INTRODUCTION: Mesh plug is an established and effective method for repair of inguinal hernia. The ProLoop plug (Atrium) is a recently developed mesh plug with a novel configuration, which may offer advantages over the standard Prefix plug (Bard) or the Lichtenstein repair. This two-centre double-blinded randomised control trial assessed the short- and medium-term outcomes, comparing the above three methods. PATIENTS AND METHODS: Consecutive patients over the age of 18 years with primary unilateral inguinal hernia were randomised to receive a Lichtenstein tension free mesh repair (LTFM), Perfix plug (Bard) (PF) or ProLoop plug (Atrium) (PL) repair. Follow-up was at 2 weeks, 6 months and 12 months. Endpoints were operative time, hospital stay, bodily pain scores, return to daily activity and complications. RESULTS: A total of 295 consecutive patients were recruited to the study. Ninety-three patients were randomised to receive PL plug repairs, 101 PF plug repairs and 101 LTFM repairs. There was no significant difference among the three groups in terms of age, sex or BMI. There was no significant difference among the groups in terms of operative time (PL vs PF P = 0.92; PL vs LTFM P = 0.52), hospital stay (PL vs PF P = 0.74; PL vs LTFM P = 0.44), bodily pain scores (at 12 months PL vs PF P = 0.84, PL vs LTFM P = 0.85, PF vs LTFM P = 0.16), complication rates or return to daily activity. CONCLUSIONS: The ProLoop plug (Atrium) is a safe and effective method of repairing primary inguinal hernias. Its novel lightweight configuration does not increase the risk of recurrence when compared to thicker mesh plugs, and it may offer benefit in terms of long-term patient comfort. The ProLoop plug (Atrium) represents a new effective alternative to the established mesh repairs.
RCT Entities:
INTRODUCTION: Mesh plug is an established and effective method for repair of inguinal hernia. The ProLoop plug (Atrium) is a recently developed mesh plug with a novel configuration, which may offer advantages over the standard Prefix plug (Bard) or the Lichtenstein repair. This two-centre double-blinded randomised control trial assessed the short- and medium-term outcomes, comparing the above three methods. PATIENTS AND METHODS: Consecutive patients over the age of 18 years with primary unilateral inguinal hernia were randomised to receive a Lichtenstein tension free mesh repair (LTFM), Perfix plug (Bard) (PF) or ProLoop plug (Atrium) (PL) repair. Follow-up was at 2 weeks, 6 months and 12 months. Endpoints were operative time, hospital stay, bodily pain scores, return to daily activity and complications. RESULTS: A total of 295 consecutive patients were recruited to the study. Ninety-three patients were randomised to receive PL plug repairs, 101 PF plug repairs and 101 LTFM repairs. There was no significant difference among the three groups in terms of age, sex or BMI. There was no significant difference among the groups in terms of operative time (PL vs PF P = 0.92; PL vs LTFM P = 0.52), hospital stay (PL vs PF P = 0.74; PL vs LTFM P = 0.44), bodily pain scores (at 12 months PL vs PF P = 0.84, PL vs LTFM P = 0.85, PF vs LTFM P = 0.16), complication rates or return to daily activity. CONCLUSIONS: The ProLoop plug (Atrium) is a safe and effective method of repairing primary inguinal hernias. Its novel lightweight configuration does not increase the risk of recurrence when compared to thicker mesh plugs, and it may offer benefit in terms of long-term patient comfort. The ProLoop plug (Atrium) represents a new effective alternative to the established mesh repairs.
Authors: Leigh Neumayer; Anita Giobbie-Hurder; Olga Jonasson; Robert Fitzgibbons; Dorothy Dunlop; James Gibbs; Domenic Reda; William Henderson Journal: N Engl J Med Date: 2004-04-25 Impact factor: 91.245