BMJ 1995;311:981-985 (14 October)

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

Kate Lawrence, Medical Research Council training fellow,a Douglas McWhinnie, honorary consultant surgeon,b Alex Goodwin, senior registrar in anaesthetics,c Helen Doll, statistician,a Andrew Gordon, clinical tutor in surgery,b Alistair Gray, health economist,d Julian Britton, consultant surgeon,b Jack Collin, reader in surgery b

a Health Services Research Unit, Department of Public Health and Primary Care, University of Oxford, Oxford OX2 6HE, b Nuffield Department of Surgery, University of Oxford, c Nuffield Department of Anaesthetics, University of Oxford, d Centre for Socio-legal Studies, Wolfson College, University of Oxford

Correspondence to: Mr D McWhinnie, Milton Keynes General Hospital Trust, Eaglestone, Milton Keynes M6 5AZ.

Abstract

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 pounds sterling850 (pounds sterling622 to pounds sterling1078); mean cost for open repair pounds sterling268 (pounds sterling245 to pounds sterling292)).
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.

Key messages

  • Key messages

  • Laparoscopic repair was associated with a higher risk of complication than open repair

  • Return to normal activity was not significantly different between the two groups, with social class explaining more of the variance in this outcome than the type of operation received

  • Theatre costs were higher for the group that had laparoscopic repair owing to the cost of laparoscopic consumables and the increased operating time (only 15% of costs were explained by the surgeons' learning curve)

  • Seventy four per cent of patients regarded long term recurrence as the most important outcome, and the results of larger scale, long term trials examining this outcome should be awaited before laparoscopic repair is widely adopted


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