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3 Fixation Devices in Laparoscopic Ventral Herniotomy (FS)

Primary Purpose

Ventral Hernia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
laparoscopic ventral herniotomy
Protack
Securestrap
Glubran
Sponsored by
Horsens Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventral Hernia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Hospital Horsens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

fixation with Protack

fixation with Securestrap

fixation with Glubran

Arm Description

surgery

Outcomes

Primary Outcome Measures

Pain
Dolo Test (VAS)

Secondary Outcome Measures

hernia recurrence
clinical examination and perhaps CT scan
quality of life
SF 36 and Carolina's Comfort Scale
Pain
Dolo Test(VAS)

Full Information

First Posted
February 9, 2012
Last Updated
February 18, 2020
Sponsor
Horsens Hospital
Collaborators
Randers Regional Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01534780
Brief Title
3 Fixation Devices in Laparoscopic Ventral Herniotomy
Acronym
FS
Official Title
A Controlled Randomized Study of Protack, Securestrap and Glubran Glue as Fixation Devices in Laparoscopic Ventral Herniotomy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Horsens Hospital
Collaborators
Randers Regional Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventral Hernia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fixation with Protack
Arm Type
Experimental
Arm Title
fixation with Securestrap
Arm Type
Experimental
Arm Title
fixation with Glubran
Arm Type
Experimental
Arm Description
surgery
Intervention Type
Procedure
Intervention Name(s)
laparoscopic ventral herniotomy
Other Intervention Name(s)
no other names
Intervention Description
Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
Intervention Type
Device
Intervention Name(s)
Protack
Intervention Description
fixation of mesh with protack
Intervention Type
Device
Intervention Name(s)
Securestrap
Intervention Description
fixation of mesh with Securestrap
Intervention Type
Device
Intervention Name(s)
Glubran
Intervention Description
fixation of mesh with Glubran
Primary Outcome Measure Information:
Title
Pain
Description
Dolo Test (VAS)
Time Frame
1 measurement, 2nd postoperative day
Secondary Outcome Measure Information:
Title
hernia recurrence
Description
clinical examination and perhaps CT scan
Time Frame
7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Title
quality of life
Description
SF 36 and Carolina's Comfort Scale
Time Frame
7 measurements, postoperative month 1, 6, 12, 24, 36, 48 and 60
Title
Pain
Description
Dolo Test(VAS)
Time Frame
7 measurements, day 1, 3 and 4 and postoperative month 1, 6, 12, 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanne S Harsløf, MD
Organizational Affiliation
Horsens Regional Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thorbjørn Sommer, MD, PhD
Organizational Affiliation
Randers Regional Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Regional Hospital Horsens
City
Horsens
ZIP/Postal Code
8700
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
29799075
Citation
Harslof S, Krum-Moller P, Sommer T, Zinther N, Wara P, Friis-Andersen H. Effect of fixation devices on postoperative pain after laparoscopic ventral hernia repair: a randomized clinical trial of permanent tacks, absorbable tacks, and synthetic glue. Langenbecks Arch Surg. 2018 Jun;403(4):529-537. doi: 10.1007/s00423-018-1676-z. Epub 2018 May 25.
Results Reference
derived

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3 Fixation Devices in Laparoscopic Ventral Herniotomy

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