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.

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).

[The repair of extensive evisceration using an absorbable prosthesis]. / Vuzstanoviavane na obshirni evistseratsii s pomoshtta na absorbirashta se proteza.

The use of an absorbable material in the form of a permeable mesh of polyglactin 910 is proposed for the treatment of extensive evisceration regardless of etiology. Its strength and excellent tolerance by the body even in the presence of infection justify its intraperitoneal placement on the deep surface of the peritoneum, in contact with the viscera and in reconstruction of the parietal wall. Perfect retention of the viscera in place is assured and the reconstructed parietal wall seems solid and stable, the absorbable mesh being rapidly replaced by host connective tissue of good quality. This technique, applicable to all cases of evisceration, is valuable in the surgical treatment of such patients, which is frequently difficult at best.

[Reflection on the use of the polyglactine 910 self resorbing mesh in the treatment of hernias and ventral ruptures (author's transl)]. / Réflexion sur l'utilisation du treillis résorbable de polyglactine 910 dans le traitement des hernies et des éventrations.

The long term results obtained by Polyglactine 910 mesh in the treatment of eviscerations has lead us to specify its conditions of use in the surgical treatment of wall ruptures. As it is self resorbing, it may not be used on its own. But its remarkable acceptance allowing it to be fitted in an intra-peritoneal position, with very lateral stitches, makes it a most outstanding material for top quality assisted sutures.