Randomised controlled trial of laparoscopic versus open mesh repair for inguinal hernia: outcome and cost |
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| Authors: | James Wellwood Mark J Sculpher David Stoker Graham J Nicholls Cathy Geddes Anne Whitehead Rameet Singh David Spiegelhalter |
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| Affiliation: | aWhipps Cross Hospital, London E11 1NR, bHealth Economics Research Group, Brunel University, Uxbridge, Middlesex UB8 3PH, cNorth Middlesex Hospital, London N18 1QX, dMedical and Pharmaceutical Statistics Research Unit, University of Reading, PO Box 240, Reading RG6 6FN, eMRC Biostatistics Unit, Institute of Public Health, Cambridge CB2 2SR |
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| 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 (χ2=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 (95% confidence interval £228 to £441) 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. Key messages - In the 4 hours after surgery laparoscopic hernia repair with general anaesthesia causes more pain than open repair with local anaesthesia (mainly because of the anaesthesia used) and necessitates longer stay in hospital. Laparoscopic hernia repair, however, causes less pain than open hernia repair during the first 2 weeks after discharge
- Laparoscopic hernia repair results in fewer episodes of wound infection, persistent local pain, genital swelling, numbness, and constipation than open repair. Urinary disturbances are more common after laparoscopic than after open repair
- Patients’ perception of health 1 month after the operation (assessed with the SF-36) and satisfaction with treatment is superior for laparoscopic patients who also have a shorter period of convalescence after surgery
- The health service cost of day case laparoscopic repair is £335 more than the cost of open mesh hernioplasty performed on a day case basis
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