RANDOMIZED CONTROLLED TRIAL OF LAPAROSCOPIC VERSUS OPEN MESH REPAIR FOR INGUINAL-HERNIA - OUTCOME AND COST

Objective: To compare tension-free open mesh hernioplasty under local anaesthetic with transabdominal preperitoneal laparoscopic hernia repa ir under general anaesthetic. Design: A randomised controlled trial of 403 patients with inguinal hernias. Setting: Two acute general hospit als in London between May 1995 and December 1996. Subjects: 400 patien ts with a diagnosis of groin hernia, 200 in each group. Main outcome m easures: Time until discharge, postoperative pain, and complications; patients' perceived health (SF-36), duration of convalescence, and pat ients' satisfaction with surgery; and health service costs. Results: M ore patients in the open group (96%) than in the laparoscopic group (8 9%) were discharged on the same day as the operation (chi(2) = 6.7; 1 df; P = 0.01). Although pain scores were lower in the open group while the effect of the local anaesthetic persisted (proportional odds rati o at 2 hours 3.5 (2.3 to 5.1)), scores after open repair were signific antly higher for each day of the first week (0.5 (0.3 to 0.7) on day 7 ) and during the second week (0.? (0.5 to 0.9)). At 1 month there was a greater improvement (or less deterioration) in mean SF-36 scores ove r baseline in the laparoscopic group compared with the open group on s even of eight dimensions, reaching significance on five. For every act ivity considered the median time until return to normal was significan tly shorter for the laparoscopic group. Patients randomised to laparos copic repair were more satisfied with surgery at 1 month and 3 months after surgery. The mean cost per patient of laparoscopic repair was po und 335 (95% confidence interval pound 228 to pound 441) more than the cost of open repair: Conclusion: This study confirms that laparoscopi c hernia repair has considerable short term clinical advantages after discharge compared with open mesh hernioplasty, although it was more e xpensive.