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 Surg Clin N Am 88 (2008) xi–xiii

Foreword

Ronald F. Martin, MD
Consulting Editor

History does not crawl, it jumps.

dNassim Nicholas Taleb, Author of The Black Swan: The Impact of the
Highly Improbable.
It may not be possible to adequately assess the impact of minimally inva-
sive surgical (MIS) procedures on the practice and discipline of surgery. One
could start nearly anyplace to begin a discussion about how the expansion
of videoscopic procedures has changed our practice and go on to develop
an entire book of thoughts. But the idea that led to the beginning concept
for this issue was, how do we know when something is working out the
way we had intended or, at least, hoped for? During discussions, we began
to formulate a series of topics to look at advances and controversies in MIS
development. Interestingly, many of the people with whom I spoke felt that
there were no controversies and that we would probably perform every pro-
cedure with videoscopic assistance somedaydperhaps all by NOTES (natu-
ral orifice translumenal endoscopic surgery) at some point. An outflow of
those discussions set the stage for this series of articles that Drs. Gould
and Melvin have been kind enough to edit.
Probably the first controversy that should leap to mind regarding MIS pro-
cedures is the mechanism by which new technology is introduced to the public.
As is well illustrated by Drs. Ellison and Carey in their article in this issue,
the introduction of laparoscopic cholecystectomy was a ‘‘revolutionary’’ in-
troduction, not borne out of development after careful development and in-
vestigation in academic centers, but arising from community hospitals and

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xii FOREWORD

delivered directly to an eager public. After an initial rebuff from the estab-
lished academic centers and concurrent rapid market shift of patients to
community institutions offering this new procedure, the academic halls scram-
bled quickly (and some might add desperately) to develop their own MIS
capacity. Since that time it seems that many are extremely reluctant to risk de-
lay in embracing new proceduresdregardless of their level of developmentd
for fear of getting behind the curve so badly again.
The next, and logically necessary, controversy was who was going to de-
fine standards and competencies for MIS procedures. Some might argue
that the original pioneers (who by the way had no real oversight during their
developmental phase) would be the logical choice to train the next adoptive
generation; others argued that the usual large societies and national organiza-
tions should place these procedures under their ‘‘umbrella’’ of responsibility.
It is hard to say whether this initially constituted an environment of ‘‘pulling
up the ladder once one is in the life raft’’ for the pioneers or furthered monop-
olistic control of ‘‘certifying’’ organizations but, thankfully, the resulting pro-
cess as endorsed by the American College of Surgeons and other large
national and international professional societies have created guidelines that
seem reasonable, fair, and beneficial. This may also reflect that the pioneers,
or at least the very early generation of followers, were quickly accepted into
leadership positions within many of the large established societies, and this
new breed of surgeons formed new societies which grew rapidly and became
influential as well.
The desire for hospitals and physicians to maintain or expand their posi-
tions in a new competitive marketplace drove the need for rapid training of
surgeons in these techniques and use of instruments. The creation of these
largely technique-based fellowships to create ‘‘technical experts’’ (as op-
posed to ‘‘disease-based experts’’) in all organ systems has generated yet an-
other controversy. There has been a marked expansion in the number of
programs and number of positions in MIS fellowships. In my opinion, this
has been short-sighted. One thing that we should have learned from the de-
velopment of MIS techniques is that any operation can potentially be ac-
complished by MIS instrumentation and techniques. As we reach a new
level of equilibrium and distribution of MIS technology, it may be time to
reconsider that MIS training should return in part or whole to sub-specialty
fellowships and general surgery residency training as an expectation of com-
petency and proficiency, as opposed to an ‘‘additional’’ skill set. It does not
appear that MIS knowledge is optional in any surgical specialty any longer.
The last controversy that I would like to address is that the perceived
benefit of videoscopic surgery over open procedures may not be due com-
pletely to the newer techniques actually being superior. We may have
learned as much about the dogmatic and somewhat errant practice in open
surgery as we did about MIS. We certainly learned that one can discharge
patients sooner than we thought after many operations, we can feed people
sooner after many procedures, and we can use different fastening devices
 FOREWORD xiii

