NCT02457728

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 17, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 29, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
4 months until next milestone

Results Posted

Study results publicly available

December 11, 2015

Completed
Last Updated

December 11, 2015

Status Verified

October 1, 2015

Enrollment Period

7 months

First QC Date

May 17, 2015

Results QC Date

August 16, 2015

Last Update Submit

November 8, 2015

Conditions

Hernia, Inguinal

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (1)

Inguinal herniation

EXPERIMENTAL

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

Interventions

LiquiBandFix8DEVICE

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

Inguinal herniation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Inguinal hernia,
  • femoral hernia

You may not qualify if:

  • pregnancy,
  • not able to understand patient information

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St John of God Hospital

Graz, Styria, 8020, Austria

Location

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Bernhard Dauser, MD, PhD
Organization
St John of God Hospital Vienna
b.dauser@hotmail.com
+4321121

Study Officials

  • Bernhard DAUSER, MD

    St John of God Hospital, Vienna

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 17, 2015

First Posted

May 29, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

December 11, 2015

Results First Posted

December 11, 2015

Record last verified: 2015-10

Locations

AU(1)