LVHR Multicenter Study

Ventral and Ventral Insicional Hernia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00455299
• Other study ID #: S-06466b
• Status: Completed
• Phase: Phase 3
• First received: April 2, 2007
• Last updated: October 14, 2014
• Start date: March 2007
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: The Data InspectorateNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Ventral and Ventral Insicional Hernia

Intervention

Procedure:
• Laparoscopic ventral hernia repair

Locations

Country	Name	City	State
Norway	SIHF Gjøvik	Gjøvik
Norway	Ullevål University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Oslo University Hospital	Tyco Healthcare Group

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Operating time		30-180 min	No
Primary	Adhesion score			No
Primary	Mode of entering abdominal cavity			No
Primary	Pain durance		8 weeks	No
Primary	Seroma formation			No
Primary	Aesthetic result (protrusion)		3 years	No
Primary	Infection		8 weeks	Yes