Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

LVHR Multicenter Study

This study has been completed.
Sponsor:
Collaborator:
Tyco Healthcare Group
Information provided by (Responsible Party):
Jan Lambrecht, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00455299
First received: April 2, 2007
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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
Endpoint Classification: Efficacy Study
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 Oslo University Hospital:

Primary Outcome Measures:
  • Operating time [ Time Frame: 30-180 min ] [ Designated as safety issue: No ]
  • Adhesion score [ Designated as safety issue: No ]
  • Mode of entering abdominal cavity [ Designated as safety issue: No ]
  • Pain durance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Seroma formation [ Designated as safety issue: No ]
  • Aesthetic result (protrusion) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Infection [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Oslo University Hospital

Additional 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
Study First Received: April 2, 2007
Last Updated: October 14, 2014
Health Authority: Norway: The Data Inspectorate
Norway: Directorate of Health

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

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on November 24, 2014