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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
50
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)
Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)
Ceynowa Hospital
Wejherowo, Pomeranian Voivodeship, Poland
Pain
Presence of pain 7 days after the surgery.
Time frame: 7 days after the surgery
Pain
Presence of pain 3 months after the surgery.
Time frame: 3 months after the surgery
Number of Participants with Recurrences
The recurrence rate in one year followup.
Time frame: up to one year
Number of Participants with complications.
The description and percentage distribution of short and long term complications following surgery.
Time frame: up to one year
Pain intensity
Intensity of pain measured on a visual analogue scale 7 days after the surgery
Time frame: 7 days after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 30 days after the surgery
Time frame: 30 days after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 3 months after the surgery.
Time frame: 3 months after the surgery
Pain intensity
Intensity of pain measured on a visual analogue scale 6 months after the surgery.
Time frame: 6 months after the surgery
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