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CREDENTIALLING FOR THE PERFORMANCE OF LAPAROSCOPY COLECTOMY FOR

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CREDENTIALLING FOR THE PERFORMANCE OF LAPAROSCOPY COLECTOMY FOR Powered By Docstoc
					    CREDENTIALLING FOR THE PERFORMANCE OF
    LAPAROSCOPIC COLECTOMY FOR BENIGN AND
              MALIGNANT DISEASE

                   Steven D. Wexner M.D., FACS, FRCS, FRCS(Ed)
             Chairman, Department of Colorectal Surgery Cleveland Clinic Florida, Weston, FL
    Professor of Surgery, Ohio State University Health Sciences Center at the Cleveland Clinic Foundation
              Clinical Professor, Department of Surgery, University of South Florida College of
                                                  Medicine


                                        Susan M. Cera, MD
                                             Clinical Associate
                                          Cleveland Clinic Florida




Objectives:

   1. Review studies analyzing the learning curve for laparoscopy for colorectal
      disease.

   2. Understand the process through which a surgeon is trained for laparoscopy for
      colorectal disease.
         Laparoscopy accounts for an estimated 40% of urology, 50% of general surgery,
and 70% of gynecologic procedures. While laparoscopy offers several advantages over
laparotomy, there has been an increase in complications and serious fatal sequelae.
Professional liability insurance carriers have seen a growing number of claims
associated with laparoscopic procedures. Literature regarding outcome of litigation has
been most commonly published with respect to laparoscopic cholecystectomy because
of the widespread adoption of this technique for over the past decade.
     In 1997, Kern reviewed 44 cases of malpractice litigation involving laparoscopic
cholecystectomy for cost, cause, and consequences of civil court actions1. The 44
injuries composed 4 main categories of injuries: (1) bile duct, n=27, 61%; (2) bowel,
n=7, 16%; (3) major vascular, n=4, 9%; and (4) other, n=6, 14%. Bowel injuries
involved trocar or cautery injury; vascular injuries all involved trocars. There were 7
deaths (16%). Of the 44 cases, 21 (48%) settled out of court (mean payment, $469 711).
Of the remaining 23 cases proceeding to trial, 19 (83%) were defended successfully
while 4 (17%) concluded with plaintiff jury verdicts (mean payment, $188 772).
Frequent settlements of cases involving laparoscopic cholecystectomy injuries that are
litigated have resulted in a selection of cases of increased defensibility at trial. The high
mortality rate from bowel injuries is a new medico legal finding in laparoscopic
cholecystectomies, as expensive to settle (mean payment, $438 000) as laparoscopic
cholecystectomy bile duct injury (mean payment, $507 000).
     In 1998, Carroll analyzed 46 bile duct injuries by reviewing of medical records,
cholangiograms, videotapes, and surgeon statements2. Factors that predispose to
lawsuits include treatment failures in immediately recognized injuries, complications
that result from delays in diagnosis, and misinterpretation of abnormal cholangiograms.
Injury prevention can be improved by increased awareness of common mistakes.
Improved cholangiographic technique and interpretation should decrease injury
severity, delays in diagnosis, and subsequent morbidity.
     Vilos recently reviewed 40 cases of bowel injury during laparoscopic tubal ligation
that were litigated in Canada3. Of these, the injury was due to the primary trocar (n =
17), scalpel (n = 1), Veress needle (n = 1), Veress needle or undetermined (n = 2), and
fascial suture (n = 1). The small bowel was injured in 9 of 11 entries by the trocar
during diagnostic laparoscopy and in 6 of 14 tubal occlusions. Five injuries in the tubal
occlusion group were attributed to "cautery." The injury was recognized intra-
operatively in 55% of cases. The clinical outcome was uncomplicated in 85% of
patients. There was no difference in clinical outcome between small versus large bowel
injuries and between intra-operative versus post-operative diagnosis of the injury. The
litigation outcome was favorable to the physician in 75% of cases. Recognition was
delayed in 45% of cases and this was associated with 67% of the litigation outcomes
unfavorable to physicians. The authors concluded that the initial laparoscopic entry into
the peritoneal cavity remains the major contributor to bowel injury in laparoscopic
surgery. The open (Hasson) technique does not prevent bowel injuries. Delayed
recognition was a major factor in assessment of liability.
     These three studies demonstrate important factors that predispose to lawsuits and
their outcomes. This information is extremely useful during the rapid evolution of
laparoscopy and its application to more complex procedures including colorectal
surgery.
The role of laparoscopy in colorectal surgery has been slower to evolve because of the
need to tailor techniques to the unique challenges imposed by the colon. Compared to
laparoscopic surgery of the upper gastrointestinal tract and biliary system, the colon is
larger in size, involves all four quadrants of the abdomen and pelvis, and has more
numerous, and often calcified, fat-encased blood vessels. Intracorporeal dissection,
vascular control, bowel resection, and anastomosis require longer operative time which
may limit the potential physiologic and economic advantages. In addition, inflammatory
disorders of the colon, such as ulcerative colitis, Crohn’s disease, and diverticulitis,
require technical expertise to overcome the complications associated with adhesive
disease. Finally, the laparoscopic approach to carcinoma requires application of
oncologic principles to laparoscopic techniques to optimize long-term outcome.
    The currently accepted number of laparoscopic cases appropriate to establish the
learning curve is currently 30. This number results from a series of studies in which data
was analyzed in experienced and nonexperienced surgeons. Schlachta reported on a
prospectively accumulated, computerized database of 461 laparoscopic colorectal
resections performed by three surgeons (See table 1)4. Median operating time was 180
minutes for Cases 1 to 30 in each surgeon's experience and declined to a steady state
(150-167.5 minutes) for Cases 31 and higher. Subsequently, Cases 1 to 30 were
considered "early experience," whereas Cases 31 and higher were combined as "late
experience" for statistical analysis. There were no significant differences between
patients undergoing resections in the early experience and those undergoing resections
in the late experience with respect to age, weight, or proportion of patients with
malignancy, diverticulitis, or inflammatory bowel disease. There were greater
proportions of males (42 vs. 54 percent, P = 0.046) and rectal resections performed (14
vs. 32 percent, P = 0.002) in the late experience. Trends toward declining rates of
intraoperative complications (9 vs. 7 percent, P = 0.70) and conversion to open surgery
