Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-27 @ 9:01 AM
Study NCT ID:
NCT01520168
Status:
SUSPENDED
Last Update Posted:
2012-03-13
First Post:
2012-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000069290', 'term': 'Incisional Hernia'}], 'ancestors': [{'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Explanted meshes'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'whyStopped': 'Because of the product recall 2005/2006.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2012-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-03-12', 'studyFirstSubmitDate': '2012-01-24', 'studyFirstSubmitQcDate': '2012-01-26', 'lastUpdatePostDateStruct': {'date': '2012-03-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early postoperative complications', 'timeFrame': '6 months postoperative', 'description': 'Assessment of postoperative complications (wound complication, mesh infection, seroma)'}], 'secondaryOutcomes': [{'measure': 'Long-term postoperative complications', 'timeFrame': '6 months to 5 years', 'description': 'Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Incisional hernia', 'Mesh', 'Surgery', 'Composix Kugel', 'IPOM technique'], 'conditions': ['Incisional Hernia']}, 'referencesModule': {'references': [{'pmid': '20556448', 'type': 'BACKGROUND', 'citation': 'Muysoms FE, Bontinck J, Pletinckx P. Complications of mesh devices for intraperitoneal umbilical hernia repair: a word of caution. Hernia. 2011 Aug;15(4):463-8. doi: 10.1007/s10029-010-0692-x. Epub 2010 Jun 17.'}, {'pmid': '12424601', 'type': 'BACKGROUND', 'citation': 'LeBlanc KA, Whitaker JM. Management of chronic postoperative pain following incisional hernia repair with Composix mesh: a report of two cases. Hernia. 2002 Dec;6(4):194-7. doi: 10.1007/s10029-002-0075-z. Epub 2002 Sep 11.'}, {'pmid': '19347564', 'type': 'BACKGROUND', 'citation': 'Hope WW, Iannitti DA. An algorithm for managing patients who have Composix Kugel ventral hernia mesh. Hernia. 2009 Oct;13(5):475-9. doi: 10.1007/s10029-009-0498-x. Epub 2009 Apr 4.'}, {'pmid': '16211441', 'type': 'BACKGROUND', 'citation': 'Robinson TN, Clarke JH, Schoen J, Walsh MD. Major mesh-related complications following hernia repair: events reported to the Food and Drug Administration. Surg Endosc. 2005 Dec;19(12):1556-60. doi: 10.1007/s00464-005-0120-y. Epub 2005 Oct 5.'}, {'pmid': '21327906', 'type': 'BACKGROUND', 'citation': 'Dietz UA, Spor L, Germer CT. [Management of mesh-related infections]. Chirurg. 2011 Mar;82(3):208-17. doi: 10.1007/s00104-010-2013-4. German.'}], 'seeAlsoLinks': [{'url': 'http://www.zom-wuerzburg.de/index.php?id=236', 'label': 'Research page of the Department'}]}, 'descriptionModule': {'briefSummary': 'From its introduction in 2000 until its US recall in December 2005, the Composix Kugel Mesh was implanted in an estimated 350,000 patients worldwide.\n\nThe purpose of the study is to evaluate retrospectively the complications related to this mesh that occurred in our patients between 2003 and 2005, since new complications continue to be diagnosed, although the investigators discontinued the use of the mesh.', 'detailedDescription': 'From 2003 to 2005(2006) we implanted Komposix Kugel Meshes in 21 Patients with incisional ventral hernias. With the recall of January 2006 (in Germany), we stopped the implantation of this mesh and continued to monitor the patients with follow up and phone interviews. Late complications still continue to occur, mainly as a consequence of the product defect identified 7 years ago.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (\\>18 years) with the diagnosis of symptomatic incisional hernia.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18\n* Incisional hernia\n\nExclusion Criteria:\n\n* Younger than 18 years\n* Peritonitis\n* Intestinal fistula'}, 'identificationModule': {'nctId': 'NCT01520168', 'briefTitle': 'Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management', 'organization': {'class': 'OTHER', 'fullName': 'University of Wuerzburg'}, 'officialTitle': 'The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up', 'orgStudyIdInfo': {'id': 'UD 069/11'}}, 'contactsLocationsModule': {'locations': [{'zip': '97080', 'city': 'Würzburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Department of General, Visceral, Vascular and Pediatric Surgery', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}], 'overallOfficials': [{'name': 'Ulrich A. Dietz, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wuerzburg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wuerzburg', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. Dr.', 'investigatorFullName': 'PD Dr. Dr. Ulrich A. Dietz', 'investigatorAffiliation': 'University of Wuerzburg'}}}}