Department of Surgery, The Ohio State University Medical Center, 327 Means Hall,
1654 Upham Drive, Columbus, OH 43210, USA
b
Division of General Surgery, University of South Florida College of Medicine,
Tampa General Hospital, P.O. Box 1289, Room F145, Tampa, FL 33601, USA
* Corresponding author.
E-mail address: christopher.ellison@osumc.edu (E.C. Ellison).
0039-6109/08/$ - see front matter 2008 Elsevier Inc. All rights reserved.
doi:10.1016/j.suc.2008.05.007
surgical.theclinics.com
928
use of lasers was the only way to deliver cutting and coagulating energy to
the gallbladder bed. General surgeons who did not do this procedure
quickly saw referrals disappear. As cholecystectomy was the most common
procedure done by general surgeons at the time, with approximately
500,000 cases per year, the scal success of the general surgery practice
was in some part dependent of the volume of these procedures. Surgery is
not immune to capitalism; hence, there was a frenzy to learn the technique
and establish a program at surgeons hospitals and an equal frenzy to provide courses for training surgeons and their operative teams. There was no
organized eort to credential and codify these training programs; the process simply did not exist. Some of these courses were good, including didactic, video, and instruction with inanimate models; the predecessor to
simulation was a black box with a laparoscopic camera system and
hands-on procedures in animal models that emphasized team training.
Others were less comprehensive. All gave a certicate of attendance but usually not prociency and the course did not certify competence. Surgeons
usually ascertained their own prociency. Studies have shown that students
may overestimate their performance and skill level during laparoscopic
training courses [2]. In addition, hospitals had limited guidelines for credentialing. They were facing the same economic pressures as the surgeons and
wanted a program to be established. Not infrequently, surgeons taking one
of these courses would return home and almost immediately schedule
patients. Initially, two surgeons usually worked together on the rst few
cases, but there were no established guidelines or recommendations for preceptoring by surgeons trained in the procedure. Although patient outcomes
in most instances were good, they were not good enough. There were all too
many complications, resulting in a public outcry.
Training, credentialing, and awarding of privileges of practicing
surgeons in new technology
The impact of the perfect storm created by the introduction of laparoscopic cholecystectomy led to a response by academic and organized surgery
in partnership with industry to take the lead in training practicing surgeons
in new techniques. The Society of American Gastrointestinal Endoscopic
Surgeons (SAGES) moved quickly with guidelines for credentialing in laparoscopic cholecystectomy [3]. The guidelines recognized that the procedure
was eective and safe but that it required training in animal models and that
the rst cases should be preceptored by an experienced surgeon [4]. The
American College of Surgeons (ACS) responded with reorganization of its
Division of Education and the addition of the Committee on Emerging
Surgical Technology and Education (Fig. 1). In June of 1994, the ACS
published a statement on emerging surgical technologies and guidelines
for the evaluation of credentials of individual surgeons for the purpose of
awarding surgical privileges (Box 1) [5]. In 1995, the ACS presented
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Fig. 1. Standing committees of the ACS Division of Education. The addition of the Committee
on Emerging Surgical Technology and Education followed the advent of laparoscopy.
930
931
programs that have given practicing surgeons access to learning new techniques.
Successes have been achieved in bariatric surgery, sentinel lymph node biopsy,
and endovascular procedures. American surgery and industry responded eectively to the publics need for a process by which to introduce new technology.
As the minimally invasive revolution began to evolve, more and more
complex procedures adapted to a laparoscopic approach, including inguinal
hernia repair, Nissen fundoplication, Roux-en-Y gastric bypass, colon resections, splenectomy, and adrenalectomy. The bad experience with the introduction of laparoscopic cholecystectomy was not repeated because of the
eorts of organized surgery, industry, and the surgical profession. The speed
of development and widespread acceptance of these more complex procedures was more controlled and less media driven. A mechanism to ensure
the appropriate training and preceptoring of surgeons was available in
many circumstances. Hospitals and credentialing authorities were more
aware of the need for these experiences before awarding surgeons clinical
privileges to perform a certain new minimally invasive procedure without
supervision. The revolution became an evolution.
Training of new technology to fellows and residents in surgery
Another challenge that arose from laparoscopic cholecystectomy was how
to introduce this new procedure into the surgery resident training programs.
When the faculty were learning the procedures, residents initially participated
as assistants but gradually laparoscopic cholecystectomy was incorporated
into residency training. Today, the old paradigm of see-one, do-one, teach
one has been replaced with curricula to teach basic laparoscopic techniques
and gradual introduction of the newer procedures into fellowships and surgical residency. Fundamentals of laparoscopic surgery (FLS) is a program
developed by SAGES and designed to teach and evaluate the knowledge,
judgment, and skills fundamental to laparoscopic surgery, independent of
the surgical specialty. Through rigorous evaluation, the program has been
demonstrated a reliable and valid means of developing prociency in laparoscopic surgery [9]. The manual skills component is based on that developed at
McGill University [10]. Many surgery training programs have incorporated
FLS or other structured skills training curricula into the residency [11].
Before laparoscopic cholecystectomy, there was little if any mention of
surgical simulation in the surgical literature. In many areas of surgery and
endoscopy, industry has developed procedure simulation. These have
proved valuable adjuncts in training. Recently, however, some authorities
have indicated that until the predictive value of simulated testing has been
validated further, competence still needs to be determined by expert assessment of observed performance in real cases by measurable outcomes in real
procedures [12]. There is no substitute for experience. Hence, the evolution
of minimally invasive surgery also has been accompanied the development
of procedure-based fellowships.
932
Frequency of Cases
Attending
Fellow
Resident
30
20
10
0
0
12
18
24
30
36
Months
Fig. 2. The learning process of a new procedure. At rst the attending surgeons perform the
case, followed by fellows and then residents. It may take 18 to 24 months for new procedures
to be fully incorporated into residency training programs.
933
934
gastric bypass 100 cases [17,18]. This does not include factoring in transference of skill of one procedure to another, practice in simulators, and cumulative skill development from other procedures. For example, some
procedures are built on basic steps involved with other procedures, such
as trocar placement, suturing, use of staplers, and so forth. Also these
estimates do not consider individual capabilities. Unfortunately, there is
an overall lack of consensus on how many procedures need to be performed
to be eligible for the initial awarding of privileges for a procedure or to
maintain those privileges. With increasing general laparoscopic experience,
it is likely that the asymptote of the learning curve will be reached with fewer
cases. Thus, there is no simple formula for credentialing new procedures.
It is up to individual hospital credentials committees to decide the threshold
of necessary experience to ensure safe and quality patient care and to award
privileges.
Ethical considerations in the introduction of new technology
Laparoscopy has stimulated interest in the ethics of new procedure application. In this area there likely are more questions than answers and lessons.
Iserson and Chiasson state, Medical technology itself, including minimally
invasive surgery has no morals: our morality revolves around when and how
we use the technology [19]. The primary ethical consideration involving
application of new technologies in medicine and surgery over which physicians have control is that of provider prociency with the procedure or
device, information they provide to patients about the risks and benets
of the procedure and alternative treatments. One could argue that such disclosure should include the number of times the new procedure has been
performed by a provider or the number of times a new device has been
used and what the outcomes have been. As indicated in the previous discussion, the learning curve for new procedures is variable depending on the
complexity of an operation, patient factors, the disease process, equipment,
and the surgeon skill and judgment.
There are many questions around the process for introduction of new
technology. When do providers know they are ready to perform a new procedure without supervision? As discussed previously, surgeons tend to overrate their performance in laparoscopic training programs. Therefore,
standard performance metrics, such as FLS, are essential and need to be
developed for more complex tasks. Who will determine that surgeons can
perform a new procedure safely? In a surgery resident training program,
this is determined by assessment by the faculty and the number of cases performed. Ideally, for a practitioner learning a new procedure, a third party
should preceptor the individual and verify prociency. But how many cases
are sucient to know that providers have developed sucient skill to know
that they can perform a procedure independently. How does a single preceptor know that a surgeon is ready to do a procedure independently? Is the
935
936
typical patients, and (3) the CPT code generally used for a service or procedure does not represent the technical diculty or physician work when dealing with a specic population (eg, neonates).
The process to request a new CPT code is outlined in Fig. 3. Once the
necessary information is received, the AMA sta reviews the request;
then, it is reviewed by the by CPT specialty advisors and then the CPT
panel. If a new or revised CPT code is issued, it is referred to the AMA/
Specialty Society Relative Value Scale Update Committee for determination
of the new codes value for reimbursement.
