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LVHR Multicenter Study

This study has been completed.
Tyco Healthcare Group
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital Identifier:
First received: April 2, 2007
Last updated: October 14, 2014
Last verified: October 2014
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 Intervention Phase
Ventral and Ventral Insicional Hernia
Procedure: Laparoscopic ventral hernia repair
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Jan Lambrecht, Oslo University Hospital:

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

Enrollment: 156
Study Start Date: March 2007
Study Completion Date: December 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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Please refer to this study by its identifier: NCT00455299

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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jan Lambrecht, MD, Oslo University Hospital Identifier: NCT00455299     History of Changes
Other Study ID Numbers: S-06466b
Study First Received: April 2, 2007
Last Updated: October 14, 2014

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

Additional relevant MeSH terms:
Pathological Conditions, Anatomical processed this record on May 25, 2017