than we were used to using. These realizations do not diminish the value of
MIS procedures but they do illustrate how far off the mark we were in some
of most clung-to assumptions about surgery in the open era.
The last two decades or so have largely allowed us to push the envelope
on what we can do with MIS. I would submit we have done a far poorer job
of defining what we should do with MIS. There are still many of us who re-
member the frenzy of trying to recover position after initially scoffing at peo-
ple (not even thought of as surgeons) who ‘‘operated through keyholes with
chopsticks,’’ as one mentor of mine used to put it. And those who remember
those days vividly recall how absolutely wrong those unfounded disbeliefs
were. Yet, we remain in a position where it should be incumbent upon us
all to define what problem we are solving and whether or not adopting
new technology is something that truly benefits the patient medically and
helps the system to remain fiscally sustainable.
The presence of MIS procedures is and should remain an important part
of our practice, as will the development and improvement of these tech-
niques. As surgical history continues to be written, there will inevitably
be another jump in our future. In the meantime, we shall have to crawl
along with these changes until that new paradigm shift occurs. These excel-
lent articles will hopefully give the reader an opportunity to become better
versed in what is possible and what is advisable. I am deeply indebted to
Drs. Gould and Melvin, along with their co-contributors, for their excellent
effort.

Ronald F. Martin, MD
Department of Surgery
Marshfield Clinic
1000 North Oak Avenue
Marshfield, WI 54449, USA
E-mail address: martin.ronald@marshfieldclinic.org
 Surg Clin N Am 88 (2008) xv–xvi

Preface

Jon Gould, MD W. Scott Melvin, MD

Guest Editors

In the 20 years since the first laparoscopic cholecystectomy, we have

witnessed an incredible paradigm shift in the surgical treatment of disease.
Within 3 short years, laparoscopic cholecystectomy has become common-
place and the preferred approach. Through the ‘‘evolution of the laparo-
scopic revolution’’ (discussed in the article by Ellison), we have learned
many lessons as a result of this experience. The laparoscopic revolution
has occurred during a time of tremendous and rapid technologic progress.
At the time of the first cholecystectomy, no one had heard of the Internet,
cell phones were the size of a brick, and instruments for advanced laparos-
copy simply did not exist. Today, robotic technology can enable a surgeon
to remove the gallbladder from a patient across the ocean. Gallbladders can
be extracted from a patient’s mouth with virtually no scars (see the article by
Melvin). We may not be far from a day when miniature surgical robots can
be deployed into the peritoneal cavity to facilitate or even perform surgery
through a natural orifice (as presented in the article by Oleynikov). Antire-
flux surgery has evolved from open, to laparoscopic, and now to endoscopic
and endoluminal therapy (as discussed in the article by Smith).
In this modern era of health care, and looking into the future, we will be
forced to consider how far to ride this ‘‘tidal wave’’ of technology and prog-
ress. Is it reasonable to violate a vital organ to take out a gallbladder in
order to avoid three to four tiny scars? At what cost? At what morbidity?
Who should be doing these procedures: surgeons or gastroenterologists?
Who should pay for them? Can we as a society afford to pay for this kind

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xvi PREFACE

of technology? Is a robotic Nissen fundoplication really better than a laparo-

scopic Nissen fundoplication? Is a laparoscopic hernia repair really better
than an open hernia repair? The last 20 years of progress in minimally inva-
sive surgery have created as many unanswered questions and dilemmas as
have been solved. One thing is for certain: compared to today, the face of
General Surgery is likely to look as different in 2028 as it did back in
1988, when that first gallbladder was squeezed out of a tiny laparoscopic
port site.

Jon Gould, MD
University of Wisconsin School of Medicine and Public Health
Department of Surgery
H4/726 Clinical Science Center
600 Highland Avenue
Madison, WI 53792, USA
E-mail address: [email protected]

W. Scott Melvin, MD
Department of Surgery
Center for Minimally Invasive Surgery
Division of General Surgery
The Ohio State University School of Medicine and Public Health
N729 Doan Hall
410 West 10th Avenue
Columbus, OH 43210, USA
E-mail address: [email protected]
 Surg Clin N Am 88 (2008) 927–941

Lessons Learned from the Evolution

of the Laparoscopic Revolution
E. Christopher Ellison, MDa,*, Larry C. Carey, MDb
a
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

Introduction of new technology

Evolution versus revolution
Advances in new technology and medications in medicine occur in two
ways: evolutionary or revolutionary. The majority of time they are evolu-
tionary, based on discovery and incremental innovation in the scientific
community and the academic medical centers. In these instances, there is
time to respond with prospective analysis to determine the safety and
efficacy of new treatments and to provide appropriate education beginning
initially in university medical centers and then with gradual introduction
into the medical community through continuing medical education. An
example of surgical evolutionary change is cardiopulmonary bypass or the
introduction of surgical staplers. Not so with the introduction of laparo-
scopic cholecystectomy. This was a revolutionary change; there would be
no time for the orderly introduction. When first introduced, there was
a rush for practicing surgeons to acquire this new technique and incorporate
it into their practice. This resulted from the clear advantages that the tech-
nique provided patients in terms of reduced abdominal wall scarring, hospi-
talization, and time off work [1]. It also was driven by economics of surgical
practice. Early on it became readily apparent to the public through media
coverage, including television, radio, printed material, and even billboards,
that there was a new technique for gall bladder removal. Patients needing
gall bladder surgery and their referring physicians asked for ‘‘laser cholecys-
tectomy.’’ This name became attached to the procedure because at the time

* Corresponding author.
E-mail address: [email protected] (E.C. Ellison).

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928 ELLISON & CAREY

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 fiscal 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 pro-
vide courses for training surgeons and their operative teams. There was no
organized effort to credential and codify these training programs; the pro-
cess simply did not exist. Some of these courses were good, including didac-
tic, 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 certificate of attendance but usu-
ally not proficiency and the course did not certify competence. Surgeons
usually ascertained their own proficiency. Studies have shown that students
may overestimate their performance and skill level during laparoscopic
training courses [2]. In addition, hospitals had limited guidelines for creden-
tialing. 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 first few
cases, but there were no established guidelines or recommendations for pre-
ceptoring 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 laparo-
scopic 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 lap-
aroscopic cholecystectomy [3]. The guidelines recognized that the procedure
was effective and safe but that it required training in animal models and that
the first 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
 LESSONS LEARNED FROM EVOLUTION OF LAPAROSCOPIC 929

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.

Box 1. American College of Surgeons guidelines for evaluation

of credentials of individuals for the purpose of awarding surgical
privileges in new technologies
1. The surgeon must be a member in good standing of the
department or service from which privileges are to be
recommended.
2. A defined educational program in the technology, including
didactic and practical elements, must be completed and
documented either as a postresidency course of instruction or
as a component of an approved residency program.
3. The surgeon must be qualified, experienced, and
knowledgeable in the management of the diseases for which
the technology is applieddfor example, laparoscopic
instrumentation would be applied by surgeons who have
abdominal or pelvic surgical experience and credentials.
4. The qualifications of the surgeon to apply the new technology
must be assessed by a surgeon who is qualified and
experienced in the technology and should result in a written
recommendation to the department or service head. In the
case of a resident trained in the technology during residency,
recommendation by the program director is acceptable.
5. Maintenance of skills should be documented through periodic
outcomes assessment and evaluation in association with the
regular renewal of surgical privileges.

From American College of Surgeons Statements on emerging surgical tech-

nologies and the evaluation of credentials. Bull Am Coll Surg 1994;79(6):40–1;
with permission.
930 ELLISON & CAREY

a statement on issues to be considered before a new surgical technology is

applied to the care of patients [6]. This statement considered four fundamen-
tal issues:

1. Has the new technology been adequately tested for safety and efficacy?
2. Is the new technology at least as safe and effective as existing, proved
techniques?
3. Is the individual proposing to perform the new procedure fully qualified
to do so?
4. Is the new technology cost effective?
At its February 1998 meeting, the Board of Regents of the ACS approved
a process by which its fellows and associate fellows could be verified for use of
emerging technologies. This process was designed to provide surgeons with
documentation of educational achievement sufficient to persuade those who
are responsible for credentialing/privileging in the local practice setting that
the surgeons can be permitted to apply the technology to patients. This was
published in 1998 [7]. After the experience with laparoscopic cholecystectomy,
the ACS became a leader in establishing guidelines for other new procedures.
Additional examples of the effective educational policies and programs are the
joint statement of the ACS and the American College of Radiology on physi-
cian qualifications for the performance of stereotactic biopsy (1998) and the
development of a curriculum and training program in ultrasonography.
In addition, the ACS currently accredits Education Institutes. The defini-
tion and goals of these Educational Institutes is outlined in the following
quotation from The American College of Surgeons Web site.
The goal of the ACS Accredited Education Institutes is to focus on compe-
tencies and to specifically address the teaching, learning, and assessment of
technical skills using state-of-the-art educational methods and cutting-edge
technology. All phases of learning (before a course, during a course, and after
a course) are addressed by the faculty at the Education Institutes. Leading-
edge educational approaches will be used to ensure achievement of compe-
tence and development of expertise. The Education Institutes may use
a variety of methods to achieve specific educational outcomes, including
the use of bench models, simulations, simulators, and virtual reality. The fac-
ulty at these institutes will ensure that the participants achieve predetermined
levels of skill at the completion of the course. Opportunities for post-course
proctoring will be explored, to facilitate transfer of the newly acquired skill to
surgical practice. Also, collaborative education research would be pursued
by the Education Institutes under the aegis of the College, to advance the
science of acquisition and maintenance of surgical competence [8].
These Educational Institutes will, in part, develop a network of advanced
training sites for new surgical techniques in the future.
An additional impact of laparoscopic surgery was the development of part-
nerships between industry and medical institutions. Many academic centers
have developed relationships with industry to provide high-quality educational
 LESSONS LEARNED FROM EVOLUTION OF LAPAROSCOPIC 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 effec-
tively 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 resec-
tions, splenectomy, and adrenalectomy. The bad experience with the intro-
duction of laparoscopic cholecystectomy was not repeated because of the
efforts of organized surgery, industry, and the surgical profession. The speed
of development and widespread acceptance of these more complex proce-
dures 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 surgi-
cal 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 proficiency in laparo-
scopic 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 assess-
ment 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 ELLISON & CAREY

The focus of these fellowships is to provide in-depth training in advanced

minimally invasive procedures. Currently there are approximately 127 mini-
mally invasive surgery fellowships accredited by the Fellowship Council.
The Fellowship Council is an oversight body with representatives from several
specialty societies created to accredit fellowships in minimally invasive sur-
gery. In 2007, there were 173 positions available and 202 applicants completed
the match process (Adrian Park, MD, FACS, personal communication, 2007).
In Fig. 2, a hypothetical illustration of the performance of a new surgical
procedure by attending surgeons, fellows, and residents is depicted. Early in
the introduction of a new technique, the procedure is done by an attending sur-
geon, perhaps with another attending surgeon assisting. Then the procedure is
introduced to fellows or advanced trainees and finally surgical residents learn
the procedure. Supervised laparoscopic cholecystectomy performed by surgi-
cal trainees has a complication rate not statistically different from that of the
procedure performed by attending surgeons. In addition, the operative time
was not different. In one study, the operative time was 57 minutes for trainees
and 49 minutes for attending surgeons [13]. Resident case log experience sup-
ports the premise that advanced laparoscopic procedures are being introduced
in residency programs. The number of complex laparoscopic procedures per-
formed by residents is increasing as attending staff gain greater confidence in
these techniques and residents gain greater skills in minimally invasive surgery
through well-defined curricula and simulation.

Proficiency
How is proficiency in surgical procedures determined? Historically this
has been based on repeated observation of trainees performing a surgical
procedure by an experienced faculty member. It is an overall global assess-
ment of trainees based on their understanding of the indications and reasons
for surgery, the surgical anatomy, the steps of the procedure, the ability to
gain exposure, tissue handling, creative problem solving, and outcome. FLS
has been demonstrated to be accurate in assessing proficiency in basic

60
Frequency of Cases

50
40 Attending
30 Fellow
20 Resident

10
0
0 6 12 18 24 30 36
Months

Fig. 2. The learning process of a new procedure. At first 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.
 LESSONS LEARNED FROM EVOLUTION OF LAPAROSCOPIC 933

laparoscopic skills. Establishing proficiency in an entire operative procedure

with multiple manual steps and various levels of decision making is a differ-
ent story.
One of the lessons learned from laparoscopy involves the concept of the
learning curve. Before 1990 there were few references to the learning curve
in surgery. As noted by Subramonian and Muir [14] T.P. Wright introduced
the concept of a learning curve in aircraft manufacturing in 1936. He described
a basic theory for defining the repetitive process of aircraft assembly. The term
was introduced to medicine after the advent of minimal access surgery. Yet
there is no standardization of what the term means. The learning curve likely
is different for each surgeon and each procedure.
For the Wright learning curve, the underlying hypothesis is that the direct
person-hours necessary to complete a unit of production decrease by a con-
stant percentage each time the production quantity is doubled. In
manufacturing, the learning curve applies to the time and cost of produc-
tion. Can a surgeon’s learning curve be described on similar lines? It prob-
ably is not that simple. The variability introduced by the human factor,
patient comorbidity, and disease make simple construction of a learning
curve unlikely. It has been proposed that there are two definitions of the
learning curve for a surgical procedure: (1) the time taken or the number
of procedures an average surgeon needs to be able to perform a procedure
independently with a reasonable outcome and (2) the graphic representation
of the relationship between experience with a new procedure or technique
and outcomes, including operative time, complication rate, hospital stay,
and mortality. The former is less objective and depends on defining an
average surgeon and a reasonable outcome. Education theorists agree the
learning process is cumulative, that is, the effects of experience carry over
to aid later performance. There are three main features of a learning curve:
(1) the initial or starting point, which defines where the performance of an
individual surgeon begins; (2) the rate of learning, which measures how
quickly a surgeon reaches a certain level of performance; and (3) the plateau
point at which a surgeon’s performance stabilizes. The implications for
training in laparoscopic procedures are twofold: (1) practice helps improve
performance but the most dramatic improvement happens in the first expe-
riences with a procedure and (2) with sufficient practice surgeons can achieve
comparable levels of performance.
The way learning curves are calculated is complex and validity is difficult
to establish [15]. In minimally invasive surgery, the number of procedures
required to reach the summit of the learning curve and achieve proficiency
varies based on the type of procedure. The volume of cases for laparoscopic
cholecystectomy proficiency is estimated at 50. This is based on the observa-
tion that 90% of bile duct injuries occur during the first 30 procedures and
the calculated risk for an injury is 1.7% on the first case and 0.17% on the
fiftieth case [16]. In contrast, that for laparoscopic Nissen fundoplication is
estimated at 20 cases, laparoscopic colon resection 50 cases, and Roux-en-Y
934 ELLISON & CAREY

gastric bypass 100 cases [17,18]. This does not include factoring in transfer-
ence of skill of one procedure to another, practice in simulators, and cumu-
lative 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 appli-
cation. 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 physi-
cians have control is that of provider proficiency with the procedure or
device, information they provide to patients about the risks and benefits
of the procedure and alternative treatments. One could argue that such dis-
closure 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 discus-
sion, 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 pro-
cedure without supervision? As discussed previously, surgeons tend to over-
rate 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 per-
formed. Ideally, for a practitioner learning a new procedure, a third party
should preceptor the individual and verify proficiency. But how many cases
are sufficient to know that providers have developed sufficient skill to know
that they can perform a procedure independently. How does a single precep-
tor know that a surgeon is ready to do a procedure independently? Is the
 LESSONS LEARNED FROM EVOLUTION OF LAPAROSCOPIC 935

