Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management
This study has suspended participant recruitment.
(Because of the product recall 2005/2006.)
Sponsor:
University of Wuerzburg
Information provided by (Responsible Party):
PD Dr. Dr. Ulrich A. Dietz, University of Wuerzburg
ClinicalTrials.gov Identifier:
NCT01520168
First received: January 24, 2012
Last updated: March 12, 2012
Last verified: March 2012
| Tracking Information | |||||
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| First Received Date ICMJE | January 24, 2012 | ||||
| Last Updated Date | March 12, 2012 | ||||
| Start Date ICMJE | October 2003 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Early postoperative complications [ Time Frame: 6 months postoperative ] [ Designated as safety issue: Yes ] Assessment of postoperative complications (wound complication, mesh infection, seroma) |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01520168 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Long-term postoperative complications [ Time Frame: 6 months to 5 years ] [ Designated as safety issue: Yes ] Chronic pain, chronic and recurrent mesh infection, mesh bulging, incisional hernia and intestinal fistula |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management | ||||
| Official Title ICMJE | The 2005 Composix Kugel Mesh Recall Leaves Unresolved Problems of Patient Management: Taking Stock After 5-year Follow up | ||||
| Brief Summary | 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. The 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. |
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| Detailed Description | 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples Without DNA Description: Explanted meshes |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult patients (>18 years) with the diagnosis of symptomatic incisional hernia. |
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| Condition ICMJE | Incisional Hernia | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Suspended | ||||
| Enrollment ICMJE | 21 | ||||
| Estimated Completion Date | March 2012 | ||||
| Primary Completion Date | July 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01520168 | ||||
| Other Study ID Numbers ICMJE | UD 069/11 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | PD Dr. Dr. Ulrich A. Dietz, University of Wuerzburg | ||||
| Study Sponsor ICMJE | University of Wuerzburg | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wuerzburg | ||||
| Verification Date | March 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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