Status:
TERMINATED
Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
Lead Sponsor:
Polish Hernia Study Group
Conditions:
Hernia, Abdominal
Hernia,Ventral
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This is a monocenter randomized controlled trial comparing two systems of mesh and fixation device for the laparoscopic ventral and incisional hernia repair with respect to pain. It has been designed ...
Eligibility Criteria
Inclusion
- Informed Consent Form (ICF) signed by the patient or his/her legal representative
- primary or secondary ventral hernia less than 20 cm in length and less than 11 cm in width requiring elective surgical repair
- recurrence after former abdominal hernia repair WITH MESH
- recurrence after suture abdominal hernia repair CAN be included
Exclusion
- no written informed consent
- patient under 18 years old
- emergency surgery (incarcerated hernia)
- patients with expected life time shorter than one year for example due to generalised malignancy
- BMI exceeding 40.0kg/m²
- contaminated surgical fields
- patients on immunosuppression, steroid therapy, constant pain therapy
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02233569
Start Date
November 1 2012
End Date
February 1 2014
Last Update
September 8 2014
Active Locations (1)
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1
Ceynowa Hospital
Wejherowo, Pomeranian Voivodeship, Poland, 84-200