Surgical Clinics of North America
Volume 76 • Number 3 • June 1996
Copyright © 1996 W. B. Saunders Company
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LAPAROSCOPIC SURGERY
TRAINING AND PRIVILEGING FOR NEW PROCEDURES
Thomas L. Dent MD
From the Department of Surgery, Abington Memorial Hospital, Abington, Pennsylvania
The privileging process is intended to ensure that patients receive skillful care by competent practitioners.
Privileges are those clinical functions that a health care institution permits a physician to perform while
caring for patients in that institution. The responsibility for the granting of clinical privileges currently
belongs to each individual hospital's governing board, [12] although there has been some discussion about
"portable privileges" that might be granted by national surgical organizations, such as the American College
of Surgeons. [8] Hospitals must develop criteria and mechanisms for granting clinical privileges. For practical
reasons, most adopt criteria published by specialty boards or specialty societies. The department or the
hospital also should develop a privilege list of specific operative procedures within each specialty that should
be re-evaluated and updated on a regular basis as new procedures are developed and as some existing
procedures become obsolete.
Address reprint requests to
Thomas L. Dent, MD
Department of Surgery
Abington Memorial Hospital
Abington, PA 19001
THE PRIVILEGING PROCESS
The hospital credentials committee or the chief of the appropriate clinical service evaluates the initial request for
overall clinical privileges by reviewing the physician's credentials: board certification; training and experience; and
certification of competence by the residency program director, instructors, and/or peers. Some hospitals grant
clinical privileges provisionally and/or require that physicians be proctored for a period of time before full privileges
are granted, whereas others do not.
If additional privileges in an established procedure already listed among the hospital's specialty privileges are
desired, the applicant must demonstrate adequate education, training, experience, and competence in the procedure.
Some hospitals have established minimum supervised numbers of new procedures,
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whereas others require a period of proctoring and certification of competence by the proctor before granting the
privileges.
ADDITIONAL PRIVILEGES FOR NEW PROCEDURES
Medical and surgical breakthroughs are increasing exponentially. Before establishing criteria for the granting of new
privileges, a hospital must decide if a new procedure is commonly accepted by the surgical community. If not, the
procedure should be deemed experimental or investigational, and privileges should not be granted unless it is
performed as part of a formal clinical trial. This determination is a difficult one for hospitals today, because
objective outcome data are rarely available before patients and surgeons hear enthusiastic results of a promising new
procedure. Nevertheless, the hospital, relying on necessarily imperfect information, must make this judgment.
Criteria for obtaining clinical privileges in the new procedure, which should specify the credentials required and the
method of documenting competence in the procedure, should be formulated.
Postresidency skills in the application of new nonprocedural advances (e.g., the use of new thrombolytic agents) can
usually be acquired by reading and/or attending seminars. Because they require no hands-on experience before being
incorporated into clinical practice, they rarely require additional specific privileging. Similarly, most "new" surgical
procedures are really only adaptations of standard operations (e.g., highly selective rather than truncal vagotomy)
and also do not require additional privileges because the same instrumentation is used. The additional skills to
perform them can be acquired simply by reading about the technique, practicing on inanimate materials, and
watching the procedure being performed. However, if the basic skills involved were not part of the surgeon's
residency training, listening to a lecture or viewing a videotape is not sufficient to acquire the ability to perform a
completely new surgical procedure safely.
Basic and advanced laparoscopic procedures use technology and instruments unfamiliar to the practicing surgeon
who finished residency training prior to 1990 and are associated with major morbidity and mortality. Most experts
agree that, if laparoscopic surgery was not included in one's residency curriculum, the acquisition of these skills
requires additional formal training. [1] [10] [11] [15] [19] [22] [27]
SURGICAL EDUCATION
Residency education in the United States is the most rigorous in the world. Each surgical specialty board has
specific requirements concerning the amount and content of educational exposure to the specialty and the type of
supervised operative experience necessary before an applicant is eligible to sit for board examination in that
specialty. Therefore, board certification of a surgeon offers reasonable assurance that he or she is competent to
perform the procedures included in that specialty's procedure list at the time of board certification.
Postresidency surgical education, unfortunately, is not well organized or structured. It is difficult for a surgeon
already in practice to obtain adequate hands-on training for procedures not learned during his or her residency.
There currently are no nationally or regionally organized postresidency laboratories or training programs where
general surgeons can master technical skills. Residency
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programs do not have the case material to provide adequate postresidency experience, even for their own graduates.
Many specialty societies provide postgraduate seminars and lectures, but none is able to supply the kind of
supervised hands-on operative experience that is provided in a surgical residency program and is necessary to learn a
truly new procedure. Instrument manufacturers and surgeon-entrepreneurs currently offer weekend courses that have
not been subjected to the same educational supervision as residency programs. [10] Training in advanced laparoscopic
surgery is expensive and time-consuming, and hands-on experience in adequate volume outside of a fellowship
experience is virtually impossible to acquire. There has been some preliminary discussion about providing formal
postgraduate hands-on operative experience in new procedures. Specifically, the American College of Surgeons [2]
(ACS) is discussing the development of operative laboratories and surgical simulators; the Society of American
Gastrointestinal Endoscopic Surgeons [19] (SAGES) has published a list of available preceptors and is considering
organizing and accrediting laparoscopic fellowships (analogous to those accredited by the Society of Surgical
Oncology).
THE LEARNING CURVE
A learning curve, the term used to describe the observation that the technical complication rate of a new procedure is
higher early in a surgeon's learning experience before a plateau of competency is reached, is inherent to any
operative learning situation and is the primary reason that surgical residencies exist. [5] There have been many
anecdotal reports of complications and higher conversion rates of laparoscopic cholecystectomy occurring more
frequently early in a surgeon's experience. [3] [14] A recent study of 8839 laparoscopic cholecystectomies and 15 bile
duct injuries has defined the learning curve for this procedure by demonstrating that 90% of these serious injuries
occurred within the first 30 cases performed by an individual surgeon. [20] There have been no good studies defining
the learning curve for advanced laparoscopic procedures, but it is logical to assume that it will be similar, possibly
shortened by prior experience in basic laparoscopy but also probably lengthened by the increased degree of
difficulty of these procedures.
Adequate education and training in laparoscopic surgery are essential to minimize the learning curve. A Japanese
study demonstrated that major complications following laparoscopic cholecystectomy were three times more
common when the initial training period consisted of only two supervised operations rather than 10. [26] A study of
laparoscopic urologic surgery showed that urologists who attended only an introductory training course had
significantly more complications than those who obtained additional training before beginning to perform these
operations. [17] Others, including our hospital, have insisted that surgeons incorporating laparoscopy into their
practice be supervised or proctored during the initial learning period. [7] [9] [18] [20] [27] We also have found it helpful
for two or three surgeons to assist each other until the learning curve for each procedure is passed so that all would
learn from the early cases and complications would be minimized.
Rather than developing training and privileging guidelines for every possible laparoscopic procedure, it seems
prudent to separate laparoscopy into two categories: basic and advanced. [6] Basic laparoscopic procedures are those
that require simple dissection or excisional techniques that can be accomplished with the use of scissors, clips,
electrocautery, and staplers, whereas advanced
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laparoscopic procedures involve more complex surgical maneuvers and require a mastery of specialized tools.
BASIC LAPAROSCOPY
Basic laparoscopic general surgical procedures include diagnostic laparoscopy, lysis of adhesions, cholecystectomy,
appendectomy, and inguinal herniorrhaphy. Basic laparoscopy is now part of the training curriculum of virtually all
surgical residency programs, [16] [23] with the average graduating general surgery resident in 1995 performing 53
laparoscopic and 30 open cholecystectomies during 5 years of training. Almost all currently practicing general
surgeons have obtained basic laparoscopy training, and 80% of cholecystectomies now are performed
laparoscopically. [21] Therefore, training and privileging for basic laparoscopy are no longer major issues.
ADVANCED LAPAROSCOPY
Advanced laparoscopic surgery requires mastery of intracorporeal and extracorporeal knot-tying and suturing, which
are more difficult than and very different from those used in open operations as well as in basic laparoscopy.
Currently, laparoscopic common bile duct exploration, vagotomy, bowel resection, gastric fundoplication, and
splenectomy are the most frequently performed advanced procedures.
Adequate training in advanced laparoscopy is not currently being provided in surgical residency programs, nor have
most practicing surgeons been trained in it, a situation reminiscent of basic laparoscopy 5 years ago. An additional
complicating factor is that the open counterparts of these procedures are performed much less frequently than
cholecystectomy, impeding trainees from moving beyond the learning curve to proficiency. There are, of course,
skills common to all of these advanced procedures that reduce the number of each individual procedure that one
must perform to become technically competent, but even considering them as one group, the volume of advanced
laparoscopic procedures is still quite low. Additionally, the complications resulting from technical errors during the
learning curve of advanced laparoscopic surgery (e.g., pneumothorax, massive hemorrhage, gastrointestinal
perforation, and bile leakage) are arguably more frequent and serious than those resulting from basic laparoscopic
procedures. [4] [24] [25]
Privileging criteria for advanced laparoscopic procedures first must include prior privileges and experience in
comparable open procedures [2] and current competence and privileges in basic laparoscopic techniques, followed by
additional didactic and hands-on training in advanced laparoscopic techniques. Although animal laboratories can
provide the initial technical experience, supervised hands-on experience in humans is essential, in this author's
opinion. This training might be obtained by a preceptorship at one's own hospital, either by bringing in an outside
expert or by having a local surgeon already privileged in advanced procedures act as the preceptor (obviously not an
option if no one at the hospital has yet become privileged). However, because of the difficulties in obtaining
adequate numbers of supervised cases, spending a significant period of time away at a preceptorship or taking a full
year's fellowship is probably the ideal way of obtaining the necessary training.
