Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost

Abstract

Objective: To compare tension-free open mesh hernioplasty under local anaesthetic with transabdominal preperitoneal laparoscopic hernia repair under general anaesthetic.

Design: A randomised controlled trial of 403 patients with inguinal hernias.

Setting: Two acute general hospitals in London between May 1995 and December 1996.

Subjects: 400 patients with a diagnosis of groin hernia, 200 in each group.

Main outcome measures: Time until discharge, postoperative pain, and complications; patients' perceived health (SF-36), duration of convalescence, and patients' satisfaction with surgery; and health service costs.

Results: More patients in the open group (96%) than in the laparoscopic group (89%) were discharged on the same day as the operation (chi2 = 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 ratio at 2 hours 3.5 (2.3 to 5.1)), scores after open repair were significantly higher for each day of the first week (0.5 (0.3 to 0.7) on day 7) and during the second week (0.7 (0.5 to 0.9)). At 1 month there was a greater improvement (or less deterioration) in mean SF-36 scores over baseline in the laparoscopic group compared with the open group on seven of eight dimensions, reaching significance on five. For every activity considered the median time until return to normal was significantly shorter for the laparoscopic group. Patients randomised to laparoscopic repair were more satisfied with surgery at 1 month and 3 months after surgery. The mean cost per patient of laparoscopic repair was 335 pounds (95% confidence interval 228 pounds to 441 pounds) more than the cost of open repair.

Conclusion: This study confirms that laparoscopic hernia repair has considerable short term clinical advantages after discharge compared with open mesh hernioplasty, although it was more expensive.

Figure 1

Design of trial and outcome measures of laparoscopic v open repair of inguinal hernia

Figure 2

Proportion of patients not yet discharged from hospital over time. Median times (hours) to discharge 6.00 for laparoscopic patients and 5.17 for open patients. Hazard ratio of discharge for open relative to laparoscopic 2.17 (1.73 to 2.72)

Figure 3

Survival curve showing proportion of patients not yet returned to usual activities around house over time after hernia repair

Figure 4

Survival curve of total cost showing proportion of patients who have consumed resources valued over specific costs. Patients for whom postoperative cost data at 1 or 3 months were missing have been censored. Three open and three laparoscopy patients had costs over £1200