Glue vs. Tacks in Mesh Fixation for Minimally Invasive Inguinal Hernia Repair – A Randomised Controlled Trial

Brief name: mesh fixation methods in laparoscopic totally extra-peritoneal (TEP) inguinal hernia repair (IHR) Why: there is controversy surrounding the ideal fixation method for mesh in laparoscopic hernia repair. The goal of this study was to compare different mesh fixation methods in TEP IHR with the primary outcome focusing on chronic post-operative inguinal pain, which is a known complication of IHR. Arm 1: Absorbable tack fixation *tacks made of an absorbable synthetic polyester copolymer. Intra-operatively, they are applied using a laparoscopic absorbable tack fixation device. Manufactured by Medtronic (NSW, Australia). Arm 2: Cyanoacrylate glue fixation * Glubran2 is a cyanoacrylate glue that is modified by the addition of a monomer synthesized by the manufacturer. Intra-operatively, it is applied using a laparoscopic glue application tool. Manufactured by Matrix Surgical (Clayton, VIC, Australia). Procedures: each intervention arm involved patients aged 18 years or over, undergoing elective laparoscopic TEP IHR. Apart from mesh fixation, all other aspects of surgery and aftercare remained the same in both arm. Who: eligible care providers were all General Surgeons who were fellows of the Royal Australasian College of Surgeons (RACS). How: mesh fixation was performed intra-operatively on each patient enrolled in the study. It was performed by participating surgeons as described above. Where: The interventions occurred at two centres, The Northern and Broadmeadows Hospitals. The Northern Hospital is a 400-bed tertiary health centre situated in Epping, Melbourne, Victoria, Australia. Broadmeadows Hospital is a smaller surgical health centre, located in Broadmeadows, Melbourne, Victoria, Australia. Both centres are part of the Northern Health Service, and provide tertiary health care to the metropolitan and rural communities of north-western Victoria. When and How Much: Each intervention was performed once per hernia. In the case of patients who had bilateral hernia repairs in the same operation, each individual hernia was randomised separately to receive an intervention. The intervention occurred during the patient's operation, with no further interventions after the hernia repair. Tailoring: interventions (mesh fixation methods) were not personalised, titrated or adapted to participants. Modifications: interventions (mesh fixation methods) were not modified during the course of the study How Well Planned/Actual: surgeon adherence to the correct method of cyanoacrylate glue mesh fixation was enhanced by the presence of the manufacturer’s representative during the operation. This did not occur during absorbable tack mesh fixation as it was considered the "standard-of-care" method.