Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-31 @ 6:43 PM
Study NCT ID:
NCT05210556
Status:
COMPLETED
Last Update Posted:
2025-03-28
First Post:
2022-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Antibiotic Bowel Preparation in Gynecologic Oncology 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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 778}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-01-13', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical Site Infection Rates Associated with Antibiotic Bowel Prep', 'timeFrame': '2019-2021', 'description': 'Rate of surgical site infection rate as associated with or without use of antibiotic bowel preparation'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['surgical site infection', 'gynecologic cancer'], 'conditions': ['Surgical Site Infection', 'Surgical Complication', 'Gynecologic Cancer']}, 'referencesModule': {'references': [{'pmid': '19160191', 'type': 'BACKGROUND', 'citation': 'Nelson RL, Glenny AM, Song F. Antimicrobial prophylaxis for colorectal surgery. Cochrane Database Syst Rev. 2009 Jan 21;(1):CD001181. doi: 10.1002/14651858.CD001181.pub3.'}, {'pmid': '25607761', 'type': 'BACKGROUND', 'citation': 'Morris MS, Graham LA, Chu DI, Cannon JA, Hawn MT. Oral Antibiotic Bowel Preparation Significantly Reduces Surgical Site Infection Rates and Readmission Rates in Elective Colorectal Surgery. Ann Surg. 2015 Jun;261(6):1034-40. doi: 10.1097/SLA.0000000000001125.'}, {'pmid': '32112733', 'type': 'BACKGROUND', 'citation': 'Kalogera E, Van Houten HK, Sangaralingham LR, Borah BJ, Dowdy SC. Use of bowel preparation does not reduce postoperative infectious morbidity following minimally invasive or open hysterectomies. Am J Obstet Gynecol. 2020 Aug;223(2):231.e1-231.e12. doi: 10.1016/j.ajog.2020.02.035. Epub 2020 Feb 26.'}, {'pmid': '4743867', 'type': 'BACKGROUND', 'citation': 'Nichols RL, Broido P, Condon RE, Gorbach SL, Nyhus LM. Effect of preoperative neomycin-erythromycin intestinal preparation on the incidence of infectious complications following colon surgery. Ann Surg. 1973 Oct;178(4):453-62. doi: 10.1097/00000658-197310000-00008. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery.', 'detailedDescription': 'This is a retrospective chart review study. Patients who underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist will be identified and their chart reviewed for demographic data of age, race, BMI, comorbidities, and type of surgery. Those patients who had a deep organ/space surgical site infection within 30 days postoperatively will be identified. The numbers of these infections before and after August 2020, at which time all patients moving forwards were prescribed antibiotic bowel preparation, will then be statistically analyzed and compared to see if the institution of the antibiotic bowel preparation was associated with a reduction in surgical site infection.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who had intra-abdominal surgery by a WellSpan gynecologic oncologist from 2019-2021 as identified by review of the surgical schedule.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Underwent scheduled intra-abdominal surgery with a WellSpan gynecologic oncologist\n\nExclusion Criteria:\n\n* Unscheduled surgery\n* Intraoperative consult by a WellSpan gynecologic oncologist'}, 'identificationModule': {'nctId': 'NCT05210556', 'briefTitle': 'Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery', 'organization': {'class': 'OTHER', 'fullName': 'WellSpan Health'}, 'officialTitle': 'Oral Antibiotic Bowel Preparation in Gynecologic Oncology Surgery', 'orgStudyIdInfo': {'id': '1847220-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'No Antibiotic Bowel Prep', 'description': 'Patients who did not receive a preoperative antibiotic bowel preparation', 'interventionNames': ['Other: Diagnosed with Surgical Site Infection']}, {'label': 'Antibiotic Bowel Prep', 'description': 'Patients who did receive a preoperative antibiotic bowel preparation'}], 'interventions': [{'name': 'Diagnosed with Surgical Site Infection', 'type': 'OTHER', 'description': 'As an observational study, this notates patients who were diagnosed with a deep organ/space surgical site infection within 30 days of surgery', 'armGroupLabels': ['No Antibiotic Bowel Prep']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17403', 'city': 'York', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'WellSpan', 'geoPoint': {'lat': 39.9626, 'lon': -76.72774}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'WellSpan Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eav Lim', 'investigatorAffiliation': 'WellSpan Health'}}}}