(13.5 vs. 9.7 percent, P = 0.39) were observed with experience. Median operating time
(180 vs. 160 minutes, P < 0.001) and overall length of postoperative hospital stay (6.5
vs. 5 days, P < 0.001) declined significantly with experience. There was no difference in
the rate of postoperative complications between early and late experience (30 vs. 32
percent, P = 0.827). The authors concluded that the learning curve for performing
colorectal resections was approximately 30 procedures in this study, based on a decline
in operating time, intraoperative complications, and conversion rate. Learning was also
extended to clinical care because it was appreciated that patients could be discharged to
their homes more quickly.
    Wishner analyzed 150 consecutive laparoscopic-assisted colectomies performed by
a surgical team in an attempt to define a learning curve5. These colectomies performed
by the Norfolk Surgical Group over a 24-month period, were divided chronologically
into six groups of 25 patients each. The groups were then compared to determine if any
improvement in length of procedure, complication rate, conversion rate, or length of
stay developed as experience increased. Colon cancer and diverticular disease were the
most common indications for surgery in all groups. A significant decrease in mean
operative time, from 250 min to 156 min over the first 35-50 cases was observed before
leveling off at approximately 140 min for the remaining group. Intraoperative
complications were low in all groups (range zero to two) and did not show any trend.
There was no statistically significant difference in the conversion rate (23.3% overall)
among the six groups. Length of stay decreased from 6 days in the first two groups to 5
days in the last four groups, although the difference was not statistically significant. The
authors concluded that the learning curve for laparoscopic-assisted colectomies is longer
than appreciated by many surgeons, requiring as many as 35-50 procedures to decrease
operative time to baseline. Complications can be kept at an acceptably low level while
on the curve if a cautious approach is taken and the surgeon realizes that a prolonged
operative time is not only acceptable, but appropriate during this long learning process.
A conversion rate of 20-25% at any phase of the learning process may in fact represent
a limitation of current technology. When combined with a low complication rate it may
be the sign of a careful surgeon.
    Agachan reviewed 175 cases of laparoscopic colorectal procedure in an attempt to
define an operative time curve for different categories of procedures6. Patients were
divided chronologically into five consecutive groups. Procedures were classified as
either basic or complex. Complex procedures were those in which there was either a
fixed tumor, an abscess or fistula, or extensive intraabdominal adhesions from prior
surgery. Complex procedures performed each year ranged from 37% to 66%. As well,
the percentage of patients with adhesions increased from 17% in 1991 to 29% in 1995.
Despite increased difficulty, the intraoperative complication rate fell significantly from
29% in 1991 to 8% in 1995 (p < 0.005) (Tables 2 and 3). Additionally, the operative
length decreased from a mean of 201 min in 1991 to a mean of 141 min in 1995 (p <
0.05). The rapid improvement in these parameters may reflect both ascents in the
learning curve and change in type of procedure. Adhesions, due to prior surgery or
inflammation making dissection tedious, is the most important technical factor which
effects operation time (p < 0.001). However, despite increased complexity, operating
time decreased, reflecting improved skills. Thus, the experienced laparoscopic surgeon
can increase the spectrum of applications with expectations of shorter operations and
lower complication rates.
    Senagore reviewed the experience of his team in determining the learning curve for
laparoscopic colorectal procedures7. Sixty consecutive patients were analyzed and
divided into three groups: First 20, Second 20, and Third 20. The complication rate was
the same for all 3 groups. The third twenty had a significantly shortened hospital stay,
time to flatus, and ileus compared to the first two groups (Tables 5 and 6). The total
hospital cost was consequently lower for the third group. The authors concluded that
successful ascension of the learning curve for laparoscopic- assisted colectomy requires
mastery of technical skills for mobilization of the colon in the presence of significant
adhesions to minimize complications and conversion rates, appropriate selection of
instrumentation for safety and cost effectiveness, and adjustment in post-operative
management.
    Reissman attempted to define the learning curve by analyzing the first 100
laparoscopic or laparoscopy-assisted colorectal operations8. The procedures included 36
total abdominal colectomies (TACs) (ileoanal reservoir 28, ileorectal anastomosis 6,
end-ileostomy 2), 39 segmental resections of the. When divided into three equal,
consecutive groups, the patients in the early (n = 33) and intermediate (n = 33) groups
had a significantly higher complication rate (42% and 27%, respectively), than those in
the late group (n = 34, 12%;p < 0.05) (Tables 6 and 7). The complication rate in each
group was also directly related to the number of TACs performed (18 in the early, 13 in
the intermediate, and 5 in the late group). The overall complication rate in TAC cases
was significantly higher (42%) when compared to that of all other procedures
(segmental resection 9%, nonresectional 12%;p < 0.01). The mean operating time was 4
hours (2.5-6.5 hours) for TAC, 2.5 hours (1.5-5.5 hours) for segmental colonic
resection, and 1.6 hours (1.0-2.5 hours) for the nonresectional procedures. The length of
ileus was 3.5 days (2-7 days) after TAC, 3 days (2-7 days) after the segmental
resections, and 2 days (1-4 days) after the nonresectional procedures. The mean hospital
stay was 7.3 days (2-40 days): 8.4 (5-40), 7.0 (4-12), and 6.8 (2-11) days for the TAC,
segmental resection, and nonresectional procedures, respectively. The authors
concluded that the feasibility of laparoscopic colorectal surgery has been well
established. The morbidity associated with laparoscopic colorectal surgery correlates
with a steep learning curve but is also related to the type of procedure. TAC is
associated with a higher complication rate than are other laparoscopic colorectal
procedures.
    Most recently, Tekkis reviewed the data from 1253 patients undergoinglaparoscopic
surgery between 1991-2003. The average conversin rate was 10%. The independent
predictors of conversion to open surgery higher vody mass index, ASA 3 or 4 type of
resection (low rectal, left colorectal, versus right or other procedures), presende of
intraoperative abcess or fistula, and surgeon seniority (senior versus junior).
    Based on the above reported data of the initial experiences of laparoscopy for
colorectal surgery in several centers ( Table 8), several guidelines with regard to
training, credentialing, and granting of privileges have been established.

