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).
Lepere
M
M
Clinique St. Charles, 11 bd René Levesque, BP 669, 85016 La Roche sur Yon Cedex, France. lepere.marc@wanadoo.fr
Benchetrit
S
S
Bertrand
J C
JC
Chalbet
J Y
JY
Combier
J P
JP
Detruit
B
B
Herbault
G
G
Jarsaillon
P
P
Lagoutte
J
J
Levard
H
H
Rignier
P
P
D004209:Disposable Equipment; D005260:Female; D006552:Hernia, Inguinal / Q000601:surgery*; D006554:Hernia, Umbilical / Q000601:surgery*; D006801:Humans; D010535:Laparoscopy / Q000379:methods*; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D011183:Postoperative Complications; D011446:Prospective Studies; D013525:Surgical Instruments; D013526:Surgical Mesh; D016896:Treatment Outcome