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LVHR Multicenter Study

Primary Purpose

Ventral and Ventral Insicional Hernia

Status

Completed

Phase

Phase 3

Locations

Norway

Study Type

Interventional

Intervention

Laparoscopic ventral hernia repair

About this trial

This is an interventional treatment trial for Ventral and Ventral Insicional Hernia focused on measuring Laparoscopy, ventral, hernia, repair, surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

SIHF Gjøvik
Ullevål University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Arm Label

Arm Description

a: suture anchoring + tackers and approximation of defect

b: suture anchoring + tackers without approximation of defect

c: only tacker fixation and approximation of defect

d: only tacker fixation without approximation of defect

Outcomes

Primary Outcome Measures

Operating time

Adhesion score

Mode of entering abdominal cavity

Pain durance

Seroma formation

Aesthetic result (protrusion)

Infection

Secondary Outcome Measures

Full Information

NCT ID

NCT00455299

First Posted

April 2, 2007

Last Updated

October 14, 2014

Sponsor

Oslo University Hospital

Collaborators

Tyco Healthcare Group

1. Study Identification

Unique Protocol Identification Number

NCT00455299

Brief Title

LVHR Multicenter Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

October 2013 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Oslo University Hospital

Collaborators

Tyco Healthcare Group

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ventral and Ventral Insicional Hernia

Keywords

Laparoscopy, ventral, hernia, repair, surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

a: suture anchoring + tackers and approximation of defect

Arm Title

Arm Type

Active Comparator

Arm Description

b: suture anchoring + tackers without approximation of defect

Arm Title

Arm Type

Active Comparator

Arm Description

c: only tacker fixation and approximation of defect

Arm Title

Arm Type

Active Comparator

Arm Description

d: only tacker fixation without approximation of defect

Intervention Type

Procedure

Intervention Name(s)

Laparoscopic ventral hernia repair

Primary Outcome Measure Information:

Title

Operating time

Time Frame

30-180 min

Title

Adhesion score

Title

Mode of entering abdominal cavity

Title

Pain durance

Time Frame

8 weeks

Title

Seroma formation

Title

Aesthetic result (protrusion)

Time Frame

3 years

Title

Infection

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: secondary or primary ventral hernia Exclusion Criteria: Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Lambrecht, MD

Organizational Affiliation

Oslo University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

SIHF Gjøvik

City

Gjøvik

Country

Norway

Facility Name

Ullevål University Hospital

City

Oslo

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

25663605

Citation

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.

Results Reference

derived

PubMed Identifier

24684675

Citation

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.

Results Reference

derived

Learn more about this trial

LVHR Multicenter Study

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