Clinical trial NCT02233569: Comparison of Two Mesh/Fixation Concepts for Laparoscopic Ventral and Incisional Hernia Repair
Official title: COMPARISON OF TWO DIFFERENT CONCEPTS OF MESH AND FIXATION TECHNIQUE IN THE LAPAROSCOPIC OPERATIONS FOR VENTRAL AND INCISIONAL HERNIA - A RANDOMIZED CONTROLLED MONOCENTER TRIAL.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hernia, Abdominal
Hernia,Ventral
Keywords: Laparoscopic hernia repair
Ventral hernia
Incisional hernia
IPOM
Lead sponsor: Polish Hernia Study Group
Sponsor class: OTHER
First posted: 2014-09-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 as a superiority study to proof the concept of previously published mathematical model of front abdominal wall.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Pain
timeFrame: 7 days after the surgery
measure: Pain
timeFrame: 3 months after the surgery
Secondary outcomes:
measure: Number of Participants with Recurrences
timeFrame: up to one year
measure: Number of Participants with complications.
timeFrame: up to one year
measure: Pain intensity
timeFrame: 7 days after the surgery
measure: Pain intensity
timeFrame: 30 days after the surgery
measure: Pain intensity
timeFrame: 3 months after the surgery
measure: Pain intensity
timeFrame: 6 months after the surgery
Other outcomes:
measure: Time of the operation
timeFrame: intraoperative
Locations:
city: Wejherowo
country: Poland
facility: Ceynowa Hospital
state: Pomorskie
Study officials:
name: Maciej Pawlak, MD
role: PRINCIPAL_INVESTIGATOR
name: Maciej Śmietański, PhD
role: STUDY_DIRECTOR
References:
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