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3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)

This study is currently recruiting participants.
Verified February 2016 by Hans Friis-Andersen, Horsens Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01534780
First Posted: February 17, 2012
Last Update Posted: February 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Randers Regional Hospital
Information provided by (Responsible Party):
Hans Friis-Andersen, Horsens Hospital
  Purpose

Clinical, controlled, randomized, prospective study. Ventral hernias between 2(1.5)cm and 7 cm, laparoscopic surgery with intraperitoneal onlay mesh.

Three randomization groups of 25 patients giving a total of 75 patients. Mesh is fixated with either Protack, Securestrap or Glubran II. Primary outcome: postoperative pain on the 2nd postoperative day. Secondary outcomes: pain, quality of life, recurrence and adhesions at 1, 6, 12, 24, 36, 48 and 60 months postoperative.


Condition Intervention Phase
Ventral Hernia Procedure: laparoscopic ventral herniotomy Device: Protack Device: Securestrap Device: Glubran Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy

Resource links provided by NLM:


Further study details as provided by Hans Friis-Andersen, Horsens Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 1 measurement, 2nd postoperative day ]
    Dolo Test (VAS)


Secondary Outcome Measures:
  • hernia recurrence [ Time Frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 ]
    clinical examination and perhaps CT scan

  • quality of life [ Time Frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 ]
    SF 36 and Carolina's Comfort Scale

  • Pain [ Time Frame: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24 ]
    Dolo Test(VAS)


Estimated Enrollment: 75
Study Start Date: April 2013
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: fixation with Protack Procedure: laparoscopic ventral herniotomy
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
Other Name: no other names
Device: Protack
fixation of mesh with protack
Experimental: fixation with Securestrap Procedure: laparoscopic ventral herniotomy
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
Other Name: no other names
Device: Securestrap
fixation of mesh with Securestrap
Experimental: fixation with Glubran
surgery
Procedure: laparoscopic ventral herniotomy
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
Other Name: no other names
Device: Glubran
fixation of mesh with Glubran

Detailed Description:
see brief summary
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ventral hernia 2(1,5) < dia > 7 cm
  • danish speaking
  • of sound mind
  • bmi < 35
  • ASA 3 or less, no contra indication against laparoscopy

Exclusion Criteria:

  • other size hernias,
  • no danish,
  • bmi > 35
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01534780


Locations
Denmark
Regional Hospital Horsens Recruiting
Horsens, Denmark, 8700
Contact: Hans Friis Andersen, MD    0045 78426222    hans.friis@horsens.rm.dk   
Principal Investigator: Hans Friis Andersen, MD         
Sponsors and Collaborators
Horsens Hospital
Randers Regional Hospital
Investigators
Study Chair: Sanne S Harsløf, MD Horsens Regional Hospital
Study Director: Thorbjørn Sommer, MD, PhD Randers Regional Hospital
  More Information

Responsible Party: Hans Friis-Andersen, Principal Investigator, Horsens Hospital
ClinicalTrials.gov Identifier: NCT01534780     History of Changes
Other Study ID Numbers: KIR-001-HRH
First Submitted: February 9, 2012
First Posted: February 17, 2012
Last Update Posted: February 19, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Hernia, Ventral
Hernia, Abdominal
Hernia
Pathological Conditions, Anatomical