LVHR Multicenter Study

NCT ID: NCT00455299

Last Updated: 2014-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ventral and Ventral Insicional Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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a

a: suture anchoring + tackers and approximation of defect

Group Type ACTIVE_COMPARATOR

Laparoscopic ventral hernia repair

Intervention Type PROCEDURE

b

b: suture anchoring + tackers without approximation of defect

Group Type ACTIVE_COMPARATOR

Laparoscopic ventral hernia repair

Intervention Type PROCEDURE

c

c: only tacker fixation and approximation of defect

Group Type ACTIVE_COMPARATOR

Laparoscopic ventral hernia repair

Intervention Type PROCEDURE

d

d: only tacker fixation without approximation of defect

Group Type ACTIVE_COMPARATOR

Laparoscopic ventral hernia repair

Intervention Type PROCEDURE

Interventions

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Laparoscopic ventral hernia repair

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* secondary or primary ventral hernia

Exclusion Criteria

* Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tyco Healthcare Group

INDUSTRY

Sponsor Role collaborator

Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jan Lambrecht

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan Lambrecht, MD

Role: PRINCIPAL_INVESTIGATOR

Oslo University Hospital

Locations

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SIHF Gjøvik

Gjøvik, , Norway

Site Status

Ullevål University Hospital

Oslo, , Norway

Site Status

Countries

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Norway

References

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Lambrecht JR, Vaktskjold A, Trondsen E, Oyen OM, Reiertsen O. Laparoscopic ventral hernia repair: outcomes in primary versus incisional hernias: no effect of defect closure. Hernia. 2015 Jun;19(3):479-86. doi: 10.1007/s10029-015-1345-x. Epub 2015 Feb 7.

Reference Type DERIVED
PMID: 25663605 (View on PubMed)

Lambrecht JR, Skauby M, Trondsen E, Vaktskjold A, Oyen OM. Laparoscopic repair of incisional hernia in solid organ-transplanted patients: the method of choice? Transpl Int. 2014 Jul;27(7):712-20. doi: 10.1111/tri.12327. Epub 2014 May 9.

Reference Type DERIVED
PMID: 24684675 (View on PubMed)

Other Identifiers

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S-06466b

Identifier Type: -

Identifier Source: org_study_id

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