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

Objectives: The use of absorbable polylactic acid hook self-gripping polypropylene mesh in open inguinal hernia may potentially reduce operative time and enhance patient recovery. The objective of this randomized trial is to compare the outcomes following self-gripping mesh repair to polypropylene mesh secured with sutures in open inguinal hernioplasty.

Method: Eligible patients aged 18-80 years old, who had primary unilateral uncomplicated inguinal hernia, were randomized into either Polypropylene (PL) group or PROGRIP (PG) group just before the placement of mesh intra-operatively 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 has been registered in http://www.clinicaltrial.gov carrying an ID of NCT00960011. Patients were followed-up in outpatient clinic for up to 6 years after operation.

Results: From March 2009 to April 2016, 45 patients were included. The mean age of PG group (n = 22) was 62.0 ± 15.7 years old while that of the PL group was 62.6 ± 4.9 years old (n = 23). There was no significant difference regarding the smoking habit, drinking habit, comorbidities, previous hernia operation and Nyhus type of hernia between the two groups. The size of defects, the time of groin dissection and the size of incision were similar. In the PG group, there was significant reduction in the time for mesh placement (11.8 ± 3.1 vs. 21.0 ± 6.2 min, p < 0.001) and total operative time (39.2 ± 9.8 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 after operation, the difference disappears with time and comparable from post-operative 1 year onwards. There was no difference in chronic pain, chronic discomfort, affect daily activities, palpable mesh demonstrated throughout the whole study period till 6 years after operation.

Conclusions: The use of polylactic acid self-gripping mesh in open inguinal hernia repair effectively reduces the operating time with comparable long-term surgical outcome with traditional polypropylene mesh.