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

November 8, 2015 updated by: Bernhard Dauser, MD, St John of God Hospital, Vienna
Fixation of mesh and peritoneal closure during TAPP repair using n-butyl cyanoacrylate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Steiermark
      • Graz, Steiermark, Austria, 8020
        • St John of God Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inguinal hernia,
  • femoral hernia

Exclusion Criteria:

  • pregnancy,
  • not able to understand patient information

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Inguinal herniation
In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.
Device: LiquiBandFix8
Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: During hospitalization and 6 weeks after surgery.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St John of God Hospital, Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

May 17, 2015

First Submitted That Met QC Criteria

May 28, 2015

First Posted (Estimate)

May 29, 2015

Study Record Updates

Last Update Posted (Estimate)

December 11, 2015

Last Update Submitted That Met QC Criteria

November 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StJohn

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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