BACKGROUND: This study presents intermediate follow-up data on a randomized prospective series of patients undergoing either amodified laparoscopic intraperitoneal onlay mesh herniorrhaphy (IPOM) or conventional anterior inguinal herniorrhaphy (CH). METHODS:All patients from two university affiliated hospitals with primary or recurrent inguinal hernias were recruited for randomization to either the IPOM technique utilizing a meshed expanded polytetrafluorethylene (ePTFE) soft tissue patch or CH. Follow-up data were gathered from postoperative clinic visits and telephone and mail surveys. RESULTS: Previously reported early recurrence and complication rates at a mean follow-up of 8 months were 1 of 30 (3%) and 5 of 30 (17%) for IPOM, and 2 of 28 (7%) and 5 of 28 (18%) for CH. Intermediate follow-up with 50 (23 IPOM and 27 CH) of the original 58 patients (86%) at a mean of 41 months reveals a recurrence rate of 10 of 23 (43%) for the IPOM group and 4 of 27 (15%) for the CH group (P = 0.053). Five delayed complications occurred in 4 IPOM patients (port site hernia 4, painful neuroma 1), while 2 delayed complications (unilateral testicular atrophy 2) occurred in 2 patients in the CH group. One IPOM versus 5 CH patients subsequently developed previously unrecognized contralateral hernias. There was 1 death unrelated to previous herniorrhaphy in each group. CONCLUSIONS:IPOM recurrence rates (43%) at a mean follow-up of 41 months are excessively high when compared with CH (15%) or with preliminary results of IPOM at 8 months of follow-up (3%). Despite reduced perioperative pain and disability and promising preliminary results in the IPOM group, these intermediate follow-up data strongly suggest that the IPOM technique should not be used for repair of inguinal hernias.
RCT Entities:
BACKGROUND: This study presents intermediate follow-up data on a randomized prospective series of patients undergoing either a modified laparoscopic intraperitoneal onlay mesh herniorrhaphy (IPOM) or conventional anterior inguinal herniorrhaphy (CH). METHODS: All patients from two university affiliated hospitals with primary or recurrent inguinal hernias were recruited for randomization to either the IPOM technique utilizing a meshed expanded polytetrafluorethylene (ePTFE) soft tissue patch or CH. Follow-up data were gathered from postoperative clinic visits and telephone and mail surveys. RESULTS: Previously reported early recurrence and complication rates at a mean follow-up of 8 months were 1 of 30 (3%) and 5 of 30 (17%) for IPOM, and 2 of 28 (7%) and 5 of 28 (18%) for CH. Intermediate follow-up with 50 (23 IPOM and 27 CH) of the original 58 patients (86%) at a mean of 41 months reveals a recurrence rate of 10 of 23 (43%) for the IPOM group and 4 of 27 (15%) for the CH group (P = 0.053). Five delayed complications occurred in 4 IPOMpatients (port site hernia 4, painful neuroma 1), while 2 delayed complications (unilateral testicular atrophy 2) occurred in 2 patients in the CH group. One IPOM versus 5 CH patients subsequently developed previously unrecognized contralateral hernias. There was 1 death unrelated to previous herniorrhaphy in each group. CONCLUSIONS:IPOM recurrence rates (43%) at a mean follow-up of 41 months are excessively high when compared with CH (15%) or with preliminary results of IPOM at 8 months of follow-up (3%). Despite reduced perioperative pain and disability and promising preliminary results in the IPOM group, these intermediate follow-up data strongly suggest that the IPOM technique should not be used for repair of inguinal hernias.