Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2025-12-26 @ 4:15 AM
Study NCT ID:
NCT01413659
Status:
UNKNOWN
Last Update Posted:
2011-08-25
First Post:
2011-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013530', 'term': 'Surgical Wound Infection'}], 'ancestors': [{'id': 'D014946', 'term': 'Wound Infection'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2013-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-08-24', 'studyFirstSubmitDate': '2011-08-08', 'studyFirstSubmitQcDate': '2011-08-09', 'lastUpdatePostDateStruct': {'date': '2011-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of post-operative infection after elective colorectal surgery among patients with and without pre-operative symbiotic conditioning.', 'timeFrame': '15 months'}], 'secondaryOutcomes': [{'measure': 'The incidence of postoperative infection including surgical site infections (SSIs) and distant-site infections after elective colorectal surgery in patients whether or not receiving pre-operative symbiotic conditioning.', 'timeFrame': '15 months'}]}, 'conditionsModule': {'keywords': ['Colorectal surgery', 'Surgical site infection', 'Symbiotic'], 'conditions': ['Postoperative Wound Infection']}, 'descriptionModule': {'briefSummary': 'The objective of the study is to investigate whether peri-operative symbiotic treatment could reduce the risk of postoperative infections in patients undergoing elective colorectal surgery. This study was also designed to assess the risk-adjusted incidence and predictors of surgical site infections.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Both genders\n2. More than 14 years old\n3. Candidate for elective colorectal surgery\n\nExclusion Criteria:\n\n1. Denied written informed consent,\n2. Severe neutropenia, and\n3. Critically ill condition\n4. Not meeting inclusion criteria'}, 'identificationModule': {'nctId': 'NCT01413659', 'briefTitle': 'Evaluation of the Effect of Preoperative Symbiotic Bowel Conditioning on Surgical Site Infection After Elective Colorectal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'orgStudyIdInfo': {'id': 'MUMS-89619'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Symbiotic', 'description': 'Symbiotic is a combination of prebiotics and probiotics that is designed to have synergistic or additive effects benefiting the host', 'interventionNames': ['Biological: Symbiotic']}], 'interventions': [{'name': 'Symbiotic', 'type': 'BIOLOGICAL', 'description': 'Oral symbiotic every 8 h since 2 days before operation; Symbiotic resumes postoperatively on day +2 until day +4 for a total of 4 d of treatment (12 doses).', 'armGroupLabels': ['Symbiotic']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'HamidReza Naderi', 'oldOrganization': 'Imam Reza General Hospital - Surgical Oncology Research Center (SORC)'}}}}