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Completed

NCT Number: NCT00455299

LVHR Multicenter Study

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.

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Key information

Conditions

Ventral and Ventral Insicional Hernia Hernia Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SIHF Gjøvik, Gjøvik, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • secondary or primary ventral hernia

Exclusion criteria

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

Treatment and study plan

Laparoscopic ventral hernia repair

Procedure

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

  • Tyco Healthcare Group

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Apr 3, 2007
Registry last updated
Oct 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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