Tep Inguinal Hernia Repair Compared With Lichtenstein (the Level-trial): A Randomised Controlled Trial
*H.H. Eker1, *H.R. Langeveld1, *W.F. Weidema2, *L.P.S. Stassen3, *E.W. Steyerberg1, H.J. Bonjer1, *J.F. Lange1, J. Jeekel1
1Erasmus Medical Center, Rotterdam, Rotterdam, Netherlands2Ikazia Ziekenhuis, Rotterdam, Rotterdam, Netherlands3Reinier de Graaf gasthuis, Delft, Netherlands
OBJECTIVE(S): Comparison of minimally invasive versus open inguinal hernia repair. Although mesh repair is generally preferred for surgical correction of inguinal hernia, it is still debated whether open or endoscopic techniques should be used. In this study, the most common technique for open mesh repair (Lichtenstein) was compared with the currently preferred minimally invasive technique (total extra peritoneal, TEP).
METHODS: In this multi center trial, 660 patients were randomised to either Lichtenstein or TEP. Primary outcome was postoperative pain. Recurrences, complications, operating time, hospital stay, period until complete recovery, QoL, chronic pain and costs were secondary endpoints.
Three-hundred-thirty-six patients were randomised to TEP and 324 to Lichtenstein repair. TEP was associated with less postoperative pain until 6 weeks postoperatively (p=0.01). Impairment of inguinal sensibility was less seen after TEP (7% versus 30%, p=0.01). Peroperative complications were more frequent after TEP (6% versus 2%, p<0.001), while there was no difference in length of hospital stay. Postoperative complications (33% versus 33%) and QOL were comparable. After TEP, patients had a faster recovery of daily activities (ADL) (p<0.002) and less absence from work (p=0.001). After a mean follow-up of 66 months, recurrences and total costs were comparable for both groups.
CONCLUSIONS: Although TEP procedure was associated with more preoperative complications, postoperative recovery was faster with less postoperative pain, faster recovery of daily activities, quicker return to work, and less impairment of inguinal sensibility after 1 year. Recurrence rates and incidence of chronic pain were comparable. TEP can be recommended in experienced hands.