TRAINING
        Adequate education and training are essential to minimize the learning curve
anyone who wishes to perform laparosocpic surgery must be adequately trained in the
corresponding open procedure. Training in laparoscopic surgery should be geared
towards 3 categories of physicians: surgeons with no prior experience, surgeons with
prior experience, and residents/fellows.

FORMAL COURSE TRAINING:
•Limited period of instruction that should offer category I Continuing Medical
Education (CME) credits that meet American Medical Association standards
•Should be taught by instructors with appropriate clinical experience
•Must include a didactic portion and as well as hands on experience utilizing inanimate
and/or animate models
•The course director should provide a written assessment of the participant’s mastery of
course objectives
•Documentation for certain courses consisting of only didactic instruction may consist
of verification of attendance
•It is not appropriate training to begin performing a procedure independently

SURGEON WITH NO PRIOR EXPERIENCE
1.Privileging and competence in the corresponding open procedure
2.Privileges by the institution to perform laparoscopic colectomy
3.Learn basic laparoscopic understanding and technique by attending a formal training
course
4.Understand the risks and potential complications
5.Offer the alternative (open) procedure
6.Practice in animal lab or inanimate trainer to become familiar with the instrumentation
and technique
7.Review of published material in the technique and results of lap colectomy, including
review of videos
8.Observership of a selected number of cases
9.Assistance in a selected number of cases
10.Preceptorship or proctorship by qualified surgeons in a selected number of cases
11.Establishment of HIPPA compliant institutional prospective data bank or registry
12.Frequent scrutiny of banked data by peer review should be mandatory

