NCT01520168

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.

Trial Health

33
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Trial recruitment is currently suspended
Enrollment
21

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2003

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2003

Completed
7.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 27, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

March 13, 2012

Status Verified

March 1, 2012

Enrollment Period

7.8 years

First QC Date

January 24, 2012

Last Update Submit

March 12, 2012

Conditions

Incisional Hernia

Keywords

Incisional herniaMeshSurgeryComposix KugelIPOM technique

Outcome Measures

Primary Outcomes (1)

  • Early postoperative complications

    Assessment of postoperative complications (wound complication, mesh infection, seroma)

    6 months postoperative

Secondary Outcomes (1)

  • Long-term postoperative complications

    6 months to 5 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (\>18 years) with the diagnosis of symptomatic incisional hernia.

You may qualify if:

  • Age \> 18
  • Incisional hernia

You may not qualify if:

  • Younger than 18 years
  • Peritonitis
  • Intestinal fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General, Visceral, Vascular and Pediatric Surgery

Würzburg, Bavaria, 97080, Germany

Location

Related Publications (5)

  • 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: 20556448BACKGROUND

  • 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: 12424601BACKGROUND

  • 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: 19347564BACKGROUND

  • 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: 16211441BACKGROUND

  • 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.

    PMID: 21327906BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Explanted meshes

MeSH Terms

Conditions

Incisional Hernia

Condition Hierarchy (Ancestors)

HerniaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Study Officials

  • Ulrich A. Dietz, MD, PhD

    University of Wuerzburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Dr.

Study Record Dates

First Submitted

January 24, 2012

First Posted

January 27, 2012

Study Start

October 1, 2003

Primary Completion

July 1, 2011

Study Completion

March 1, 2012

Last Updated

March 13, 2012

Record last verified: 2012-03

Locations

DE(1)