search
Back to results

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

Primary Purpose

Hernia, Inguinal

Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
LiquiBandFix8
Sponsored by
St John of God Hospital, Vienna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hernia, Inguinal

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Inguinal hernia,
  • femoral hernia

Exclusion Criteria:

  • pregnancy,
  • not able to understand patient information

Sites / Locations

  • St John of God Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Inguinal herniation

Arm Description

In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 17, 2015
Last Updated
November 8, 2015
Sponsor
St John of God Hospital, Vienna
search

1. Study Identification

Unique Protocol Identification Number
NCT02457728
Brief Title
Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
Official Title
Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St John of God Hospital, Vienna

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Inguinal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Inguinal herniation
Arm Type
Experimental
Arm Description
In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.
Intervention Type
Device
Intervention Name(s)
LiquiBandFix8
Intervention Description
Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
During hospitalization and 6 weeks after surgery.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inguinal hernia, femoral hernia Exclusion Criteria: pregnancy, not able to understand patient information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernhard DAUSER, MD
Organizational Affiliation
St John of God Hospital, Vienna
Official's Role
Principal Investigator
Facility Information:
Facility Name
St John of God Hospital
City
Graz
State/Province
Steiermark
ZIP/Postal Code
8020
Country
Austria

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs