3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 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: May 19, 2014
Last verified: May 2014
  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
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(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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 19, 2014
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

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

ClinicalTrials.gov processed this record on October 23, 2014