Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:38 PM
Study NCT ID:
NCT01378832
Status:
COMPLETED
Last Update Posted:
2011-06-22
First Post:
2011-06-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}, {'id': 'D018784', 'term': 'Abdominal Abscess'}, {'id': 'D014946', 'term': 'Wound Infection'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000038', 'term': 'Abscess'}, {'id': 'D013492', 'term': 'Suppuration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-21', 'studyFirstSubmitDate': '2011-06-20', 'studyFirstSubmitQcDate': '2011-06-21', 'lastUpdatePostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical site infection', 'timeFrame': '30 days', 'description': 'Intra-abdominal abscess and wound infection will be investigated during the first 30 days after colorectal surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intra-abdominal abscess', 'wound infection', 'colorectal surgery'], 'conditions': ['Surgical Site Infection']}, 'referencesModule': {'references': [{'pmid': '22265220', 'type': 'DERIVED', 'citation': 'Ruiz-Tovar J, Santos J, Arroyo A, Llavero C, Armananzas L, Lopez-Delgado A, Frangi A, Alcaide MJ, Candela F, Calpena R. Effect of peritoneal lavage with clindamycin-gentamicin solution on infections after elective colorectal cancer surgery. J Am Coll Surg. 2012 Feb;214(2):202-7. doi: 10.1016/j.jamcollsurg.2011.10.014.'}]}, 'descriptionModule': {'briefSummary': 'Intrabdominal antibiotic irrigation will reduce wound and intrabdominal infection.', 'detailedDescription': 'A prospective, randomized study was performed between January and December 2010. Patient inclusion criteria were a diagnosis of colorectal neoplasms and plans to undergo an elective curative surgery. Patients were divided into 2 groups: Group 1 (intra-abdominal irrigation with normal saline) and Group 2 (intraperitoneal irrigation with a solution of 240 mg gentamicin and 600 mg clindamycin). The occurrence of wound infections and intra-abdominal abscesses were investigated. Following the anastomosis, a microbiological sample of the peritoneal surface was obtained (sample 1). A second sample was collected following an irrigation with normal saline (sample 2). Finally, the peritoneal cavity was irrigated with a gentamicin-clindamycin solution and a third sample was obtained (sample 3).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of colorectal neoplasms and 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* an anastomotic leak in the postoperative course'}, 'identificationModule': {'nctId': 'NCT01378832', 'acronym': 'lavage', 'briefTitle': 'Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Colorectal Cancer Infection in Elective Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Universidad Miguel Hernandez de Elche'}, 'officialTitle': 'Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Infection in Elective Surgery', 'orgStudyIdInfo': {'id': 'jruiztovar'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Intra-peritoneal antibiotic lavage', 'type': 'PROCEDURE', 'description': 'The lavage was performed immediately prior to closure of the abdominal wall. Prior to the lavage, a microbiological sample from the peritoneal surface (parietal and visceral) was obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline, similar to the one performed in Group 1. After this lavage, a new microbiological sample was obtained from the peritoneal surface (sample 2), and a second lavage with an antibiotic solution, including gentamicin (240 mg) and clindamycin (600 mg) dissolved in 500 ml normal saline was performed. During this lavage, the solution was allowed to sit in the abdominal cavity for 3 minutes. After aspirating the lavage, a third microbiological sample was obtained in the same way as the two previous ones (sample 3).'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad Miguel Hernandez de Elche', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jaime Ruiz-Tovar', 'oldOrganization': 'Universidad Miguel Hernandez de Elche'}}}}