Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT05833204
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-04-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "The surgeon will not be blinded. Conversely, patients and co-investigators who will assess study outcomes and perform patients' follow-ups will be masked regarding the allocation arm until the study's conclusion."}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Multicenter, parallel arms, open-label, randomized controlled trial.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1614}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-27', 'studyFirstSubmitDate': '2023-04-01', 'studyFirstSubmitQcDate': '2023-04-15', 'lastUpdatePostDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vaginal cuff dehiscence', 'timeFrame': '30 days after surgery', 'description': 'Any partial or total separation of the vaginal cuff'}, {'measure': 'Vaginal cuff dehiscence', 'timeFrame': '90 days after surgery', 'description': 'Any partial or total separation of the vaginal cuff'}], 'secondaryOutcomes': [{'measure': 'Vaginal cuff complications', 'timeFrame': '30 days after surgery', 'description': 'Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff'}, {'measure': 'Vaginal cuff complications', 'timeFrame': '90 days after surgery', 'description': 'Hematoma, abscess, infections, bleeding, resuture of the vaginal cuff'}, {'measure': 'Hospital stay', 'timeFrame': 'From the date of hospital admission to the date of hospital discharge.', 'description': 'Days of hospitalization from the day of admission to the day of discharge.'}, {'measure': 'Operative time', 'timeFrame': 'During surgery', 'description': 'Time between first incision and skin closure'}, {'measure': 'Intraoperative blood loss', 'timeFrame': 'During surgery', 'description': 'Total blood aspirate during the surgical procedure'}, {'measure': '30-day post-surgical morbidity', 'timeFrame': '30 days after surgery', 'description': 'Perioperative (intraoperative and postoperative) complications graded based on the Clavien-Dindo classification'}, {'measure': 'Quality of life index', 'timeFrame': '90 days after surgery', 'description': 'The Short Form 12 Health Survey (SF-12) investigates 8 different health aspects. Physical activity, role and physical health, role and emotional state, and mental health are measured by two questions. The SF-12 scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.'}, {'measure': 'Sexual function', 'timeFrame': '90 days after surgery', 'description': 'The female sexual function index (FSFI) consists of 19 multiple-choice items that assess female sexual functioning based on 6 domains: desire, arousal, orgasm, pain, sexual satisfaction, and lubrication. The total score ranges from 0 to 36, with 26.55 as the cut-off suggesting the presence of sexual dysfunction. The higher the score, the better the sexual function.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Hysterectomy', 'Vaginal cuff closure', 'Barbed sutures', 'Vaginal cuff complications', 'Vaginal cuff dehiscence'], 'conditions': ['Vaginal Cuff Complications']}, 'referencesModule': {'references': [{'pmid': '33348012', 'type': 'BACKGROUND', 'citation': 'Uccella S, Zorzato PC, Kho RM. Incidence and Prevention of Vaginal Cuff Dehiscence after Laparoscopic and Robotic Hysterectomy: A Systematic Review and Meta-analysis. J Minim Invasive Gynecol. 2021 Mar;28(3):710-720. doi: 10.1016/j.jmig.2020.12.016. Epub 2021 Jan 5.'}, {'pmid': '29410107', 'type': 'BACKGROUND', 'citation': 'Uccella S, Malzoni M, Cromi A, Seracchioli R, Ciravolo G, Fanfani F, Shakir F, Gueli Alletti S, Legge F, Berretta R, Corrado G, Casarella L, Donarini P, Zanello M, Perrone E, Gisone B, Vizza E, Scambia G, Ghezzi F. Laparoscopic vs transvaginal cuff closure after total laparoscopic hysterectomy: a randomized trial by the Italian Society of Gynecologic Endoscopy. Am J Obstet Gynecol. 2018 May;218(5):500.e1-500.e13. doi: 10.1016/j.ajog.2018.01.029. Epub 2018 Feb 2.'}]}, 'descriptionModule': {'briefSummary': 'Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Among potentially life-threatening events, vaginal cuff dehiscence complicates 0.14-1.38% of procedures, and any vaginal cuff complications (dehiscence, hematoma, bleeding, infection) are estimated to affect 4.7-9.8% of patients. In this scenario, any preventive strategy can provide clinically relevant benefits. Regarding colporrhaphy, only the adoption of a laparoscopic approach instead of a vaginal approach is supported by high-quality evidence. Our group demonstrated that the laparoscopic closure of the vaginal cuff after total laparoscopic hysterectomy reduces the incidence of vaginal cuff complications.