Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-02 @ 6:59 AM
Study NCT ID:
NCT01984632
Status:
COMPLETED
Last Update Posted:
2015-07-31
First Post:
2013-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Barbed Suture in Single-port Laparoscopic Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-30', 'studyFirstSubmitDate': '2013-11-03', 'studyFirstSubmitQcDate': '2013-11-14', 'lastUpdatePostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suturing time', 'timeFrame': 'Intra-operative', 'description': 'the time duration for the suture of uterine wall defect after myoma enucleation during laparoscopic myomectomy'}], 'secondaryOutcomes': [{'measure': 'Cosmetic satisfaction', 'timeFrame': 'Post-surgery 1 month and 3 month', 'description': "We will compare patient's cosmetic satisfaction through self-reported questionnaire (Body image Questionnaire)."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Uterine Myoma']}, 'referencesModule': {'references': [{'pmid': '26263079', 'type': 'DERIVED', 'citation': 'Song T, Kim TJ, Lee SH, Kim TH, Kim WY. Laparoendoscopic single-site myomectomy compared with conventional laparoscopic myomectomy: a multicenter, randomized, controlled trial. Fertil Steril. 2015 Nov;104(5):1325-31. doi: 10.1016/j.fertnstert.2015.07.1137. Epub 2015 Aug 8.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to test our hypothesis that the use of unidirectional knotless barbed suture in single-port laparoscopic myomectomy could facilitate the suture of uterine wall defect after myoma enucleation as multi-port laparoscopic myomectomy did.', 'detailedDescription': 'The investigators plan to perform a multi-center randomized clinical trial on women scheduled for laparoscopic myomectomy. All women will get the same preoperative and postoperative care. Women will be assigned by chance to one of two groups: one group will receive single-port laparoscopic myomectomy using V-Loc™ suture material (study group). The other group will receive conventional multi-port laparoscopic myomectomy using V-Loc™ suture material (control group). The investigators will collect information on suturing time and complications related to surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 55 years\n* Image-confirmed uterine myoma\n* Number of myoma ≤2 and largest size ≤10cm\n* Women who were scheduled to have laparoscopic myomectomy\n* Appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status classification 1 or 2)\n\nExclusion Criteria:\n\n* Women with pedunculated subserosal myoma or submucosal myoma\n* Women undergoing concomitant complex surgical procedures at the time of laparoscopic myomectomy such as severe adhesiolysis or resection for severe endometriosis\n* Women with any suggestion of malignant uterine or adnexal diseases\n* Women with diabetics, malignancy, or malnutrition, which can affect wound healing\n* Women having major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance\n* Women who refuse to participate or give consent to the procedures'}, 'identificationModule': {'nctId': 'NCT01984632', 'briefTitle': 'Barbed Suture in Single-port Laparoscopic Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'CHA University'}, 'officialTitle': 'Single-port Laparoscopic Myomectomy Using Barbed Suture Versus Multi-port One: a Multi-center Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MYO04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single-port laparoscopic myomectomy', 'description': 'We will use barbed suture (V-Loc) under intervention of single-port laparoscopic myomectomy', 'interventionNames': ['Procedure: Single-port laparoscopic myomectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Multi-port laparoscopic myomectomy', 'description': 'We will use barbed suture(V-Loc) under intervention of multi-port laparoscopic myomectomy.', 'interventionNames': ['Procedure: Multi-port laparoscopic myomectomy']}], 'interventions': [{'name': 'Single-port laparoscopic myomectomy', 'type': 'PROCEDURE', 'description': 'The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time).', 'armGroupLabels': ['Single-port laparoscopic myomectomy']}, {'name': 'Multi-port laparoscopic myomectomy', 'type': 'PROCEDURE', 'description': 'The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time).', 'armGroupLabels': ['Multi-port laparoscopic myomectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Goyang', 'country': 'South Korea', 'facility': 'National Health Insurance Service Ilsan Hospital', 'geoPoint': {'lat': 36.21689, 'lon': 127.19731}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'CHA Gangnam Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Kangbuk Samsung Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Taejong Song, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHA Gangnam Medical Center, CHA university, Seoul, Republic of Korea'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHA University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Taejong Song', 'investigatorAffiliation': 'CHA University'}}}}