3 Fixation Devices in Laparoscopic Ventral Herniotomy

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
see brief summary

Official Title
-----------------
A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Procedure: laparoscopic ventral herniotomy
* Device: Protack
* Device: Securestrap
* Device: Glubran


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fixation with Protack<br> | Procedure: laparoscopic ventral herniotomy<br>* Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices<br>* Other names: no other names;Device: Protack<br>* fixation of mesh with protack<br>|
| Experimental: fixation with Securestrap<br> | Procedure: laparoscopic ventral herniotomy<br>* Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices<br>* Other names: no other names;Device: Securestrap<br>* fixation of mesh with Securestrap<br>|
| Experimental: fixation with Glubran<br>surgery | Procedure: laparoscopic ventral herniotomy<br>* Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices<br>* Other names: no other names;Device: Glubran<br>* fixation of mesh with Glubran<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | Dolo Test (VAS) | 1 measurement, 2nd postoperative day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hernia recurrence | clinical examination and perhaps CT scan | 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 | 
| quality of life | SF 36 and Carolina's Comfort Scale | 7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60 | 
| Pain | Dolo Test(VAS) | 7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24 |