Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate

Hernia, Inguinal Clinical Trial

Official title:

Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02457728
• Other study ID #: StJohn
• Status: Completed
• Phase: N/A
• First received: May 17, 2015
• Last updated: November 8, 2015
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: St John of God Hospital, Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial Summary

Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.

Description:

During transabdominal pre peritoneal (TAPP) hernia repair a mesh should be fixed at four pre-determined points. Number of attempts to fix the mesh with a novel non-penetrating fixation device (LiquiBandFix8) will be recorded. This novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors).

In addition, closure of peritoneum should be accomplished using this device.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Inguinal hernia,

• femoral hernia

Exclusion Criteria:

• pregnancy,

• not able to understand patient information

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Device:
• LiquiBandFix8
Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.

Locations

Country	Name	City	State
Austria	St John of God Hospital	Graz	Steiermark

Sponsors (1)

Lead Sponsor	Collaborator
St John of God Hospital, Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks Postoperatively.	Clinical examination during hospital stay to rule out any bowel obstruction due to insufficient closure of peritoneum. Telephone interview at six weeks postoperatively to record any adverse events in the early postoperative period such as recurrent hernia, pain or bowel obstruction.	During hospitalization and 6 weeks after surgery.	No