Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT00417651
Status:
COMPLETED
Last Update Posted:
2011-12-14
First Post:
2007-01-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testing for Bacterial Contamination During Gastric Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-13', 'studyFirstSubmitDate': '2007-01-02', 'studyFirstSubmitQcDate': '2007-01-02', 'lastUpdatePostDateStruct': {'date': '2011-12-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantitative and qualitative measure of the bacterial load and bacterial contamination of the abdomen during laparoscopic roux-en-y gastric bypass surgery while the gastrotomy is open to the abdominal cavity.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Bacterial', 'contamination', 'gastrotomy', 'Complications'], 'conditions': ['Gastric Surgery']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate whether creating a gastrotomy (hole in the stomach) during gastric surgery increases a patient's risk of intra-abdominal infection.\n\nWe hypothesize that a gastrotomy does not contaminate the abdomen with clinically significant bacterial pathogens.", 'detailedDescription': 'We propose to investigate the bacterial load and contamination patients experience during laparoscopic roux-en-y gastric bypass while having their gastrotomy for gastrojejunostomy. In all patients who undergo laparoscopic roux-en-y gastric bypass, the stomach must be opened to the peritoneal cavity while placing an anvil for gastrojejunostomy.\n\nSamples of gastric fluid will be collected and sent for analysis in all patients. Samples of peritoneal fluid will be collected prior to and after the creation of the gastrotomy, using intraperitoneal irrigation with approximately 500 cc of normal saline. Bacterial counts and identification will be recorded for each sample.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'observational studies patients morbidly obese.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any patient undergoing roux-en-y gastric bypass\n\nExclusion Criteria:\n\n* lack of consent'}, 'identificationModule': {'nctId': 'NCT00417651', 'briefTitle': 'Testing for Bacterial Contamination During Gastric Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Transgastric Bacterial Contamination of the Abdomen', 'orgStudyIdInfo': {'id': '2006H0078'}}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Center for Minimally Invasive Surgery', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Jeffrey W Hazey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSU'}, {'name': 'William S Melvin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OSU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jeffrey Hazey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Jeffrey Hazey', 'investigatorAffiliation': 'Ohio State University'}}}}