LVHR Multicenter Study
Randomized Controlled National Multicenter Study for Evaluation of Two Different Ways of Fixation of Mesh-implants and Differences With or Without Approximation of Herniadefects at Laparoscopic Operation for Incisional and Ventral Hernia
1 other identifier
interventional
156
1 country
2
Brief Summary
The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2007
Longer than P75 for phase_3
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
April 2, 2007
CompletedFirst Posted
Study publicly available on registry
April 3, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 16, 2014
October 1, 2014
6.6 years
April 2, 2007
October 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
Operating time
30-180 min
Adhesion score
Mode of entering abdominal cavity
Pain durance
8 weeks
Seroma formation
Aesthetic result (protrusion)
3 years
Infection
8 weeks
Study Arms (4)
a
ACTIVE COMPARATORa: suture anchoring + tackers and approximation of defect
b
ACTIVE COMPARATORb: suture anchoring + tackers without approximation of defect
c
ACTIVE COMPARATORc: only tacker fixation and approximation of defect
d
ACTIVE COMPARATORd: only tacker fixation without approximation of defect
Interventions
Eligibility Criteria
You may qualify if:
- secondary or primary ventral hernia
You may not qualify if:
- Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oslo University Hospitallead
- Tyco Healthcare Groupcollaborator
Study Sites (2)
SIHF Gjøvik
Gjøvik, Norway
Ullevål University Hospital
Oslo, Norway
Related Publications (2)
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.
PMID: 25663605DERIVEDLambrecht 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.
PMID: 24684675DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jan Lambrecht, MD
Oslo University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
April 2, 2007
First Posted
April 3, 2007
Study Start
March 1, 2007
Primary Completion
October 1, 2013
Study Completion
December 1, 2013
Last Updated
October 16, 2014
Record last verified: 2014-10