Patient-assessed outcome up to three months in a randomised controlled trial comparing laparoscopic with open groin hernia repair

Abstract

The objective was to compare laparoscopic with open groin hernia repair in respect of patient-assessed outcome up to three months post-operatively. As part of a multicentre pragmatic trial 716 patients were recruited in 13 UK hospitals and randomly assigned to receive laparoscopic or open repair. Most participants were men (95%) with unilateral hernias (92.5%) which were inguinal (98.5%). Questionnaires were completed one week, one month, and three months after surgery. The principal endpoints were groin pain and return to usual social activities. The other outcomes were herniaspecific questions and the SF-36, EQ-5D and HADS measures. All analyses were by intention to treat. At one week and one month, respectively 10.3% and 13.9% fewer people in the laparoscopic group had groin pain and 27.7% and 37.2% fewer had numbness (all P < 0.001). Return to usual social activities was quicker in the laparoscopic group (P = 0.01). The laparoscopic group also had significantly more favourable scores at one week in five SF-36 subscales (physical functioning (P < 0.001), social functioning (P = 0.004), role physical (P < 0.001), role mental (P = 0.003) and pain (P < 0.001)), the EQ-5D utility score (P = 0.003) and the depression subscale of HADS (P = 0.001), and at one month in two SF-36 subscales (physical functioning (P = 0.01) and role physical (P = 0.01)). There was no detectable advantage by three months. Our findings that short-term outcome was better for patients allocated laparoscopic repair are consistent with other trials.