Laparoscopic resorbable mesh fixation. Assessment of an innovative disposable instrument delivering resorbable fixation devices: I-Clip(TM). Final results of a prospective multicentre clinical trial

Abstract

Background: The aim of this study was to assess the performance and tolerance of an innovative disposable instrument delivering resorbable clips (I-Clip, Sofradim, France) intended for mesh fixation in inguinal, incisional and umbilical hernias of the abdominal wall. The fixation device was designed to be resorbable in 1 year, with reduced trauma to the underlying tissues or the mesh, and with initial mechanical properties equivalent to those of conventional metal staples.

Methods: The study involved 105 patients with inguinal, umbilical or incisional hernias enrolled from 11 centres. Inguinal totally extra peritoneal (TEP) or trans abdomino pre-peritoneal (TAPP) repair was performed with Parietex mesh, incisional or umbilical hernias were treated via the intraperitoneal route with Parietex composite. I-Clips were used for mesh fixation in both indications according to the surgeon's habits. Efficacy was the principal assessment criteria evaluated by two parameters: quality of fixation evaluated subjectively at the time of procedure and recurrence rate according to the follow up at 1, 6 and 12 months. Pain evaluated by the patients using a visual analogue scale (VAS) was the principal secondary assessment criteria. Other tolerance criteria were also evaluated during surgery and follow up.

Results: The surgeons' evaluation of the fixation quality was assessed as good to very good in 100% of ventral hernias and good to very good in 85-92% of inguinal hernias. At 1 month, 90% of patients (94/104) were totally pain-free (VAS score: 0) and only ten patients reported low pain (VAS scores: 0.3-3.1). At 1 year, the pain described by those ten patients finally disappeared, 98% of patients (102/104) were totally pain-free. The rate of minor complications not related to the device concerned 5% of the patients at 1 month, which was reduced to 2% at one year and no recurrence or mesh sepsis was observed.

Conclusions: The ease of use of this device, combined with the absence of recurrence related to the investigated device and the good pain-free outcome in this group of patients confirmed the effectiveness and tolerance of the resorbable fixation concept of I-Clip(TM).