CPT Panel
Table Proposal
Reject Proposal
New or Revised
CPT Code
AMA RUC
937
6
5
4
3
2
1
0
1990
1992
1994
1996
1998
2000
Year
Lap Chole
Introduced
Fig. 4. Length of stay of patients undergoing open cholecystectomy decreased after the experience with laparoscopic cholecystectomy.
938
measurement of hepatic mRNA levels of beta-brinogen, alpha-1chymotrypsin inhibitor, metallothionein, heat shock protein, and polyubiquitin. No dierences were found between open and laparoscopic
procedures.
The inammatory response to laparoscopic surgery also is dampened.
The peripheral leukocyte function may be better preserved after laparoscopic cholecystectomy in comparison to open cholecystectomy. Elevations
of polymorphonuclear cells (PMN)-elastase and C-reactive protein are biomarkers for the inammatory response. Elevations are less after laparoscopic compared with open cholecystectomy [31]. The dampened systemic
response may be related to carbon dioxide insuation during laparoscopy
rather than the less traumatic nature of the procedure. Theoretically, this
may be related to a suppression of peritoneal macrophage functions induced
by carbon dioxide. In vivo data suggest that carbon dioxide also can aect
neutrophils (polymorphonuclear cells), the most abundant cell type in the
inamed peritoneal cavity. Shimotakahara and colleagues [32] demonstrated
that carbon dioxide incubation directly and temporarily suppressed the
proinammatory functions of polymorphonuclear cells. This eect could
contribute to the dampened inammatory response to laparoscopic surgery.
It also raises the question of whether or not the temporary suppression of
neutrophil functions could aect the clearance of bacterial contaminations.
The logical extension of the studies (discussed previously) was to investigate the impact of traditional open methods and minimally invasive techniques on a variety of immune function parameters. Major surgery results
in period of cell-mediated immunosuppression that can aect patient recovery negatively. Carter and Whelan [33] reviewed the topic and found that
studies uniformly show that open methods result in signicantly more immunosuppression than laparoscopic techniques. It seems that the choice
of surgical approach does not have an impact on the absolute number of
lymphocytes or lymphocyte subpopulations but is associated with suppressed
lymphocyte function. Laparotomy seems to result in greater decreases in
monocyte-mediated cytotoxicity while at the same time activating monocytes
to elaborate more tumor necrosis factor a and superoxide anion than laparoscopic methods. Studies on natural killer cell counts and function are conicting and no denitive conclusions can be established. As indicated previously,
the majority of the data suggest that open surgery is associated with signicantly higher levels of interleukin 6 and C-reactive protein.
Minimally invasive methods are less stressful, as judged by these parameters. It seems that one way to avoid or minimize immunosuppression after
surgery is to use minimally invasive methods. In theory, laparoscopic cancer
resection methods may be associated with less cancer progression. A case in
point is the study of Shiromizu and colleagues [34], which showed that
laparotomy accelerated pulmonary tumor metastases whereas laparoscopy
did not increase the frequency or growth of lung metastases. There is no
human evidence to support this hypothesis. Minimally invasive methods
939
may be associated with oncologic advantages that go well beyond less pain,
a quicker recovery, and a shorter length of stay. More basic science and
human studies are needed on this intriguing topic.
Postoperative gastrointestinal function
% Nasogastric Tube
1992
1994
1996
1998
2000
Year
Fig. 5. Frequency of nasogastric tube use after colon and rectal surgery.
940
vomiting, possibly leading to aspiration, anastomotic leaks, or wound dehiscence. The shorter stays after minimally invasive gastrointestinal surgery
forced early resumption of oral intake and challenged the traditional paradigm. Reissman and colleagues [40] reported a prospective randomized trial
of initiation of oral intake on postoperative day 1 after elective colon and
rectal surgery in 161 patients. There was no dierence in complications or
length of stay although the early group had quicker return of bowel function
and tolerated a regular diet signicantly earlier than the group treated in the
traditional manner. A meta-analysis in 2007 reported no signicant dierence in postoperative ileus, vomiting, abdominal distension, time to passage
of atus, wound complications, and pneumonia with early oral intake [41].
Summary
The evolution of the laparoscopic and minimally invasive surgical revolution has taught many lessons that have had an impact on the way physicians are trained in new procedures and in caring for patients. It is likely
that the continued evolution of minimally invasive surgery will provide
additional lessons that will challenge traditional concepts and change the
way patients are cared for in the future.
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