Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT00773851
Status:
COMPLETED
Last Update Posted:
2023-11-02
First Post:
2008-10-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006555', 'term': 'Hernia, Ventral'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-01', 'studyFirstSubmitDate': '2008-10-15', 'studyFirstSubmitQcDate': '2008-10-15', 'lastUpdatePostDateStruct': {'date': '2023-11-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-10-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mesh shrinkage', 'timeFrame': 'perioperative, 6 weeks, 6 months postoperative'}], 'secondaryOutcomes': [{'measure': 'mesh dislocation', 'timeFrame': 'perioperative, 6 weeks postoperative,6 months postoperative'}, {'measure': 'pain', 'timeFrame': 'perioperative, 6 weeks postoperative,6 months, 12 moths postoperative'}, {'measure': 'recurrence', 'timeFrame': 'perioperative, 6 weeks postoperative,6 months, 12 months postoperative'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ventral hernia', 'laparoscopy', 'mesh', 'recurrence'], 'conditions': ['Ventral Hernia', 'Pain']}, 'referencesModule': {'references': [{'pmid': '14501505', 'type': 'BACKGROUND', 'citation': "Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab."}, {'pmid': '14634842', 'type': 'BACKGROUND', 'citation': 'Borrazzo EC, Belmont MF, Boffa D, Fowler DL. Effect of prosthetic material on adhesion formation after laparoscopic ventral hernia repair in a porcine model. Hernia. 2004 May;8(2):108-12. doi: 10.1007/s10029-003-0181-6. Epub 2003 Nov 21.'}, {'pmid': '12098028', 'type': 'BACKGROUND', 'citation': "van't Riet M, de Vos van Steenwijk PJ, Kleinrensink GJ, Steyerberg EW, Bonjer HJ. Tensile strength of mesh fixation methods in laparoscopic incisional hernia repair. Surg Endosc. 2002 Dec;16(12):1713-6. doi: 10.1007/s00464-001-9202-7. Epub 2002 Jul 8."}, {'pmid': '14752650', 'type': 'BACKGROUND', 'citation': 'Winslow ER, Diaz S, Desai K, Meininger T, Soper NJ, Klingensmith ME. Laparoscopic incisional hernia repair in a porcine model: what do transfixion sutures add? Surg Endosc. 2004 Mar;18(3):529-35. doi: 10.1007/s00464-003-8519-9. Epub 2004 Feb 2.'}, {'pmid': '11510590', 'type': 'BACKGROUND', 'citation': 'LeBlanc KA. The critical technical aspects of laparoscopic repair of ventral and incisional hernias. Am Surg. 2001 Aug;67(8):809-12.'}, {'pmid': '12399849', 'type': 'BACKGROUND', 'citation': 'Carbajo MA, Martp del Olmo JC, Blanco JI, Toledano M, de la Cuesta C, Ferreras C, Vaquero C. Laparoscopic approach to incisional hernia. Surg Endosc. 2003 Jan;17(1):118-22. doi: 10.1007/s00464-002-9079-0. Epub 2002 Oct 29.'}, {'pmid': '12811619', 'type': 'BACKGROUND', 'citation': 'Chelala E, Gaede F, Douillez V, Dessily M, Alle JL. The suturing concept for laparoscopic mesh fixation in ventral and incisional hernias: preliminary results. Hernia. 2003 Dec;7(4):191-6. doi: 10.1007/s10029-003-0143-z. Epub 2003 Jun 13.'}, {'pmid': '14626408', 'type': 'BACKGROUND', 'citation': 'LeBlanc KA. Tack hernia: a new entity. JSLS. 2003 Oct-Dec;7(4):383-7.'}, {'pmid': '9565117', 'type': 'BACKGROUND', 'citation': 'Leber GE, Garb JL, Alexander AI, Reed WP. Long-term complications associated with prosthetic repair of incisional hernias. Arch Surg. 1998 Apr;133(4):378-82. doi: 10.1001/archsurg.133.4.378.'}, {'pmid': '14648721', 'type': 'BACKGROUND', 'citation': 'Schumpelick V, Klinge U. Prosthetic implants for hernia repair. Br J Surg. 2003 Dec;90(12):1457-8. doi: 10.1002/bjs.4385. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Hernia of the abdominal wall occur frequently after various surgical procedures of the abdomen and are increasingly performed by laparoscopic means. Different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients. Therefore, mesh shrinkage was assessed using two different techniques for fixation.', 'detailedDescription': 'Ventral hernia repair is increasingly performed by laparoscopic means. While mesh ingrowth and shrink-age has been analysed in the experimental setting, there is scarce data available in humans. In addition, different mesh fixation techniques are applied, but the influence of mesh fixation on shrinkage is not known in human patients.\n\nMesh shrinkage is assessed using two different techniques for fixation.\n\nBlinded randomized trial using a Parietene composite mesh for laparoscopic ventral hernia repair. Patients with ventral hernias of no larger than 8 cm were assigned to either mesh fixation using transfacial nonabsorbable sutures or titan tacks. Primary endpoint was mesh migration, secondary endpoints were mesh shrinkage, surgical morbidity and pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with incisional hernia smaller than 8cm in diameter\n* obtained informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Residual intraperitoneal mesh\n* contaminated abdominal cavity\n* longterm use of corticosteroids and other immunosuppressive agents\n* bodymass index \\> 45\n* general contradictions for laparoscopy'}, 'identificationModule': {'nctId': 'NCT00773851', 'briefTitle': 'Transfacial Sutures Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medtronic - MITG'}, 'officialTitle': 'Mesh Shrinkage Following Transfacial Suturing Versus Stapler for Mesh Fixation in Laparoscopic Ventral Hernia Repair: a Prospective, Randomised Blinded Study', 'orgStudyIdInfo': {'id': 'KEK_11/05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'A', 'description': 'transfacial sutures', 'interventionNames': ['Procedure: mesh fixation by transfacial sutures']}, {'type': 'OTHER', 'label': 'B', 'description': 'staples', 'interventionNames': ['Procedure: mesh fixation by staples']}], 'interventions': [{'name': 'mesh fixation by transfacial sutures', 'type': 'PROCEDURE', 'description': 'mesh fixation by transfacial sutures', 'armGroupLabels': ['A']}, {'name': 'mesh fixation by staples', 'type': 'PROCEDURE', 'description': 'mesh fixation by staples', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Dep. of Visceral and Transplantsurgery, Bern University Hospital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}], 'overallOfficials': [{'name': 'Guido1 Beldi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bern University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medtronic - MITG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sofradim Production', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}