Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-05 @ 8:05 PM
Study NCT ID:
NCT02997267
Status:
COMPLETED
Last Update Posted:
2018-04-03
First Post:
2016-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Closure of Protective Ileostomy in Rectal Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-31', 'studyFirstSubmitDate': '2016-12-05', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2018-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of postoperative fistulas', 'timeFrame': '3 months after surgery', 'description': 'number of patients with the fistula of the anastomosis'}], 'secondaryOutcomes': [{'measure': 'Timing of anticancer therapy', 'timeFrame': '3 months after surgery', 'description': 'Time to the beginning of adiuvant chemotherapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Ileostomy - Stoma']}, 'descriptionModule': {'briefSummary': 'The aim of the study was to compare the restoration of the GI tract by the closure of protective ileostomy after low anterior resection for rectal cancer after 14 days and more than 3 months.', 'detailedDescription': 'The closure of the protective ileostomy created during the low anterior resection for rectal cancer to protect the colo-rectal anastomosis is inevitable to restore the continuity of the gastrointestinal tract. It usually takes place several months after the primary surgery, because the patients starts chemotherapy and cannot undergo the procedure during the therapy. It results in the relative low quality of life of the patient, as well as often leads to complications. Therefore, it seem reasonable to close the stoma as soon as possible to take the burden off patient.\n\nIt is well known that the healing process of the anastomosis runs in the three phases, but only two first are crucial for the clinical result. The second takes place between 5th and 14th postoperative day. Therefore it should be possible to perform successful restoration of the GI tract already after two weeks after operation, and not after many moths.\n\nThe aim of the study was to compare the restoration of the GI tract after 14 days and more than 3 months, so to compare the traditional and early strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* more than 18 year old\n* the presence of the protective ileostomy created during the low anterior resection to protect the colo-rectal anastomosis\n\nExclusion Criteria:\n\n* the presence of the protective ileostomy created during any other procedure than the low anterior resection to protect the colo-rectal anastomosis\n* age \\< 18 yo'}, 'identificationModule': {'nctId': 'NCT02997267', 'acronym': 'ECPIS', 'briefTitle': 'Early Closure of Protective Ileostomy in Rectal Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': "Stanley Dudrick's Memorial Hospital"}, 'officialTitle': 'The Early Closure of the Protective Ileostomy After Low Anterior Resection Enables Correct Start of Chemotherapy', 'orgStudyIdInfo': {'id': 'Zespolenia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early closure', 'description': 'Closure of the ileostomy 14 days after the primary operation, in which it was created.', 'interventionNames': ['Procedure: Closure of the ileostomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late closure', 'description': 'Closure of the ileostomy more than 90 days after the primary operation, in which it was created.', 'interventionNames': ['Procedure: Closure of the ileostomy']}], 'interventions': [{'name': 'Closure of the ileostomy', 'type': 'PROCEDURE', 'description': 'Surgical closure of the protective ileostomy (reconnection of intestinal loops)', 'armGroupLabels': ['Early closure', 'Late closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32-050', 'city': 'Skawina', 'country': 'Poland', 'facility': "Stanley Dudrick's Memorial Hospital", 'geoPoint': {'lat': 49.97524, 'lon': 19.82869}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is no plan to make individual participant data (IPD) available to other researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Stanley Dudrick's Memorial Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of the Department', 'investigatorFullName': 'Stanislaw Klek', 'investigatorAffiliation': "Stanley Dudrick's Memorial Hospital"}}}}