Elsevier

The Lancet

Volume 354, Issue 9174, 17 July 1999, Pages 185-190
The Lancet

Articles
Laparoscopic versus open repair of groin hernia: a randomised comparison

https://doi.org/10.1016/S0140-6736(98)10010-7Get rights and content

Summary

Background

Repair of a groin hernia is one of the most common elective operations performed in general surgery. Our aim was to compare laparoscopic repair with open repair of groin hernia.

Methods

At 26 hospitals in the UK and lreland, 928 patients with groin hernia were randomly assigned to laparoscopic repair (n=468) or open hernia repair (n=460, of which 433 were tension-free mesh repairs). Patients were clinically assessed at 1 week and 1 year after surgery, and were sent questionnaires at 3 months and 1 year. The primary endpoints were: complications: return to usual activities of social life (as the most generally applicable example of return to usual activities); hernia recurrence; groin pain that persisted at 1 year; and costs to the health services. All analyses were by intention to treat.

Findings

At 1 week, at least one complication was found in 108 (29·9%) patients allocated to laparoscopic repair and in 155 (43·5%) patients allocated to open repair (95% CI for difference −20·6% to −6·6%, p<0·001). There were three serious surgical complications all of which occurred in the laparoscopic group. Patients in the laparoscopic group returned to the usual activities of social life sooner than the patients in the open repair group (10 [IQR 7–21] vs 14 [7–28] days, p=0·004). At 1 year after the operation, the laparoscopic group had a lower rate of persistent groin pain than those who had open repair (28·7% vs 36·7% [95% CI for difference −14·7% to −1·4%], p=0·0018). Hwever, all seven hernia recurrences occurred in the laparoscopic group not in the open repair group 1·9% vs 0·0% [95% Clfor difference 0·5% to 3·4%], p=0·0017).

Interpretation

Although laparoscopic hernia repair has advantages for patients, concerns about safety indicate that open repair is the more appropriate option for the general surgeon. Our findings lend support to the move towards laparoscopic hernia surgery becoming part of the domain of specialist surgeons.

Introduction

Repair of a groin hernia is one of the most common elective operations in general surgery: rates range from ten per 10000 of the population in the UK to 28 per 10000 in the USA.1 Long-term follow-up indicates that 15–30% of all hernia repairs will fail, and 60% of these will cause symptoms.2 Because of such rates of recurrence after sutured hernia repair, the concept of tension-free mesh repair has gained wide acceptance. Anterior and preperitoneal approaches with or without mesh fixation have been undertaken. Recurrence rates of less than 1% without any case of mesh rejection have been reported from specialised hernia centres for anterior tension-free approaches. Some investigators recommend the preperitoneal prosthetic mesh repair as the procedure of choice for recurrent and large bilateral hernia.3 By contrast, other researchers suggest that prosthetic material is unnecessary in patients with indirect hernias and a normal posterior wall, and therefore recommend tailoring of hernia repair according to type of hernia and patient.4

Laparoscopic hernia repair is similar to the open preperitoneal approaches and is performed trans-abdominally or totally extraperitoneally. Unlike laparoscopic cholecystectomy, this procedure has been slow to gain acceptance. This reluctance is mainly because of reports of rare serious complications during and after surgery which include visceral, vascular, and nerve injury, and small bowel obstruction. A further drawback has been the long learning curve associated with these techniques and a high rate of failure to repair the hernia in this transitional learning period for the surgeon.5

We report a pragmatic multicentre, randomised, controlled comparison of open repair versus laparoscopic repair of a groin hernia.

Section snippets

Patients

27 consultant surgeons from 26 hospitals in the UK and Ireland took part in this trial, which was approved by the relevant local research ethics committees. All surgeons had previous experience of at least ten laparoscopic hernia repairs. Surgeons who felt that they were still learning the technique were visited by an experienced surgeon who gave them additional training and observed each surgeon doing the hernia repair.

Patients were recruited between January, 1994, and March, 1997. All

Characteristics of groups at trial entry

The study identified 1619 potentially eligible cases of hernia. 928 patients gave their consent and were randomised, including seven who were randomised twice for separate hernias (figure). The main reasons for non-randomisation were: 159 (23·1%) patients who were not eligible; 132 (19·2%) patients whose surgeons were not eligible; 121 (17·6%) patients refused to take part, 99 (14·4%) patients had suspected spoilt randomisation envelopes; and 92 (13·4%) patients had surgeons who did not want to

Discussion

In this large multicentre randomised trial, laparoscopic hernia repair was associated with earlier return to usual activities and less persistent groin pain 1 year after the operation, but with more serious surgical complications, hernia recurrences, and higher estimated cost to the health service.

These estimated differences are unlikely to be affected by bias.9 Most participants were formally entered by means of a centralised telephone randomisation service. To be sure of no selection bias

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