Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-04-14 @ 10:12 PM
Study NCT ID:
NCT02399059
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2015-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-25', 'studyFirstSubmitDate': '2015-03-23', 'studyFirstSubmitQcDate': '2015-03-25', 'lastUpdatePostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global survival', 'timeFrame': '36 months after intervention'}], 'secondaryOutcomes': [{'measure': 'Disease free survival', 'timeFrame': '36 months after intervention'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['recurrence'], 'conditions': ['Colorectal Tumors']}, 'descriptionModule': {'briefSummary': 'Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome.', 'detailedDescription': 'Antibiotics combined with lavage have demonstrated a reduction in the bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, as immunologic defense is focused on controlling the septic focus, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome. The aim of this study is to evaluate prospectively the effect of peritoneal lavage with clindamycin and gentamicin on the oncologic outcome of colorectal tumours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of colon neoplasms\n* plans to undergo an elective surgery with curative aims\n\nExclusion Criteria:\n\n* preoperative diagnosis of chronic renal failure (because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption)\n* allergy to gentamicin or clindamycin.'}, 'identificationModule': {'nctId': 'NCT02399059', 'briefTitle': 'Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome', 'organization': {'class': 'OTHER', 'fullName': 'Hospital General Universitario Elche'}, 'officialTitle': 'Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution During Elective Colorectal Cancer Surgery on the Oncologic Outcome', 'orgStudyIdInfo': {'id': 'HURJ2015-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Antibiotic lavage', 'description': 'Peritoneal irrigation with Gentamycin - clndamycin solution', 'interventionNames': ['Procedure: Antibiotic lavage']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Normal saline lavage', 'description': 'Peritoneal irrigation with normal saline', 'interventionNames': ['Procedure: Normal saline lavage']}], 'interventions': [{'name': 'Antibiotic lavage', 'type': 'PROCEDURE', 'description': 'Peritoneal irrigation with gentamycin-clindamycin solution', 'armGroupLabels': ['Antibiotic lavage']}, {'name': 'Normal saline lavage', 'type': 'PROCEDURE', 'description': 'Peritoneal irrigation with normal saline', 'armGroupLabels': ['Normal saline lavage']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jaime Ruiz-Tovar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Rey Juan Carlos'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital General Universitario Elche', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jaime Ruiz-Tovar, MD, PhD', 'investigatorAffiliation': 'Hospital General Universitario Elche'}}}}