Drs. Milsom and Hammerhofer review some of the controversies surrounding the use of laparoscopic procedures in the management of colorectal cancers. They detail the approach followed in the development of their technique, and outline the phase 3 clinical trials that they are currently conducting, which are aimed at demonstrating the usefulness and appropriateness of laparoscopic colon resection for the treatment of colorectal cancers.
The authors conclude that all attempts at laparoscopic colon resection for potentially curable colon cancers should be restricted to centers engaged in prospective, double-blind, randomized clinical studies. They offer three reasons for this conclusion:
1) The procedure is a "new" technique with unproven morbidity, mortality, and long-term results.
2) It is technically more challenging, more time consuming, and expensive than conventional surgery.
3) Laparoscopic colon resection has already been reported to have the complication of trocar site recurrences.
All three points have validity, and are nicely addressed in Milsom and Hammerhofer's review. However, I do not believe that either the technical, practical, cost issues, or the problem of port site recurrences, by themselves, justify restricting the use of the technique to those centers that are conducting prospective, double-blind, randomized clinical studies, as suggested by Milsom and Hammerhofer. Only the first reason cited by the authors-the lack of data on results-would justify limiting the application of the technique to such settings.
A similar conclusion about laparoscopic cholecystectomy was reached in an editorial published in early 1990.1 If this suggestion had been followed, we would still be awaiting the acceptance of laparoscopic cholecystectomy. We therefore have to be very careful when making such broad statements; we must ask ourselves what we are trying to accomplish, and what is the best way of achieving that goal.
Neither Unfounded nor Unproven
When a new therapy is unfounded and needs validation before it is applied to a human model, it must undergo the scrutiny of the scientific community. The most accepted way of validating a new therapy is through a prospective, randomized, double-blind study. Even though this form of study is held to be the ultimate scientific "proof" substantiating a particular claim, it is not always feasible or ethical to insist upon this evidence before offering a therapy to the general public . The question, therefore, is whether laparoscopic colon resection for colorectal cancers is a "new" therapy, and, if it is, must its efficacy be demonstrated in a prospective, randomized, double-blind study before it can be offered to the general community?
I believe that laparoscopic colon resection for resectable colon malignancies is neither unfounded nor totally unproven. The principles of oncologic surgery are well known and have been documented in the case of open colon resection. As Milsom and Hammerhofer point out in the beginning of their paper, the only major difference between an open and laparoscopic technique is access to the intraperitoneal pathology. Given this fact, it is reasonable to propose that if the technique of resection during laparoscopic colon surgery reproduces the technique of an open procedure, the results should be the same, and thus, a double-blind study would be unnecessary.
The authors review their own work, which demonstrates, in both an animal model and cadavers, that the principles of oncologic resection can be duplicated in a laparoscopic procedure. Similar work done by other investigators [3,4] further supports this claim. It is therefore reasonable to offer laparoscopic colon resection for the treatment of resectable colon cancers, provided that patients are well-informed and counseled regarding the "newness" of the technique.
Even if we accept the need for a double-blind, randomized, prospective study, I do not think that it is ethical or appropriate to restrict the use of this procedure to only the larger institutions. Requiring participation in a randomized prospective doubleblinded study essentially achieves this result, since it is difficult for individual "community" surgeon to run this sort of study due to the lack of resources. With the given experience in laparoscopic colon surgery, I feel that many of these "community" surgeons have a high degree of expertise in the laparoscopic approach, and it would be a shame to deny their patients the benefits of this expertise. We cannot forget that the roots of the laparoscopic movement in general surgery are in the clinical community, not the academic centers. Most of the original work on laparoscopic colon surgery had its beginnings with the community surgeon.
Training and Credentialing More Important
The real problem posed by "unleashing" laparoscopic colon surgery for colorectal cancers is whether the general population of surgeons performing laparoscopic colon resections can, in fact, duplicate the principles of oncologic resection. I have no doubt that surgeons well-trained in laparoscopy can achieve this goal. Whether this is also true of the "average surgeon," who may not yet have developed the skills required to achieve a proper oncologic resection, is less clear. This issue will not be resolved by a double-blind clinical study, but rather, will be addressed more efficiently by careful attention to training and credentialing.
Establishing a general registry (such as the one established by the American Society of Colon and Rectal Surgeons), to which all surgeons performing the technique of laparoscopic colon resection can contribute data, will yield far better information regarding who can or should be performing laparoscopic colon resection. The data generated by this registry can then be compared to historical data on open colon resection, and further answer questions regarding costs, operating room time, complications, and long-term results.
This is not to say that there is no value to a prospective, randomized, double-blind study. This form of study is still the ultimate scientific documentation. I just do not agree with Milsom and Hammerhofer's statement that laparoscopic resection for colon cancer needs to be limited to certain centers. If we were to follow this course of action, we might be unnecessarily delaying acceptance of a potentially useful therapy, as would have occurred had clinicians heeded a similar recommendation regarding laparoscopic cholecystectomy made a few years ago!