Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
75 participants
INTERVENTIONAL
2013-04-30
2017-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
TRIPLE
Study Groups
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fixation with Protack
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
Protack
fixation of mesh with protack
fixation with Securestrap
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
Securestrap
fixation of mesh with Securestrap
fixation with Glubran
surgery
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
Glubran
fixation of mesh with Glubran
Interventions
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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
Protack
fixation of mesh with protack
Securestrap
fixation of mesh with Securestrap
Glubran
fixation of mesh with Glubran
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* danish speaking
* of sound mind
* bmi \< 35
* ASA 3 or less, no contra indication against laparoscopy
Exclusion Criteria
* no danish,
* bmi \> 35
18 Years
75 Years
ALL
No
Sponsors
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Randers Regional Hospital
OTHER
Horsens Hospital
OTHER
Responsible Party
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Hans Friis-Andersen
Principal Investigator
Principal Investigators
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Sanne S Harsløf, MD
Role: STUDY_CHAIR
Regionshospitalet Horsens
Thorbjørn Sommer, MD, PhD
Role: STUDY_DIRECTOR
Randers Regional Hospital
Locations
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Regional Hospital Horsens
Horsens, , Denmark
Countries
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References
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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.
Other Identifiers
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KIR-001-HRH
Identifier Type: -
Identifier Source: org_study_id
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