Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-31 @ 4:38 PM
Study NCT ID:
NCT02609451
Status:
TERMINATED
Last Update Posted:
2017-08-31
First Post:
2015-09-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Closure of Protective Ileostomy 2 vs. 12 Weeks After TME
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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 71}}, 'statusModule': {'whyStopped': 'Evidence of bad outcome after interims analysis', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-29', 'studyFirstSubmitDate': '2015-09-24', 'studyFirstSubmitQcDate': '2015-11-18', 'lastUpdatePostDateStruct': {'date': '2017-08-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality Of Life (GQLI - Questionnaire)', 'timeFrame': '6 weeks', 'description': 'Quality Of Life Survey using the GQLI - Questionnaire'}], 'secondaryOutcomes': [{'measure': 'Feasibility (via Visual Analogue Scale)', 'timeFrame': 'intraoperatively', 'description': 'Surgical Feasibility including blood loss, blood oozing, epifascial and intrabdominal adhesions, operating time and difference in bowel diameter'}, {'measure': 'Safety as assessed by Morbidity, Mortality', 'timeFrame': '6 weeks, 16 weeks', 'description': 'Morbidity, Mortality'}, {'measure': 'Quality Of Life (EORTC - Questionnaire)', 'timeFrame': 'preoperative (preOP), 6 weeks, 16 weeks', 'description': 'Quality Of Life Survey using the EORTC - QLQ C30 - Questionnaire'}, {'measure': 'Quality Of Life (GQLI - Questionnaire)', 'timeFrame': 'preOP, 16 weeks', 'description': 'Quality Of Life Survey using the GQLI - Questionnaire'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['quality of life', 'feasibility', 'safety', 'protective ileostomy closure'], 'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '16598401', 'type': 'BACKGROUND', 'citation': 'Thalheimer A, Bueter M, Kortuem M, Thiede A, Meyer D. Morbidity of temporary loop ileostomy in patients with colorectal cancer. Dis Colon Rectum. 2006 Jul;49(7):1011-7. doi: 10.1007/s10350-006-0541-2.'}, {'pmid': '11531870', 'type': 'BACKGROUND', 'citation': "O'Leary DP, Fide CJ, Foy C, Lucarotti ME. Quality of life after low anterior resection with total mesorectal excision and temporary loop ileostomy for rectal carcinoma. Br J Surg. 2001 Sep;88(9):1216-20. doi: 10.1046/j.0007-1323.2001.01862.x."}, {'pmid': '12780582', 'type': 'BACKGROUND', 'citation': 'Hallbook O, Matthiessen P, Leinskold T, Nystrom PO, Sjodahl R. Safety of the temporary loop ileostomy. Colorectal Dis. 2002 Sep;4(5):361-364. doi: 10.1046/j.1463-1318.2002.00398.x.'}, {'pmid': '34343161', 'type': 'DERIVED', 'citation': 'Elsner AT, Brosi P, Walensi M, Uhlmann M, Egger B, Glaser C, Maurer CA. Closure of Temporary Ileostomy 2 Versus 12 Weeks After Rectal Resection for Cancer: A Word of Caution From a Prospective, Randomized Controlled Multicenter Trial. Dis Colon Rectum. 2021 Nov 1;64(11):1398-1406. doi: 10.1097/DCR.0000000000002182.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the feasibility, safety, and quality of life (QOL) in patients (pts) undergoing protective ileostomy closure after 2 weeks with a closure after 12 weeks.', 'detailedDescription': 'In three surgical departments between 2007 and 2013, 72 pts with total mesorectal excision and coloanal or low colorectal anastomosis for rectal cancer were randomly assigned to closure of their protective ileostomy after 2 weeks (group A, 37 pts) or 12 weeks (group B, 35 pts). One day before planned stoma closure, the coloanal/colorectal anastomosis was checked by palpation, contrast enema via ileostomy and, in case of hazards, by proctoscopy. Perioperative data was assessed prospectively using numeric values, visual analogue scales (VAS, 0 = lowest value, 100 = highest value) and QOL-index (GQLI, max. 144 points). Complications were recorded prospectively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* anastomosis ≤ 5cm from anal verge\n* age \\>18 years\n* informed consent\n* uneventful course after first operation\n\nExclusion Criteria:\n\n* pregnancy\n* allergy to contrast agent\n* severe non-surgical complications\n* evident abdominal - pelvic complications'}, 'identificationModule': {'nctId': 'NCT02609451', 'acronym': 'Closure2vs12', 'briefTitle': 'Closure of Protective Ileostomy 2 vs. 12 Weeks After TME', 'organization': {'class': 'OTHER', 'fullName': 'Kantonsspital Liestal'}, 'officialTitle': 'Closure of Protective Ileostomy 2 vs. 12 Weeks Following Total Mesorectal Excision (TME) for Rectal Surgery: Interim Analysis of a Multicentre, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'EKBB-REF-NR-266/07_Ileostomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2 weeks', 'description': 'Ileostomy closure after 2 weeks', 'interventionNames': ['Procedure: Ileostomy closure']}, {'type': 'EXPERIMENTAL', 'label': '12 weeks', 'description': 'Ileostomy closure after 12 weeks', 'interventionNames': ['Procedure: Ileostomy closure']}], 'interventions': [{'name': 'Ileostomy closure', 'type': 'PROCEDURE', 'description': 'Ileostomy closure at a different time point', 'armGroupLabels': ['12 weeks', '2 weeks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4410', 'city': 'Liestal', 'state': 'Basel-Landschaft', 'country': 'Switzerland', 'facility': 'Kantonspital Baselland Liestal', 'geoPoint': {'lat': 47.48455, 'lon': 7.73446}}], 'overallOfficials': [{'name': 'Christoph A. Maurer, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cantonal Hosptal, Baselland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kantonsspital Liestal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}