Randomized clinical trial comparing total extraperitoneal with Lichtenstein inguinal hernia repair (TEPLICH trial).

Abstract

Chronic pain is reported after 10-35 per cent of inguinal hernia operations. The aim was to compare quality of life (QoL) after total extraperitoneal (TEP) and Lichtenstein hernia repairs in the setting of an RCT with operations performed by department-certified hernia surgeons. Men aged 30-75 years with an ASA grade I-II primary inguinal hernia were randomized to TEP or Lichtenstein repair. Primary endpoint was pain at 1 year assessed with the Inguinal Pain Questionnaire (IPQ). Clinical examination, IPQ, SF-36® and study-specific questions were recorded before surgery, and at 1 and 3 years. Some 416 patients (202 TEP and 214 Lichtenstein) had surgery; 95·2 per cent completed 1-year and 89·9 per cent 3-year follow-up. At 1 year 'pain during last week' was reported by 6·9 per cent after TEP and by 9·8 per cent after Lichtenstein repair (P = 0·303), and 'pain right now' by 3·7 and 5·9 per cent respectively (P = 0·315). Favourable outcomes for TEP were duration of operation, 30-day complications, time to full recovery, foreign body sensation and sick leave. Groin sensory changes diminished after TEP but increased after Lichtenstein repair. Preoperative QoL was affected, especially in the physical subscales, but was restored to normal after surgery. At 1 and 3 years, 98·3 and 97·4 per cent respectively of the patients were satisfied; 1·6 per cent (6 of 374) suffered a recurrence at 3 years, four after TEP and two after Lichtenstein repair. In the medium term, both TEP and Lichtenstein hernia repair had similar outcomes after 1 year, with high rates of patient satisfaction and low rates of chronic pain and recurrence. There were short-term advantages for pain and recovery rate after TEP repair. Registration number: NCT00803985 ( www.clinicaltrials.gov).