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LVHR Multicenter Study

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ClinicalTrials.gov Identifier: NCT00455299
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : October 16, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Ventral and Ventral Insicional Hernia Procedure: Laparoscopic ventral hernia repair Phase 3

Detailed Description:

Patients are randomized to 4 groups: non-absorbable suture fixation and hernia approximation, double crown mesh fixation with titanium spiral tacks with hernia approximation and the same fixations without hernia approximation.

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 156 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Primary Completion Date : October 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: a
a: suture anchoring + tackers and approximation of defect
Procedure: Laparoscopic ventral hernia repair
Active Comparator: b
b: suture anchoring + tackers without approximation of defect
Procedure: Laparoscopic ventral hernia repair
Active Comparator: c
c: only tacker fixation and approximation of defect
Procedure: Laparoscopic ventral hernia repair
Active Comparator: d
d: only tacker fixation without approximation of defect
Procedure: Laparoscopic ventral hernia repair


Outcome Measures

Primary Outcome Measures :
  1. Operating time [ Time Frame: 30-180 min ]
  2. Adhesion score
  3. Mode of entering abdominal cavity
  4. Pain durance [ Time Frame: 8 weeks ]
  5. Seroma formation
  6. Aesthetic result (protrusion) [ Time Frame: 3 years ]
  7. Infection [ Time Frame: 8 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • secondary or primary ventral hernia

Exclusion Criteria:

  • Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00455299


Locations
Norway
SIHF Gjøvik
Gjøvik, Norway
Ullevål University Hospital
Oslo, Norway
Sponsors and Collaborators
Oslo University Hospital
Tyco Healthcare Group
Investigators
Principal Investigator: Jan Lambrecht, MD Oslo University Hospital
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jan Lambrecht, MD, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00455299     History of Changes
Other Study ID Numbers: S-06466b
First Posted: April 3, 2007    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014

Keywords provided by Jan Lambrecht, Oslo University Hospital:
Laparoscopy, ventral, hernia, repair, surgery

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical