RANDOMIZED CONTROLLED TRIALS Total Extraperitoneal Inguinal Hernia Repair Compared With Lichtenstein (the LEVEL-Trial) A Randomized Controlled Trial Hester R. Langeveld, MD,* Martijne van’t Riet, MD,† Wibo F. Weidema, MD,‡ Laurents P. S. Stassen, MD,† Ewout W. Steyerberg, PhD,§ Johan Lange, MD, PhD,* Hendrik J. Bonjer, MD, PhD,¶ and Johannes Jeekel, MD, PhD* Background: This randomized controlled trial was designed to compare the most common technique for open mesh repair (Lichtenstein) with the currently preferred minimally invasive technique (total extra peritoneal, TEP) for the surgical correction of inguinal hernia. Methods: A total of 660 patients were randomized to Lichtenstein or TEP procedure. Primary outcomes were postoperative pain, length of hospital stay, period until complete recovery, and quality of life (QOL). Recurrences, operating time, complications, chronic pain, and costs were secondary endpoints. This study was registered at www.clinicaltrials.gov and carries the ID: NCT00788554. Results: About 336 patients were randomized to TEP, and 324 to Lichten- stein repair. TEP was associated with less postoperative pain until 6 weeks postoperatively (P = 0.01). Chronic pain was comparable (25% vs. 29%). Less impairment of inguinal sensibility was seen after TEP (7% vs. 30%, P = 0.01). Mean operating time for a unilateral hernia with TEP was longer (54 vs. 49 minutes, P = 0.03) but comparable for bilateral hernias. Incidence of adverse events during surgery was higher with TEP (5.8% vs. 1.6%, P  0.004), but postoperative complications (33% vs. 33%), hospital stay and QOL were similar. After TEP, patients had a faster recovery of daily activities (ADL) and less absence from work (P = 0.01). After a mean follow-up of 49 months, recurrences (3.8% vs. 3.0%, P = 0.64) and total costs (€3.096 vs. €3.198) were similar. Conclusion: TEP procedure was associated with more adverse events during surgery but less postoperative pain, faster recovery of daily activities, quicker return to work, and less impairment of sensibility after 1 year. Recurrence rates and chronic pain were comparable. TEP is recommended in experi- enced hands. (Ann Surg 2010;251: 819 – 824) C orrection of inguinal hernias is one of the most common surgical procedures. 1 The optimal method for repair remains a matter of debate, despite extensive research. The use of prosthetic mesh, to create tension-free repair, is preferable over non mesh techniques because of reduced recurrence. 2–7 The mesh can be placed with either open or endoscopic surgery. The hernia repair according to Lichtenstein is the most commonly used mesh tech- nique in open surgery. 8 The total extraperitoneal inguinal hernio- plasty (TEP) is the current preferred endoscopic mesh technique. A large randomized head to head comparison of only TEP and Lichtenstein repair has not previously been performed. We therefore designed a randomized trial; the “LEVEL”-trial, to com- pare TEP with Lichtenstein regarding postoperative pain, length of hospital stay, period until recovery, and quality of life. A long-term evaluation with 660 patients was performed in which we focused largely on postoperative pain. METHODS Six hospitals, including 1 university hospital in the Nether- lands participated in the “LEVEL”-trial. All centers obtained ap- proval of their Medical Ethical Committee for participating. Adults presenting with primary or recurrent inguinal hernias, uni- or bilat- eral, with an indication for elective correction, were eligible for randomization. Exclusion criteria were scrotal hernia, pregnancy, and communicative or cognitive limitation that prevented informed consent. A medical history of prostatectomy, pfannenstiel inci- sion, preperitoneal procedure, or abdominal bladder operation were other reasons for exclusion. Written informed consent was obtained before randomization. Randomization for TEP or Lich- tenstein was carried out by telephone or fax at the outpatient clinic, by the central study coordinator, according to a balanced and stratified computer-generated list. Stratification was by cen- ter, recurrence state (primary, first recurrence, or  second recurrence), uni- or bilateral hernia and clinical or day-care treatment. The trial is registered at www.clinicaltrials.gov with number NCT00788554. Surgical Technique Surgeons and residents were experienced with both proce- dures or were supervised by an experienced surgeon. For TEP, a surgeon who previously performed a minimum of 100 laparoscopic interventions and a minimum of 30 endoscopic corrections of inguinal hernias had to be present in the operating room throughout the whole procedure. Experience of the surgeon or resident who performed the operation was registered. Experience was reported as: “Level 1” (experience with less than 10), “Level 2” (10 –25), or “Level 3” (more than 25 procedures). Both procedures were performed under standardized tech- niques. Use of prophylactic antibiotics was up to the surgeon and reported. The open tension-free mesh hernioplasty was performed ac- cording to Lichtenstein. 2,8 General, local, or spinal anesthesia was used. The hernia sac was dissected and reduced to the preperitoneal From the *Department of Surgery, Erasmus MC, Rotterdam, The Netherlands; †Department of Surgery, Reinier de Graaf Groep, Delft, The Netherlands; ‡Department of Surgery, Ikazia ziekenhuis, Rotterdam, The Netherlands; §De- partment of Public Health, Erasmus MC, Rotterdam, The Netherlands; and ¶Department of Surgery, Dalhousie University, Halifax, Canada. Supported by a grant from the Erasmus Medical Center Healthcare Efficiency research program (VAZ-doelmatigheids-onderzoek). The Healthcare Efficiency research program did not play a role in study design; in the collection, analysis, and interpretation of data; in the writing of the report; and in the decision to submit the paper for publication. Reprints: Hester R. Langeveld, Erasmus Medical Centre, Department of surgery, PO Box 2040, 3000 CA Rotterdam, The Netherlands. E-mail: h.langeveld@erasmusmc.nl. Copyright © 2010 by Lippincott Williams & Wilkins ISSN: 0003-4932/10/25105-0819 DOI: 10.1097/SLA.0b013e3181d96c32 Annals of Surgery • Volume 251, Number 5, May 2010 www.annalsofsurgery.com | 819