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

NCT ID: NCT02457728

Last Updated: 2015-12-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hernia, Inguinal

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

LiquiBandFix8

Intervention Type DEVICE

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

Interventions

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LiquiBandFix8

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Inguinal hernia,
* femoral hernia

Exclusion Criteria

* pregnancy,
* not able to understand patient information
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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St John of God Hospital, Vienna

OTHER

Sponsor Role lead

Responsible Party

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Bernhard Dauser, MD

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bernhard DAUSER, MD

Role: PRINCIPAL_INVESTIGATOR

St John of God Hospital, Vienna

Locations

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St John of God Hospital

Graz, Styria, Austria

Site Status

Countries

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Austria

Other Identifiers

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StJohn

Identifier Type: -

Identifier Source: org_study_id