Surgeons are rushing in to try their hand at minimally invasive operations without proper training or understanding of when they are appropriate.
Keyhole or minimally invasive surgery has been hailed as one of the great medical innovations of the century. Using the latest microtechnology, surgeons can perform major operations, without the trauma of conventional open surgery.
As a result, the patient should be able to leave the hospital quickly often, even an overnight stay is unnecessary and should enjoy a far less painful and speedier recovery.
Although initial research indicates these benefits have still to be fully proven, the technique is the fastest growing in the whole health field. It's already being used in one in five of all abdominal operations, and is likely to be used in 70 per cent of all operations by the end of the century. That would mean that, in the UK alone, it would be used in 2.1 million operations a year, according to current levels.
Quite an elevation for a technique that was introduced as recently as 1990 and whose benefits and dangers have never been scientifically tested.
Keyhole surgery involves making four or five minor incisions usually only five to seven centimetres long through one of which a device called a laparoscope is threaded. The laparoscope is the "eyes" of the surgeon, and a minute lens on its tip transmits pictures of the internal organs onto a video screen.
Other tubular instruments are threaded down the other incisions and the operation takes place via the video screen. If any growth or part of an organ has to be removed, it is first cut away and then compressed and squeezed through the incisions. The technique also involves the use of xenon light beams and lasers.
The laparoscope has been used for over 20 years by gynecologists, but only recently has the technology developed sufficiently to allow instruments to be fitted and used for investigative procedures (say, to check the state of a woman's ovaries), or to cut and perform ligatures (tying up arteries or cutting out tumours).
The entire process usually takes far longer than conventional, open surgery sometimes seven times as long. But surgeons report that patients usually have a far shorter hospital stay afterwards, and can be fully recovered even months sooner than they would be after a conventional operation.
While most experience has been on gall bladder surgery, and increasingly on abdominal procedures, it is a technique that is being used for other diseases. The first operation on cell cancer using laparoscopic equipment was carried out in 1991; the first kidney was removed using the procedure a year earlier.
Surgeons maintain that the escalation of keyhole surgery is patient driven.
While it would be only natural for patients to prefer keyhole surgery to the trauma of a major, invasive procedure, their consent can hardly be informed. There simply hasn't been enough research into the procedure and its after effects for anyone to claim to possess all the facts.
The shortage of beds in many hospitals coupled with the desire of surgeons to try the new technology and not to feel left behind would indicate that pressure is not coming from patients alone.
At a London inquest into the death of a woman who died after receiving a keyhole bowel exploration, it was claimed she had been frightened and confused when the technique was suggested. The surgeon denied this.
Nonetheless, the clinic where the operation was performed banned all laparoscopic procedures until independent experts could confirm that surgeons are qualified to perform the operations.
The reaction of the clinic underlines one of many concerns about keyhole surgery: the lack of training of surgeons. While the training and skills level of the surgeon involved in the inquest case was never in question, it is widely accepted that the general level of skill is low, sometimes dangerously so. In Britain, the government has set aside lb4m to train surgeons specifically in keyhole techniques.
This came as the result of a report by a working party of surgeons headed by keyhole surgery pioneer Professor Alfred Cushieri. The British government has refused to publish the findings which can only lead to speculation that the findings are far more alarming than the currently known facts.
Those facts are bad enough. New York State has reported 158 "adverse incidents" involving keyhole surgery between August 1990 and May 1992. Twenty four of these were "permanent or life threatening", and more than two thirds required further surgery to repair injuries. In the first 26 kidney laparoscopic operations in Washington University, nearly a third suffered complications. Those with major complications had to be operated on again using open surgery (The Lancet, 4 December, 1993).
Serious complications arise in 15 out of every 1000 procedures in gynecological operations, a favoured area for laparoscopic surgery, according to figures from the American Association of Gynecologic Laparoscopists. Three out of every 100,000 patients die as a result of the surgery.
Gynecological surgeons performing laparoscopic procedures seem to fit in one of two camps; they are either "kamikaze surgeons who will push the bounds of this surgery to the outer limits", or they are "as maladroit as a beetle on its back" (J of Gynecol Surg 1989; 5:131-2).
Gall bladder operations (cholecystectomies) are another favourite for laparoscopic techniques. However, in a recent American survey of 77,604 of these operations, over half of the deaths due to the surgery were attributed to complications of the laparoscopic procedure (Amer J of Surg 1993; 165:9-14).
In Britain, the first damages of lb22,500 have been awarded to a woman who may need a liver transplant after a routine gall bladder operation went wrong when the surgeon accidentally cut her bile duct, which leaked and caused jaundice.
