3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)

This study is currently recruiting participants.
Verified August 2013 by Horsens Hospital
Sponsor:
Collaborator:
Randers Regional Hospital
Information provided by (Responsible Party):
Hans Friis-Andersen, Horsens Hospital
ClinicalTrials.gov Identifier:
NCT01534780
First received: February 9, 2012
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

Clinical, controlled, randomized, prospective study. Ventral hernias between 2cm 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
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, 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 Horsens Hospital:

Primary Outcome Measures:
  • Pain [ Time Frame: 1 measurement, 2nd postoperative day ] [ Designated as safety issue: No ]
    Dolo Test (VAS)


Secondary Outcome Measures:
  • hernia recurrence [ Time Frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
    clinical examination and perhaps CT scan

  • quality of life [ Time Frame: 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 ] [ Designated as safety issue: No ]
    SF 36 and Carolina's Comfort Scale

  • adhesions [ Time Frame: 1 measurement, at 24 month ] [ Designated as safety issue: No ]
    MR scan

  • Pain [ Time Frame: 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ventral hernia 2 < 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Hans Friis-Andersen, Principal Investigator, Horsens Hospital
ClinicalTrials.gov Identifier: NCT01534780     History of Changes
Other Study ID Numbers: KIR-001-HRH
Study First Received: February 9, 2012
Last Updated: August 27, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on April 17, 2014