LVHR Multicenter Study

Phase 3

Completed

• Conditions: Ventral and Ventral Insicional Hernia
• Interventions: Procedure: Laparoscopic ventral hernia repair

• Registration Number: NCT00455299
• Lead Sponsor: Oslo University Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-04-02
• Study First Submitted QC: 2007-04-02
• Study First Posted: 2007-04-03
• Primary Completion: 2013-10
• Study Completion: 2013-12
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-14
• Last Update Posted: 2014-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

Inclusion Criteria

• secondary or primary ventral hernia

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
d	Laparoscopic ventral hernia repair	d: only tacker fixation without approximation of defect
c	Laparoscopic ventral hernia repair	c: only tacker fixation and approximation of defect
b	Laparoscopic ventral hernia repair	b: suture anchoring + tackers without approximation of defect
a	Laparoscopic ventral hernia repair	a: suture anchoring + tackers and approximation of defect

Primary Outcome Measures

Name	Time	Method
Mode of entering abdominal cavity
Operating time	30-180 min
Pain durance	8 weeks
Infection	8 weeks
Adhesion score
Seroma formation
Aesthetic result (protrusion)	3 years

Trial Locations

Locations (2)

Ullevål University Hospital; 🇳🇴 Oslo, Norway

SIHF Gjøvik; 🇳🇴 Gjøvik, Norway