Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-20 @ 12:57 AM
Study NCT ID:
NCT01932957
Status:
COMPLETED
Last Update Posted:
2021-03-11
First Post:
2013-08-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2013-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-08', 'studyFirstSubmitDate': '2013-08-27', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2021-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hospital stay', 'timeFrame': '5 days', 'description': 'Hospital stay will be compared between the two groups'}], 'secondaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '24 hours', 'description': 'Pain scores b means of visual analog pain scale'}, {'measure': 'Theatre time', 'timeFrame': '1 day', 'description': 'Theatre times will be measured and compared for the two groups'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Ruptured ectopic pregnancy'], 'conditions': ['Ruptured Ectopic Pregnancy']}, 'descriptionModule': {'briefSummary': 'Standard management for patients with ruptured ectopic pregnancies at our institution is treatment by laparotomy. This trail will investigate the feasibility of treatment with laparoscopy and will look at outcomes such as hospital stay and pain experienced\n\nThe hypothesis is that laparoscopy is a feasible treatment option associated with shorter hospital stay and less pain', 'detailedDescription': 'Laparoscopic surgery for the surgical management of women diagnosed with ectopic pregnancies has become the standard of care in many institutions around the world. Laparotomy is still the standard of care at Kalafong Hospital. There is very little high quality evidence with regard to the optimal surgical management approach for women with ruptured ectopic pregnancies.\n\nThe study aims to compare laparotomy with laparoscopy in this group of women with regards to outcomes such as length of hospital stay, number of days off work and pain.\n\nThis randomised study will be conducted at Kalafong hospital, on 140 patients diagnosed with ruptured ectopic pregnancy who are haemodynamically stable and are able and willing to provide informed consent.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Able to give informed consent\n* must have two of the following three:\n* systolic blood pressure \\>90 mmHg\n* pulse rate \\<100 beats per minute\n* heamoglobin \\>8 g/dL\n\nExclusion Criteria:\n\n* \\<18 years\n* haemodynamically unstable\n* not able to give informed consent'}, 'identificationModule': {'nctId': 'NCT01932957', 'briefTitle': 'Laparascopy Versus Laparatomy in the Management of Ruptured Ectopic Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'University of Pretoria'}, 'officialTitle': 'A RANDOMISED TRIAL COMPARING LAPARASCOPY VERSUS LAPAROTOMY IN THE MANAGEMENT OF WOMEN DIAGNOSED WITH ECTOPIC PREGNANCY', 'orgStudyIdInfo': {'id': 'Ectopic Trial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Laparotomy arm', 'description': 'Standard treatment', 'interventionNames': ['Procedure: Laparotomy arm']}, {'type': 'EXPERIMENTAL', 'label': 'Laparoscopy arm', 'description': 'Treatment by laparoscopy', 'interventionNames': ['Procedure: Laparoscopy arm']}], 'interventions': [{'name': 'Laparotomy arm', 'type': 'PROCEDURE', 'description': 'Laparotomy as standard treatment for ruptured ectopic pregnancy', 'armGroupLabels': ['Laparotomy arm']}, {'name': 'Laparoscopy arm', 'type': 'PROCEDURE', 'description': 'Laparoscopy as treatment for ruptured ectopic pregnancy', 'armGroupLabels': ['Laparoscopy arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0001', 'city': 'Pretoria', 'state': 'Gauteng', 'country': 'South Africa', 'facility': 'Kalafong Academic Hospital', 'geoPoint': {'lat': -25.74486, 'lon': 28.18783}}], 'overallOfficials': [{'name': 'Leon C Snyman, MBChB FCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Principal Specialist, Department Obstetrics & Gynaecology, University of Pretoria'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pretoria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Leon Snyman', 'investigatorAffiliation': 'University of Pretoria'}}}}