Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2025-12-29 @ 8:18 AM
Study NCT ID:
NCT02308995
Status:
UNKNOWN
Last Update Posted:
2016-01-29
First Post:
2014-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-01-28', 'studyFirstSubmitDate': '2014-12-03', 'studyFirstSubmitQcDate': '2014-12-04', 'lastUpdatePostDateStruct': {'date': '2016-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suturing time of endometrioma bed', 'timeFrame': 'During cystectomy operation'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'During cystectomy operation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Endometriosis', 'Laparoscopy', 'Barbed sutures'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.', 'detailedDescription': 'Several authors reported the use of barbed sutures in myomectomy , hysterectomy and closure of vaginal vault. A recent meta-analysis comparing the efficacy of laparoscopic suturing using barbed suture or conventional sutures in myomectomy or hysterectomy revealed that suturing with barbed sutures was associated with less suturing time and operative time.\n\nAlthough numerous studies revealed the advantages of using barbed sutures , no studies have yet evaluated the use of barbed sutures in laparoscopic excision of endometrioma.\n\nThe aim of this randomized controlled trial is to compare operative data and early postoperative outcomes of laparoscopic excision of endometrioma using barbed sutures with those of laparoscopic excision of endometrioma using conventional sutures.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral endometrioma more than 3 cm in mean diameter\n\nExclusion Criteria:\n\n* Bilateral endometriomata\n* Conversion of laparoscopy to laparotomy\n* Contraindications for general anesthesia'}, 'identificationModule': {'nctId': 'NCT02308995', 'briefTitle': 'Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma', 'organization': {'class': 'OTHER', 'fullName': 'Aljazeera Hospital'}, 'officialTitle': 'Barbed Sutures Versus Conventional Sutures in Laparoscopic Excision of Endometrioma . A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'lap.cystectomy.barbed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cystectomy using barbed sutures', 'description': 'Endometrioma bed is sutured with barbed sutures', 'interventionNames': ['Procedure: Cystectomy using barbed sutures', 'Device: V-Loc (Covidien, Mansfield, MA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cystectomy using conventional sutures', 'description': 'Endometrioma bed is sutured with conventional sutures', 'interventionNames': ['Procedure: Cystectomy using conventional sutures', 'Device: polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)']}], 'interventions': [{'name': 'Cystectomy using barbed sutures', 'type': 'PROCEDURE', 'description': 'A sharp transverse cortical incision was made over the endometroma using unipolar hook and a cleavage plane was developed by sharp dissection. After the identification of the cleavage plane, the entire cyst will be enucleated by means of adequate traction with a strong grasper and counter-traction maneuvers with another grasping forceps . The ovarian edges will be re-approximated by using V-Loc (Covidien, Mansfield, MA).', 'armGroupLabels': ['Cystectomy using barbed sutures']}, {'name': 'Cystectomy using conventional sutures', 'type': 'PROCEDURE', 'description': 'A sharp transverse cortical incision was made over the endometroma using unipolar hook and a cleavage plane was developed by sharp dissection. After the identification of the cleavage plane, the entire cyst will be enucleated by means of adequate traction with a strong grasper and counter-traction maneuvers with another grasping forceps . The ovarian edges will be re-approximated by using polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .', 'armGroupLabels': ['Cystectomy using conventional sutures']}, {'name': 'V-Loc (Covidien, Mansfield, MA)', 'type': 'DEVICE', 'armGroupLabels': ['Cystectomy using barbed sutures']}, {'name': 'polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)', 'type': 'DEVICE', 'armGroupLabels': ['Cystectomy using conventional sutures']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'state': 'Giza Governorate', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Usama M. Fouda, M.D, PhD', 'role': 'CONTACT', 'email': 'umfrfouda@yahoo.com', 'phone': '01095401375', 'phoneExt': '+2'}, {'name': 'Usama M. Fouda, M.D, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Aljazeera hospital', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}], 'centralContacts': [{'name': 'Usama M Fouda, M.D,PhD', 'role': 'CONTACT', 'email': 'umfrfouda@yahoo.com', 'phone': '01095401375', 'phoneExt': '+2'}], 'overallOfficials': [{'name': 'Usama M Fouda, M.D,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Aljazeera Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aljazeera Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D, PhD', 'investigatorFullName': 'Prof .Usama M.Fouda', 'investigatorAffiliation': 'Aljazeera Hospital'}}}}