LVHR Multicenter Study

University of Oslo (UIO)

Status and phase: Completed; Phase 3

Conditions: Ventral and Ventral Insicional Hernia

Treatments: Procedure: Laparoscopic ventral hernia repair

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00455299

S-06466b

Details and patient eligibility

About

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.

Full 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.

Enrollment: 156 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• secondary or primary ventral hernia

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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156 participants in 4 patient groups

a

Active Comparator group

Description:

a: suture anchoring + tackers and approximation of defect

Treatment:

Procedure: Laparoscopic ventral hernia repair

b

Active Comparator group

Description:

b: suture anchoring + tackers without approximation of defect

Treatment:

Procedure: Laparoscopic ventral hernia repair

c

Active Comparator group

Description:

c: only tacker fixation and approximation of defect

Treatment:

Procedure: Laparoscopic ventral hernia repair

d

Active Comparator group

Description:

d: only tacker fixation without approximation of defect

Treatment:

Procedure: Laparoscopic ventral hernia repair