Randomised controlled trial of laparoscopic versus open repair of inguinal hernia: early results.

OBJECTIVE: To establish the safety, short term outcome, and theatre costs of transabdominal laparoscopic repair of inguinal hernia performed as day surgery. DESIGN: Randomised controlled trial. The control operation was the two layer modified Maloney darn. SETTING: Teaching hospital and district general hospital. SUBJECTS: 125 men randomised to laparoscopic or open repair of inguinal hernia. OUTCOME MEASURES: Morbidity, postoperative pain and use of analgesics, quality of life, and theatre costs. Outcome was assessed by questionnaires administered to patients daily for 10 days and at six weeks postoperatively and by outpatient review at six weeks. Return to normal activity was assessed by questionnaire at three months. RESULTS: One vascular complication (2%) occurred in the group that had open repair. Seven complications (12%) including vessel injury and early recurrence arose in the group that had laparoscopic repair (difference in complication rate 10% (95% confidence interval 4% to 18%; P = 0.02). Pain scores and quality of life assessed by the short form 36 showed a significant benefit to the group that had laparoscopic repair in the early postoperative period. Return to normal activity was not significantly different between the two groups. Total theatre costs were higher in the group that had laparoscopic repair (mean cost for laparoscopic repair 850 pounds (622 pounds to 1078 pounds); mean cost for open repair 268 pounds (245 pounds to 292 pounds)). CONCLUSIONS: Because of the greater complication rate and higher theatre costs for laparoscopic repair and the patient outcome preferences expressed, the results of larger trials of clinical and cost effectiveness using recurrence as the primary outcome measure should be known before laparoscopic herniorrhaphy is widely adopted.