Unlocking keyhole surgery

Randomised controlled trials of surgical interventions are not common. Laparoscopic techniques are fashionable, and in some situations are now used widely. Repair of inguinal hernia is frequently carried out as a day-case procedure, so advantages of laparoscopic techniques are less likely to be apparent. Even so, results from well conducted RCTs examining a number of outcomes are welcome.

Design

A recent study [1] randomised patients having day-case hernia repairs to open or laparoscopic surgery (with full details of the type of procedure detailed in the original article). Surgery was performed by four surgeons who were experienced laparoscopists, and the operations were carried out under general anaesthesia.

Patients were given supplies of analgesic tablets (diclofenac, co-proxamol and pethidine) for different degrees of discomfort and were told that they could return to work or normal activity as soon as they wished. Questionnaires were administered to the patients for the first 10 postoperative days, and at six weeks.

Outcome measures

The principal outcome was the rate of short-term complications - an accidental event or secondary disease process resulting from the operation and occurring within 6 weeks. Other outcomes were daily pain scores, a profile of health status, time to return to work, and resource consumption.

Results

Complications occurred more frequently (7/58 patients) with laparoscopy compared with open operations (1/66). The number needed to treat with laparoscopic techniques to produce one extra complication was 9 (95%CI 5 - 60).

Laparoscopic surgery produced less pain in the days after surgery both on movement and on coughing, but not at rest. There was also a significant trend to lower tablet consumption with laparoscopic surgery, but using tablet consumption of more or less than 10 tablets as a surrogate for overall pain, there was no significant difference - 34/55 taking fewer than 10 tablets after laparoscopic surgery compared with 38/66 after open surgery, odds ratio 1.0 (95%CI 0.5 - 2.2). The median time to return to work was 22 days after laparoscopic repair, compared with 28 days after open repair.

Laparoscopic repair was the more expensive option. This operation had an average cost of £850 compared with £268 for open repair.

Comment

This well conducted study from the Health Services Research Unit and Department of Surgery at Oxford showed that on current evidence laparoscopic procedures for hernia repair are associated with more short term risks and higher cost, with some marginal benefits in postoperative pain. The authors conclusion is that results of larger trials of different surgical techniques should be known before this technology is widely adopted.

Reference:

K Lawrence, D McWhinnie, A Goodwin et al. Randomised controlled trial of laparoscopic versus open repair of inguinal hernia: early results. British Medical Journal 1995 311: 981-5.

previous or next story in this issue