Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-31 @ 7:54 PM
Study NCT ID:
NCT05565508
Status:
COMPLETED
Last Update Posted:
2022-10-04
First Post:
2022-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 172}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-01', 'studyFirstSubmitDate': '2022-09-27', 'studyFirstSubmitQcDate': '2022-10-01', 'lastUpdatePostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time needed to access the peritoneal cavity', 'timeFrame': 'the first 15 minutes of operation', 'description': 'time needed to access the peritoneal cavity'}, {'measure': 'numbers of trials till the good peritoneal access achieved', 'timeFrame': 'the first 15 minutes of operation', 'description': 'numbers of trials till the good peritoneal access achieved'}], 'secondaryOutcomes': [{'measure': 'rate of complications', 'timeFrame': 'the first 15 minutes of operation', 'description': 'rate of complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery', 'detailedDescription': "the study discussed the safety of new technique for primary port insertion in cases of previous abdominal and pelvic surgery and comparing the new technique group (A) patients to already known technique called (Hasson's technique) group (B) patients"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients more than 18 year-old with history of previous abdominal and/or pelvic surgery.\n* underwent laparoscopic surgery in general surgery departments in both centers from March, 2020 to july, 2022.\n\nExclusion Criteria:\n\n* Patients with distended abdomen due to bowel obstruction.\n* Patients with uncorrected coagulopathy.'}, 'identificationModule': {'nctId': 'NCT05565508', 'briefTitle': 'Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'a Prospective Randomized Controlled Trial Evaluating Safe Laparoscopic Access in Patients With Previous Abdominal and Pelvic Surgery', 'orgStudyIdInfo': {'id': 'zuh248'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'new laparoscopic access technique', 'description': 'in which we used our new laparoscopic access', 'interventionNames': ['Procedure: new laparoscopic access technique for group a']}, {'type': 'EXPERIMENTAL', 'label': "Hasson's technique", 'description': "in which we used the well-known Hasson's technique for primary laparoscopic access", 'interventionNames': ["Procedure: Hasson's technique for laparoscopic access in group b"]}], 'interventions': [{'name': 'new laparoscopic access technique for group a', 'type': 'PROCEDURE', 'otherNames': ['new laparoscopic access technique'], 'description': 'new laparoscopic access technique through the epigastric region', 'armGroupLabels': ['new laparoscopic access technique']}, {'name': "Hasson's technique for laparoscopic access in group b", 'type': 'PROCEDURE', 'description': "Hasson's technique for laparoscopic access in group b", 'armGroupLabels': ["Hasson's technique"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Zagazig', 'country': 'Egypt', 'facility': 'Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'prof. Dr', 'investigatorFullName': 'Mohamed lotfy', 'investigatorAffiliation': 'Zagazig University'}}}}