\n\nAmong other potentially effective interventions, the use of barbed sutures was associated with a lower incidence of vaginal cuff dehiscence than the standard suture. In a recent meta-analysis, the use of barbed sutures has been associated with a pooled incidence of vaginal cuff dehiscence of 0.4% versus 2% after a traditional vaginal suture. However, this evidence is limited because most pooled studies were retrospective, and only two were randomized controlled trials. Moreover, these two randomized controlled trials had a very small sample size and were not powered to detect clinically relevant differences. On that basis, despite the promising utility of barbed sutures for vaginal cuff closure after total laparoscopic hysterectomy, the choice of the type of suture is not evidence-based but still guided by personal opinions, as well as by the preference and habits of the operators.\n\nTherefore, this study aims to investigate whether the laparoscopic vaginal cuff closure with barbed suture determines a lower incidence of vaginal cuff dehiscence and complications than conventional sutures after total laparoscopic hysterectomy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing elective total laparoscopic hysterectomy\n* Surgery performed for the treatment of benign pathology\n* Age \\> 18 years\n* Surgery performed by laparoscopy\n* Signature of informed consent\n\nExclusion Criteria:\n\n* Patients undergoing emergent surgery\n* Patients candidates for hysterectomy for oncological indication\n* Patients who underwent previous radiation therapy\n* Patients allergic to the suture material used in the study\n* Patients unable to express adequate informed consent to participate in the study'}, 'identificationModule': {'nctId': 'NCT05833204', 'acronym': 'BARD', 'briefTitle': 'BARBED vs. STANDARD Suture for Colporrhaphy at the End of Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Universita di Verona'}, 'officialTitle': 'Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BARD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colporrhaphy with barbed absorbable suture', 'description': 'The colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)', 'interventionNames': ['Procedure: Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Colporrhaphy with standard absorbable suture', 'description': 'The colporrhaphy will be performed using a standard 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ)', 'interventionNames': ['Procedure: Laparoscopic colporrhaphy with standard 0-caliber absorbable suture']}], 'interventions': [{'name': 'Laparoscopic colporrhaphy with 0-caliber barbed absorbable suture', 'type': 'PROCEDURE', 'description': 'After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber barbed absorbable suture (V-Loc ™, Covidien, Medtronic)', 'armGroupLabels': ['Colporrhaphy with barbed absorbable suture']}, {'name': 'Laparoscopic colporrhaphy with standard 0-caliber absorbable suture', 'type': 'PROCEDURE', 'description': 'After the total laparoscopic hysterectomy, the colporrhaphy will be performed using a 0-caliber absorbable suture made of a coated braided thread (Vicryl; Ethicon Inc, Sommerville, NJ)', 'armGroupLabels': ['Colporrhaphy with standard absorbable suture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37125', 'city': 'Verona', 'country': 'Italy', 'facility': 'AOUI Verona - University of Verona - Department of Obstetrics and Gynecology', 'geoPoint': {'lat': 45.43854, 'lon': 10.9938}}], 'centralContacts': [{'name': 'Stefano Uccella, MD, PhD', 'role': 'CONTACT', 'email': 'stefano.uccella@univr.it', 'phone': '0039 045 812 2720'}, {'name': 'Simone Garzon, MD', 'role': 'CONTACT', 'email': 'simone.garzon@univr.it', 'phone': '0039 045 812 2720'}], 'overallOfficials': [{'name': 'Stefano Uccella, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita di Verona'}, {'name': 'Simone Garzon, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita di Verona'}, {'name': 'Pier Carlo Zorzato, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universita di Verona'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita di Verona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Stefano Uccella', 'investigatorAffiliation': 'Universita di Verona'}}}}