Deaths and serious complications are only to be expected with a surgeon untrained in laparoscopic techniques. Instead of the usual "hands on" experience he is used to, he has to have the skills of a video game player. He has to judge three dimensions by using a scope, instead of being able to see the organ in front of him, and then has to manipulate instruments. In a way, he is operating without the sense of touch, and with a different way of seeing.
In one American study in 1991, the incidence of damage to the bile duct fell from 2.2 per cent in the first operations performed to just 0.1 per cent once the surgeon had gained experience (New Eng J Med, 1991; 302:30-1).
A common complication is the puncturing of organs with the microscopic equipment, which accounted for three out of 10,000 complications in gynecological surgery in the US, and occurred in 0.05 per cent of laparoscopic cholecystectomies. Of these, two died as a result of the injury.
Another complication usually among the elderly or those with a heart condition can be triggered by the infusion of carbon dioxide into the stomach, necessary to allow the laparoscope to "see". Sudden irregular heart beat was reported in 17 per cent of patients when carbon dioxide was introduced, according to one British survey. Another study of 49 patients showed that a third suffered a slowing heart rate when the gas was used (Aust NZ J Obstet Gyn 1993; 31:171-173).
In the US, some states do not allow surgeons to perform minimally invasive surgery unless they have been properly trained. In others, as in the UK, surgeons with little or no experience can carry out the procedure. The Society of American Gastrointestinal Endoscopic Surgeons has suggested that surgeons should first carry out procedures on animals before being allowed to operate on people.
Not surprisingly, a study by the University of Iowa showed that complications during and after surgery reduced if the surgeon concerned had been trained in the procedure (JAMA, 8 December, 1993). They suggest that training needs to include a post residency course and "on the job" experience with other surgeons.
But is it safe, even in experienced hands? While the emphasis has been on the surgeon and his lack of experience, a case in Australia also showed up the inadequacy of some of the microtechnology used. One charge of negligence has been filed because the surgeon had not realized that the field of vision through the laparoscope is limited (The Lancet, 11 September 1993). Because the surgeon could not see, a needle entered the patient's colon during the procedure.
If punctures are the most common complications, the spread of disease is potentially the most dangerous. Open surgery in treating cancer carries a high risk of spreading diseased cells to healthy ones, but that risk increases when using keyhole surgery. This is because the surgeon does not have full visibility or control and also because diseased organs and cells have to be squeezed through small incisions, thus increasing the likelihood of diseased cells dropping off and "planting" into healthy organs. This problem was highlighted recently in Cardiff, Wales, where two women who had keyhole surgery on their gall bladders both died from cancer. As the surgeons pulled the malignant tissue through the small hole in the wall of the abdomen, cancer cells broke off and planted themselves in the abdomen.
Does it help for speedier recovery? One of the first major randomized studies comparing removal of the appendix with laparoscopic techniques and conventional, open appendectomy showed there was no difference in postoperative pain and recovery among patients of either procedure.
This is a devastating finding which kicks away one of the platforms on which laparoscopic procedures have been championed.
The study, by the Prince of Wales Hospital in Hong Kong, was based on a comparison of 70 patients who underwent open appendectomy and 70 on whom laparoscopic procedures were performed. Each study group was similar in age, sex ratio and duration of symptoms.
There were no major complications in either group, although 20 per cent of the laparoscopic group had to convert to an open operation.
The research team, headed by Professor J Tate, found no difference between the groups in terms of severity of pain, the need for painkilling drugs, time in reintroducing normal diet, or hospital stay. Similar numbers from both group attended follow up examinations three weeks after surgery, and similar proportions 79 per cent of laparoscopic patients, and 74 per cent of open surgery patients had returned to work (The Lancet, 11 September 1993).
In fairness, it is worth noting that open appendectomy is no longer the major invasive technique it once was, and can now be performed by making a small, muscle splitting incision.
David Lomax, a surgeon from Perth, Australia, believes the argument should pivot more on the type of operation for which laparoscopic surgery is appropriate. It may well become the procedure favoured for operations such as cholecystectomy, but inappropriate for appendectomy and cancer. "Unfortunately, in getting to this stage, many patients will have had complications resulting from this minimally invasive surgery. There are all too many intensive care specialists who know of several admissions to their units necessitated by those complications," he writes in The Lancet (13 November 1993).
Clearly, further research is needed, particularly into the benefits of laparoscopy for other diseases, such as gall bladder problems. The difficulty in assessing any surgical procedure against another by randomized trial is finding surgeons of similar training and experience and patients with a similar medical history and profile. The other problem is the lack of funding to finance the research.
Whereas most clinical trials are funded by the drugs companies, there is no obvious commercial benefactor of a successful trial except the equipment manufacturers.