Randomized trial comparing self gripping semi-resorbable mesh (PROGRIP) with polypropylene mesh in open inguinal hernioplasty the 6 years result

Abstract

OBJECTIVES: The objective of this randomized controlled trial is to compare the outcomes following self-gripping mesh repair to polypropylene mesh secured with sutures in open inguinal hernioplasty. METHODS: Eligible patients aged 18 to 80 years old, who had primary unilateral uncomplicated inguinal hernia, were randomized into either Polypropylene (PL) group or PROGRIP (PG) group by computer generated code. The primary outcome was the time from mesh placement to end of operation, whereas secondary outcomes included the total operative time, amount of analgesic used, length of post-operative stay, seroma formation, chronic discomfort, chronic pain score and recurrence. The study was registered in www.clinicaltrial.gov carrying ID of NCT00960011. Patients were followed-up in out-patient clinic for 6 years after operation. RESULTS: From March 2009 to April 2016, 45 patients were included. There was no significant difference regarding patient demographics and hernia characteristics. In the PG group, there was significant reduction in time for mesh placement (11.8+/-3.1 min vs. 21.0+/-6.2 min, p<0.001) and total operative time (39.2+/-9.8 min vs. 47.7+/-8.0 min, p=0.003). There was one recurrence in PL group and nil in PG group. Although there was a significant difference in paresthesia between 2 groups, the difference disappears with time and comparable from postoperative 1 year onwards. There was no difference in chronic pain, chronic discomfort demonstrated till 6 years after operation. CONCLUSIONS: Use of PROGRIP mesh in open inguinal hernioplasty effectively reduces the operating time with comparable long-term surgical outcome.