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LVHR Multicenter Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00455299
Recruitment Status : Completed
First Posted : April 3, 2007
Last Update Posted : October 16, 2014
Tyco Healthcare Group
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital

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.

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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
Actual Primary Completion Date : October 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

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

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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • secondary or primary ventral hernia

Exclusion Criteria:

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

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 identifier (NCT number): NCT00455299

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Jan Lambrecht, MD, Oslo University Hospital Identifier: NCT00455299    
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:
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Pathological Conditions, Anatomical