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

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 hernia-specific 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.