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
PHASE3
156 participants
INTERVENTIONAL
2007-03-31
2013-12-31
Brief Summary
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Detailed Description
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Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic result (protrusion), organ traumatization infection. Endpoints are correlated to hernia size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3 years after operation with clinical examination.
300 patients are planned included in primary study. A subgroup of organ transplanted patients is evaluated in a separate study with identical criteria for inclusion.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
NONE
Study Groups
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a
a: suture anchoring + tackers and approximation of defect
Laparoscopic ventral hernia repair
b
b: suture anchoring + tackers without approximation of defect
Laparoscopic ventral hernia repair
c
c: only tacker fixation and approximation of defect
Laparoscopic ventral hernia repair
d
d: only tacker fixation without approximation of defect
Laparoscopic ventral hernia repair
Interventions
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Laparoscopic ventral hernia repair
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Tyco Healthcare Group
INDUSTRY
Oslo University Hospital
OTHER
Responsible Party
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Jan Lambrecht
MD
Principal Investigators
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Jan Lambrecht, MD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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SIHF Gjøvik
Gjøvik, , Norway
Ullevål University Hospital
Oslo, , Norway
Countries
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References
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Lambrecht JR, Vaktskjold A, Trondsen E, Oyen OM, Reiertsen O. Laparoscopic ventral hernia repair: outcomes in primary versus incisional hernias: no effect of defect closure. Hernia. 2015 Jun;19(3):479-86. doi: 10.1007/s10029-015-1345-x. Epub 2015 Feb 7.
Lambrecht JR, Skauby M, Trondsen E, Vaktskjold A, Oyen OM. Laparoscopic repair of incisional hernia in solid organ-transplanted patients: the method of choice? Transpl Int. 2014 Jul;27(7):712-20. doi: 10.1111/tri.12327. Epub 2014 May 9.
Other Identifiers
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S-06466b
Identifier Type: -
Identifier Source: org_study_id
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