Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-26 @ 7:37 AM
Study NCT ID:
NCT00782457
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2008-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With 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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-10', 'completionDateStruct': {'date': '2010-12'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2008-10-29', 'studyFirstSubmitQcDate': '2008-10-29', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lymph nodes isolated, circumferential margin involved, rate of complications and length of stay', 'timeFrame': '1 month'}]}, 'conditionsModule': {'conditions': ['RECTAL CANCER']}, 'referencesModule': {'references': [{'pmid': '19644973', 'type': 'DERIVED', 'citation': 'Lujan J, Valero G, Hernandez Q, Sanchez A, Frutos MD, Parrilla P. Randomized clinical trial comparing laparoscopic and open surgery in patients with rectal cancer. Br J Surg. 2009 Sep;96(9):982-9. doi: 10.1002/bjs.6662.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare laparoscopic versus open approach on the surgical treatment of mid and low-lying rectal cancer, both performed by the same surgical team with experience in open colorectal surgery and advanced laparoscopic surgery, assessing preoperative and anatomopathological results and long-term outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mid- and low-lying rectal cancer (between 0 and 11 cm from the anal margin)\n* Histology of adenocarcinoma\n\nExclusion Criteria:\n\n* Locally advanced disease (T4)\n* Emergency surgery\n* Rectal cancer over familial colic polyposis'}, 'identificationModule': {'nctId': 'NCT00782457', 'briefTitle': 'Prospective Randomised Study Comparing Laparoscopic Versus Open Surgery in Patients With Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Virgen de la Arrixaca'}, 'orgStudyIdInfo': {'id': 'D-08-00770'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'OPEN SURGERY', 'interventionNames': ['Procedure: RECTAL CANCER RESECTION']}, {'type': 'EXPERIMENTAL', 'label': 'LAPAROSCOPIC SURGERY', 'interventionNames': ['Procedure: RECTAL CANCER RESECTION']}], 'interventions': [{'name': 'RECTAL CANCER RESECTION', 'type': 'PROCEDURE', 'armGroupLabels': ['LAPAROSCOPIC SURGERY', 'OPEN SURGERY']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Virgen de la Arrixaca', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Juan Lujan', 'oldOrganization': 'HUV Arrixaca'}}}}