A randomized controlled trial comparing short-term outcomes of self-gripping (Progrip) mesh versus fibrin sealant in laparoscopic total extraperitoneal hernioplasty

Abstract

Background: There are no data comparing the use of self-gripping mesh with standard mesh in total extraperitoneal repair (TEP). In this prospective study we aim to study the incidence of chronic pain between Progrip (PG) and standard mesh fixed by fibrin sealant (FS).

Materials and Methods: Under Institutional Review Board approval, from April 2016 to May 2017, patients with primary unilateral or bilateral inguinal hernia eligible for TEP were recruited. Before mesh insertion they were randomized into PG or FS (Tisseel). Demographics, intraoperative, and postoperative data were recorded. Patients were followed up for at least 1 year. Visual Analog Scale was used to record pain scores. Primary outcome was the incidence of chronic pain at 3 months after surgery.

Results: One hundred fifty patients were randomized. Of the 150 patients (193 hernias), 76 were randomized to PG and 74 randomized to FS. Demographic data such as age, presence of comorbidities, smoking history, mean body mass index was comparable in both groups. Bilateral hernias occurred in 25 (32.9%) and 18 (24.3%) patients in PG and FS group, respectively. Mean mesh deployment time was 283.7 seconds (range, 140 to 720 s) in PG group and 301.9 seconds (range, 67 to 1006 s) in FS group (P=0.30). A total of 5 patients were lost at follow-up and they were excluded from subsequent data analysis. Seroma occurred in 15 (20.3%) and 16 (22.5%) patients in PG and FS group, respectively (P=0.45). Mean Visual Analog Scale at 2 weeks (cough) was highest at 1.05 and 1.02 in PG and FS group, respectively (P=0.62). Eight (12.3%) and 15 (23.4%) patients in PG and FG group, respectively, reported pain at 3-month follow-up (P=0.1). Of those who experienced pain, majority was mild pain which did not affect activities of daily living. At a mean follow-up of 13.1±5.4 months, no recurrence was detected.

Conclusions: There was no significant difference in terms of chronic pain between PG and FS group. The use of PG is effective in TEP.