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Minimal Access Surgery

The expectation is that ten years from now some 70% of surgical operations will be conducted endoscopically. Minimal access surgery (MAS) presents a significant challenge to health care delivery, and the Scottish Office Home and Health Department and Department of Health commissioned an expert working group to consider the implications for patients and the NHS.

Minimal Access Surgery

Chaired by Professor Alfred Cuschieri of the University of Dundee, the working party reminds us that while it took some 40 years for day-case surgery to become a common feature of health care provision, MAS will need more aggressive consideration.

This they have produced, in a readable and thoughtful booklet available from HMSO. To precis the booklet is not possible. It considers all aspects of the introduction of MAS including management issues, costs, equipment and theatre design, training and guidelines for safe MAS, clinical audit and research. It is clear that there will need to be much new thinking, and health authorities and Trusts should take advantage of the working groups thoughtful words.

As a flavour of what the booklet contains, the conclusions are:-
  • MAS is distinctive because of the reduced trauma of access. From this stem all of its advantages.
  • MAS is, like day surgery, a short-stay specialty, which requires the same level of specialisation in facilities and staff; the same management efficiency; and corresponding new attitudes and work practices.
  • High throughput within designated MAS units is essential for acceptable levels of expertise to be developed and maintained, and to justify high capital investment.
  • MAS is estimated in 10 years time to account for 70% of all surgical operations. It has major implications for NHS planning and contracting.
  • The overall impact on NHS costs is unlikely to be significant, but there are substantial gains in the quality of treatment and acceptability to patients, and in savings in sickness and other benefits.
  • The specialised equipment for MAS requires a high level of efficiency and maintenance. Sterilisation of instruments is a particular concern.
  • Safe practice of MAS should be ensured through appropriately regulated training and certification.
  • The speed of introduction of MAS presents a major challenge to maintenance of a high quality service in the NHS. Systematic clinical audit, supervised by a recognised, authoritative group, should be mandatory, to monitor outcomes particularly in the longer term. Guidelines and protocols for good practice should be developed.
  • Research is urgently required particularly in relation to development of equipment; biological implications; appropriate use; and outcomes. Appropriate methods of clinical evaluation should be developed.
Research urgently required

This last point in the recommendations is especially important, as the premise is that MAS is going to be the technique of the future in any event. In 1784 Moore wrote "man may wish to publish what he believes will be of public utility, and may think that even the probability of saving severe torture of some of his fellow creatures a stronger reason for doing so immediately, than the risk of offering a defective performance to the Public of delaying it."

Two hundred years later we have a similar dilemma with minimal access interventions. A Luddite stance is unrealistic - the problems lie in the manner in which we assess the techniques, in the timing of the assessment in the development. Done too late we may struggle to stop a harmful technique after widespread investment.

Can it .... Should it be done?

There are several stages in the process of evaluating new techniques. Two important questions are "Can it be done?" followed by "Should it be done?". Often it seems that if a technique is feasible we assume that it should be done. Evaluating the "Should it be done?" question has to include adverse effect outcomes. There are then two problems for the RCT against the established procedures.
  • One is the size of the study. If there are serious adverse outcomes with high incidence then these should be identified in even a small study. Serious outcomes with low incidence might be missed in even a moderately large study. These are not new problems, and ever since the thalidomide disaster there has been concern about how best to identify adverse effects when new drugs are introduced.
  • The second problem is the learning curve for the new procedure. If the RCT against established procedures is organised when the operators are still on the steep part of the learning curve then their operating time may be longer and adverse effects incidence higher than if they were experienced. The pressure is on, however, to subject the new procedure to RCT at the earliest possible stage. Doing the trial too early may give the wrong result.
We may have to accept that the early RCT against the established procedure is not going to give us the final answer. Just as when new drugs are introduced there are further stages before we can pronounce on the appropriateness of the new procedure. These further stages would require that operators are on the asymptote of the learning curve and that adequate numbers of patients had been studied to detect low incidence adverse effects.

References:

  1. Moore J. A method of preventing or diminishing pain in several operations of surgery. London, Cadell, 1784.
  2. Minimal Access Surgery (December 1993) is available from HMSO, price £6.50.



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