At our community teaching hospital, several surgeons, each of whom had
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already performed hundreds of basic laparoscopic procedures and had completed an advanced laparoscopic course
that used animate models, visited laparoscopic centers to observe these advanced procedures. This learning
experience was not hands-on, and we believed that it was inadequate preparation for advanced laparoscopy. We next
considered two ways of developing advanced laparoscopic surgery in our hospital: identify a current attending
surgeon to lead the advanced laparoscopic effort, obtain the extended training necessary, and, once proficient, have
him or her return to assist others in developing their advanced laparoscopic skills; or bring in an outside preceptor to
assist and teach us. Unfortunately, no surgeon could leave his or her practice long enough to attend a formal
fellowship, and our preliminary attempts to bring in outside preceptors were prohibitively expensive and inefficient.
Our solution was the return of one of our graduates who completed a formal 12-month advanced laparoscopic
fellowship. He will assist other surgeons (even competitors) at our hospital in developing advanced laparoscopic
skills and in their becoming privileged.
EXPERIMENTAL PROCEDURES
For an operation to be experimental, it must be radically new, or at least different from alternative procedures, either
in technique or design. Few advanced laparoscopic procedures are truly experimental. The techniques (e.g.,
electrocoagulation, stapling, suturing) and design (e.g., colectomy, splenectomy) used for most laparoscopic
operations are very similar to their open counterparts, except for the method of access to the abdominal cavity.
These new procedures can be accepted by the surgical community once procedural safety (mortality and morbidity)
has been established. Surgeons privileged in advanced laparoscopic surgery can then decide whether or not to begin
performing the procedure prior to a definitive conclusion being published regarding its effectiveness (long-term
results, advantages over established procedures) and costs (equipment, operating room time, personnel). Once a
surgeon is privileged in advanced laparoscopy, the performance of each advanced procedure is no longer a hospital
privileging issue, but rather one of procedure effectiveness, and is best evaluated by the surgical department. For
example, reports of increased numbers of early trocar site tumor growth have caused some to recommend caution in
performing laparoscopic colectomy for colon malignancies, [25] whereas others have not seen this and believe that
laparoscopy is appropriate for colon cancer operations. It is now possible to perform laparoscopic herniorrhaphy
safely and with recurrence rates comparable to those for open repair, [13] and the fact that it requires general
anesthesia and costs more does not make it an experimental procedure. Some advanced laparoscopic procedures,
such as splenectomy and colectomy, [28] require longer operating times and more expensive equipment to perform,
but these disadvantages, again, do not render them experimental.
Scientifically establishing the effectiveness of a new procedure takes years and requires large randomized series of
patients. Some would like to see the performance of new laparoscopic surgical procedures restricted to academic
centers that "participate in current or planned prospective studies designed to optimize the technique and carefully
refine its indications" [4] until their effectiveness is firmly established. As imperfect as our system is, this author
believes that progress would be severely impeded if every logical surgical innovation, such as laparoscopic
cholecystectomy (now clearly superior to open cholecystectomy
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without a randomized trial ever being done), had to undergo extensive prospective randomized testing resulting in a
definitive conclusion as to its effectiveness prior to allowing its clinical use. It is the ethical responsibility of the
surgeon privileged to perform advanced laparoscopic procedures, with the consultation of his or her peers and the
departmental chairman, to evaluate the current literature and to decide when to offer each of these new procedures to
patients.
PERFORMANCE ASSESSMENT
The outcomes of a surgeon's performance in advanced laparoscopic surgery, as in all other surgical procedures, [12]
should be monitored as part of the hospital's performance assessment program. Proctoring, additional training, or
even restriction of privileges may be necessary if individual high complication rates or other performance problems
are identified. The surgeon also has a personal responsibility to keep abreast of new information about laparoscopic
surgery because new variations in technique and equipment are frequent in this rapidly evolving field. Periodic
reassessment of departmental mortality and morbidity, as well as outcome studies in the literature, should guide the
surgeon and the department in offering or withdrawing procedures in this rapidly evolving field of advanced
laparoscopic surgery.
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