Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-25 @ 10:29 PM
Study NCT ID:
NCT02998658
Status:
UNKNOWN
Last Update Posted:
2016-12-20
First Post:
2016-12-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2019-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-12-19', 'studyFirstSubmitDate': '2016-12-16', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suturing time of vaginal cuff', 'timeFrame': 'During hysterectomy operation'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'During hysterectomy operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Barbed sutures', 'Hysterectomy'], 'conditions': ['Hysterectomy']}, 'referencesModule': {'references': [{'pmid': '23680517', 'type': 'BACKGROUND', 'citation': 'Einarsson JI, Cohen SL, Gobern JM, Sandberg EM, Hill-Lydecker CI, Wang K, Brown DN. Barbed versus standard suture: a randomized trial for laparoscopic vaginal cuff closure. J Minim Invasive Gynecol. 2013 Jul-Aug;20(4):492-8. doi: 10.1016/j.jmig.2013.02.015. Epub 2013 May 14.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to estimate whether the use of the barbed suture facilitates laparoscopic suturing of the vaginal cuff during total laparoscopic hysterectomy.', 'detailedDescription': 'Vaginal cuff suturing is a significant step during hysterectomy with regard to operating time and a critical passage for the risk of vaginal cuff dehiscence. Vaginal cuff dehiscence is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (0.3-3.1 %) compared to abdominal and vaginal hysterectomy\n\nBarbed suture is a new type of sutures introduced to facilitate laparoscopic suturing.When compared with conventional smooth suture, barbed suture has external barbs that anchor the suture to the tissues and prevent the retrograde movement of suture thread during suturing. Consequently, laparoscopic suturing can be performed easily without the need for suture locking, without applying traction on suture thread by the assistant and without tying knots at both ends of the suture line In gynecology, barbed sutures have been used in minimally invasive ,myomectomy hysterectomy, ovarian cystectomy and sacrocolpopexy. There is a growing body of evidence that the use of barbed sutures in these procedures facilitates laparoscopic suturing and significantly reduces suturing time, total operating time and intraoperative blood loss To date only two small randomized controlled trials compared the effectiveness of the bidirectional knotless barbed suture versus standard suture in the repair of vaginal cuff'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with an indication for hysterectomy ( i.e. pain, bleeding and pressure symptoms)\n\nExclusion Criteria:\n\n* Genital malignancy\n* Uterine size more than 16 weeks\n* Coagulation defects or concurrent anticoagulant therapy\n* Pregnancy\n* Compromised cardiopulmonary status\n* Contraindications for general anesthesia'}, 'identificationModule': {'nctId': 'NCT02998658', 'briefTitle': 'Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Barbed Versus Conventional Sutures for Vaginal Cuff Closure During Total Laparoscopic Hysterectomy. A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Barbed/vaginal cuff'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vaginal cuff closure using barbed sutures', 'description': 'Vaginal cuff is closed with barbed sutures', 'interventionNames': ['Device: Vaginal cuff closure using barbed sutures']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal cuff closure using conventional sutures', 'description': 'Vaginal cuff is closed with conventional sutures', 'interventionNames': ['Device: Vaginal cuff closure using conventional sutures']}], 'interventions': [{'name': 'Vaginal cuff closure using barbed sutures', 'type': 'DEVICE', 'description': 'Vaginal cuff will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA )', 'armGroupLabels': ['Vaginal cuff closure using barbed sutures']}, {'name': 'Vaginal cuff closure using conventional sutures', 'type': 'DEVICE', 'description': 'Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .', 'armGroupLabels': ['Vaginal cuff closure using conventional sutures']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'country': 'Egypt', 'contacts': [{'name': 'Usama M. Fouda, Prof.', 'role': 'CONTACT', 'email': 'umfrfouda@yahoo.com'}], 'facility': 'Cairo university', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Usama M Fouda, Prof.', 'role': 'CONTACT', 'email': 'umfrfouda@yahoo.com'}, {'name': 'Khaled A Elsetohy,, Prof.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Usama M Fouda, Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department'}, {'name': 'Khaled A Elsetohy,, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo university ,Faculty of medicine , Obstetrics and Gynecology Department'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Usama M Fouda', 'investigatorAffiliation': 'Cairo University'}}}}