Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2026-01-05 @ 6:32 PM
Study NCT ID:
NCT03009604
Status:
UNKNOWN
Last Update Posted:
2017-01-04
First Post:
2017-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Simethicone Improve Operative Field in Gynecological Operations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012841', 'term': 'Simethicone'}, {'id': 'D004733', 'term': 'Enema'}], 'ancestors': [{'id': 'D004129', 'term': 'Dimethylpolysiloxanes'}, {'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-02', 'studyFirstSubmitDate': '2017-01-02', 'studyFirstSubmitQcDate': '2017-01-02', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the degree of small & large bowel preparation', 'timeFrame': 'intraoperative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Benign Gynecologic Neoplasm']}, 'descriptionModule': {'briefSummary': 'Mechanical bowel preparation aims to decrease the volume fecal content in the colon, which thereby decreases the total colony count of bacteria, thus, decreasing peritoneal contamination in case of bowel injury, improving the access to the surgical field and facilitating intraoperative bowel manipulation'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nGynecological operations for benign conditions as hysterectomy, ovarian cystectomy and myomectomy.\n\nExclusion Criteria:\n\n1. History of allergic reaction to study drugs.\n2. More than one scar of previous operation.\n3. Suspicious of malignancy.\n4. Psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT03009604', 'briefTitle': 'Does Simethicone Improve Operative Field in Gynecological Operations', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'orgStudyIdInfo': {'id': 'SIM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simethicone', 'description': 'women take 6 tablets (2 tablets after each meal) and to fast overnight before the operation', 'interventionNames': ['Drug: Simethicone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enema', 'description': 'women take 3 rectal Enema (8:00 pm, 12:00 am \\& 8:00 am) and to fast over night before the operation.', 'interventionNames': ['Drug: Enema']}], 'interventions': [{'name': 'Simethicone', 'type': 'DRUG', 'description': 'Simethicone 40mg oral tablets', 'armGroupLabels': ['Simethicone']}, {'name': 'Enema', 'type': 'DRUG', 'description': 'sodium dihydrogen phosphate dihydrate 19.2 gram \\& disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water', 'armGroupLabels': ['Enema']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Altayeb Mostafa', 'role': 'CONTACT'}], 'facility': 'Assiut University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Altayeb Mostafa, MBBCh', 'role': 'CONTACT', 'phone': '00201003722811'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Altayeb Abd alal Mostafa Mohammad', 'investigatorAffiliation': 'Assiut University'}}}}