in favor. Dis Colon Rectum. 2009 Mar;52(3):412-8. doi: 10.1007/DCR.0b013e318197e1b1.'}], 'seeAlsoLinks': [{'url': 'http://www.sdgc.de/', 'label': 'Study Center of the German Surgical Society'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer', 'detailedDescription': 'Since introduction of total mesorectal excision prognosis and quality of life of patients with rectal cancer of the middle or lower third of the rectum could be improved significantly. There is no valid data about the need of protective ileostomy in these patients. About 10% of the patients develop insufficiency of the anastomosis and might benefit from ileostomy whereas about 90% would not have required protective ileostomy retrospectively. Aim of the study is to show that protective ileostomy is not required if several criteria are fulfilled and early measures in case of clinical impairment are defined. Therefore eligibility criteria include safely performed stapler anastomosis with complete rings and control of impermeability by air insufflation. In the event of clinical impairment in the postoperative course CT scan with KM filling of the rectum to exclude insufficiency of the anastomosis will be performed. In case of insufficiency protective ileostomy will be created. 40 patients will be included.\n\nComparison: Patients with resectable rectal cancer of the middle or lower third will be intraoperatively randomized to either protective ileostomy or no ileostomy at all.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* radical resectable rectal cancer\n* low sphincter-preserving resection of carcinomas of the lower and middle third\n* preoperative normal continence\n* preoperative normal sphincter function\n* complete rings after stapler anastomosis\n* impermeability of anastomosis for air\n* written informed consent\n\nExclusion Criteria:\n\n* reduced cooperation or drug abuse\n* pregnancy\n* psychosis\n* age under 18 years'}, 'identificationModule': {'nctId': 'NCT00457327', 'briefTitle': 'Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Pilot Study for Evaluation of the Need for Protective Ileostomy After Low Anterior Resection Due to Rectal Cancer', 'orgStudyIdInfo': {'id': '433/2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'protective ileostomy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '69120', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Clinical Study Center Surgery, Department of Surgery, University of Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'overallOfficials': [{'name': 'Markus W Buchler, Chairman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Surgery, University of Heidelberg, Medical School'}, {'name': 'Peter Kienle, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery, University of Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'University of Heidelberg', 'oldOrganization': 'Department of General, Visceral and Transplantation Surgery'}}}}