3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)
This study is not yet open for participant recruitment.
Verified March 2012 by Horsens Hospital
Sponsor:
Horsens Hospital
Collaborator:
Randers Region Hospital
Information provided by (Responsible Party):
Hans Friis-Andersen, Horsens Hospital
ClinicalTrials.gov Identifier:
NCT01534780
First received: February 9, 2012
Last updated: March 1, 2012
Last verified: March 2012
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Purpose
75 patients with ventral hernias between 2 and 7 cm in diameter are operated laparoscopically with intraperitoneal onlay mesh. Fixation of mesh is performed with either Protack, Securestrap or Glubran after randomization, 25 in each group and blocks of 15. Primary outcomes are postoperative pain and quality of life measured with VAS, SF-36, Dolo-Test and Carolinas Comfort Scale. Secondary outcomes are recurrence, surgical complications and adhesion formation (MRI).
| 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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
Further study details as provided by Horsens Hospital:
Primary Outcome Measures:
- Pain [ Time Frame: 12 measurements from day 1 to year 2,(day 1-3, 14 and after 1, 6, 12, 24, 36, 48, 60 months) ] [ Designated as safety issue: No ]VAS score
Secondary Outcome Measures:
- hernia recurrence [ Time Frame: 4 measurements, 2, 3, 4 and 5 years after surgery ] [ Designated as safety issue: No ]clinical examination and perhaps CT scan
| Estimated Enrollment: | 75 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | April 2019 |
| Estimated Primary Completion Date: | April 2016 (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 | |
| Surg Dept, Horsens Regional Hospital | Not yet recruiting |
| Horsens, Region Midt, Denmark, DK-8700 | |
| Contact: Hans Friis-Andersen, MD +4578426222 hans.friis@horsens.rm.dk | |
| Contact: Sanne Harsløf, MD +4578426319 sanne.harslof@horsens.rm.dk | |
Sponsors and Collaborators
Horsens Hospital
Randers Region 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: | March 1, 2012 |
| 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 June 18, 2013