Discomfort five years after laparoscopic and Shouldice inguinal hernia repair: a randomised trial with 867 patients. A report from the SMIL study group.

BACKGROUND: In recent years long-term discomfort after inguinal hernia surgery has become an issue of great concern to hernia surgeons. Long-term results on discomfort from large randomised studies are sparse. METHODS: One-thousand one-hundred and eighty-three patients were randomised in a multicentre trial with the primary aim of comparing recurrence rates after laparoscopic TAPP and Shouldice repair. Evaluating late discomfort and its possible risk factors were secondary objectives, and are reported here. The patients were clinically examined after 1 and 5 years, and answered questionnaires 2 and 3 years postoperation. RESULTS: Of 1,068 operated patients, 867 were eligible for analysis after 5 years (81.2%). The percentage of patients experiencing discomfort of any kind were 8.5% in the TAPP group and 11.4% (p = 0.156) in the Shouldice group. Although discomfort was usually mild it was severe for 0.2 and 0.7%, respectively. Severe pain the first postoperative week was a risk factor for late discomfort in the Shouldice group (OR 2.25, P = 0.022) but not in the TAPP group. No other risk factor for late discomfort was found. CONCLUSION: There was no difference between late discomfort at five-year follow-up after laparoscopic TAPP and Shouldice repair. Discomfort was mostly mild and pain during the first postoperative week was a prognostic variable for late discomfort in Shouldice patients.