preceptor willing to sign off on proficiency? Who is liable should there be

a bad outcome: the physician or the certifier of competence? How should
these assessments be incorporated into hospital credentialing and the award
of privileges? In reality, practitioner credentialing primarily controls the use
of a new technology. In the end, however, the ethics of physicians and
hospitals ultimately determine how new procedures are introduced. The
evolution of laparoscopy has taught the profession to reflect on these issues
but has provided few clear-cut answers. Continued attention to the ethical
fabric is essential.

Reimbursement for new procedures and the process for applying

for a new Current Procedural Terminology code
When laparoscopic cholecystectomy was introduced, physicians did not
know how best to interact with medical insurance companies to be reim-
bursed or the multiple steps required as a new procedure advanced from
research concept to the assignment of a code in the American Medical
Association (AMA) Current Procedural Terminology (CPT). Today, new
procedure development outpaces the development of CPT codes. When
a new procedure is introduced, there is an increased need for preauthoriza-
tion, reporting an unlisted procedure code, and ensuring that complete doc-
umentation accompanies the claim. Physicians should be proactive about
educating the insurance community where necessary about the results of
new treatments and procedures. This proved helpful in avoiding denials
for payment when laparoscopic cholecystectomy was introduced.
The process for applying for a new CPT code is outlined on the AMA
Web site [20]. There are several questions that should be considered before
submitting requests for new CPT codes or changes to existing codes:
1. Is the suggestion a fragmentation or variation of an existing procedure
or service?
2. Can the suggested procedure or service be reported by using two or
more existing codes?
3. Does the suggested procedure or service represent a distinct service?
4. Is the suggested procedure or service merely a means to report extraor-
dinary circumstances related to the performance of a procedure or
service already in CPT?
5. Is this a new procedure or technology?
If the answer to these questions supports a new procedure code, then the
requesting physician should contact the appropriate specialty society or
the ACS to initiate the process. The best reasons for new codes are
(1) new clinical service or technical procedure not found in the current
version of CPT (CPT [R]) and not sufficiently represented or reported
with existing CPT codes; (2) change of an existing service or procedure
when the existing CPT code no longer adequately describes the services or
936 ELLISON & CAREY

typical patients, and (3) the CPT code generally used for a service or proce-
dure does not represent the technical difficulty or physician work when deal-
ing with a specific population (eg, neonates).
The process to request a new CPT code is outlined in Fig. 3. Once the
necessary information is received, the AMA staff 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.

Medical lessons learned from laparoscopy

Length of hospitalization
The rapid recovery of patients having laparoscopic cholecystectomy
intrigued surgeons and initiated a review of practices with open cholecystec-
tomy. Fast tracking open procedures was reported. In a prospective study in
1991, 500 consecutive patients who had open cholecystectomy were found to
have had a mean length of stay of 1.9 days. One fourth of the total group
was discharged within 24 hours and more than half within 48 hours [21].
Moss [21] reported 158 of 160 consecutive patients who had open cholecys-
tectomy discharged the day after surgery after a specific protocol and con-
cluded that the shorter length of stay after cholecystectomy primarily may
reflect the altered expectations that were derived form the introduction of
laparoscopic cholecystectomy. Other studies also reported that conversion
of a laparoscopic cholecystectomy resulted in minimal increases in hospital-
ization [22]. A review of length of stay of elective open cholecystectomy at
The Ohio State University showed a similar trend to shortened length of
stay (Fig. 4).

ACS or Specialty Society

AMA Staff Review

CPT Specialty Advisors

CPT Panel

New or Revised
Table Proposal
CPT Code

Reject Proposal
AMA RUC

Fig. 3. Process to request a new CPT code.

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