SURGEON WITH PRIOR EXPERIENCE
1.Acquire advanced training
2.Review of published material in laparoscopic colectomy technique, including review
of videos
3.Understanding the risks and potential benefits
4.Practice in animal lab or inanimate trainer to become familiar with the instrumentation
and technique
5.Observership of a selected number of cases
6.Preceptorship or proctorship by a qualified surgeon in a selected number of patients
7.Establishment of an institutional prospective data bank or registry
8.Frequent scrutiny of banked data by individuals other than those contributing the data
1.Laparoscopic surgery incorporated into the curriculum oft the training program
including didactic and laboratory component
2.Observation of the laparoscopic procedure
3.Assistance with the procedure
4.Performance of the procedure assisted and observed by preceptors
5.Entry of all cases into a prospective registry or data bank

CREDENTIALLING GUIDELINES
GRANTING PRIVILEDGES (SAGES/JCACHO Guidelines)
INITIAL PHYSICIAN EVALUATION
MINIMUM REQUIREMENTS
   A.     Candidate with formal residency training in general surgery
   B.     Candidate with formal training in laparoscopy
   C.     Candidate with no formal residency training in laparoscopy
   D.     Practical Experience
**Part A is mandatory, and must be accompanied by either part B, C, or at least
component of part D.

PROVISIONAL PRIVILEDGES
•Once competence has been determined, a period of provisional privileges may be
appropriate
•The time frame and/or number of cases required should be determined by the chief of
surgery and/or the appropriate institutional committee, board, or governing body

MONITORING OF PERFORMANCE
•Performance should be monitored through existing quality assurance mechanisms at
the institution
•Mechanisms should evaluate outcomes, as well as competency in the complete
procedural conduct

CONTINUING MEDICAL EDUCATION
•CME related to laparoscopic surgery should be required as part of the periodic renewal
of privileges
•Attendance at appropriate local, national or international meeting and courses is
encouraged

RENEWAL OF PRIVILEDGES
•An appropriate level of continuing clinical activity should be required which should
include quality assurance data, CME activity in addition to existing mechanisms at the
institution designed for this purpose
DENIAL OF PRIVILEDGES
•Institutions denying, withdrawing, or restricting privileges should have an appropriate
mechanism for appeal in place
•The procedure details should be developed by the institution and must satisfy the
intuition's bylaws and JCAHO recommendations
CONCLUSIONS
        Laparoscopic colectomies are advanced procedures and should be undertaken
only by qualified surgeons. More important than numbers, surgeons should prove
proficiency. Guidelines help to define the degree of experience, exposure, and support
considered minimally acceptable credentials for surgeons requesting privileges to
perform laparoscopic surgery. After initial credentialing, monitoring of outcomes is
warranted


REFERENCES
  1. Kern KA. Malpractice litigation involving laparoscopic cholecystectomy. Cost,
     cause, and consequences. Archives of Surgery. 132(4):392-7, 1997 Apr.
  2. Carroll BJ. Birth M. Phillips EH. Common bile duct injuries during laparoscopic
     cholecystectomy that result in litigation. Surgical Endoscopy. 12(4):310-3;
     discussion 314, 1998 Apr.
  3. Vilos GA. Laparoscopic bowel injuries: forty litigated gynecological cases in
     Canada. [Case Reports. Journal Article. Legal Cases] Journal of Obstetrics &
     Gynecology Canada: JOGC. 24(3):224-30, 2002 Mar.
  4. Schlachta CM. Mamazza J. Seshadri PA. Cadeddu M. Gregoire R. Poulin EC.
     Defining a learning curve for laparoscopic colorectal resections. Diseases of the
     Colon & Rectum. 44(2):217-22, 2001 Feb.
  5. Wishner JD. Baker JW Jr. Hoffman GC. Hubbard GW 2nd. Gould RJ.
     Wohlgemuth SD. Ruffin WK. Melick CF. Laparoscopic-assisted colectomy. The
     learning curve. Surgical Endoscopy. 9(11):1179-83, 1995
  6. Agachan F. Joo JS. Sher M. Weiss EG. Nogueras JJ. Wexner SD. Laparoscopic
     colorectal surgery. Do we get faster? Surgical Endoscopy. 11(4):331-5, 1997
     Apr.
  7. Senagore AJ. Luchtefeld MA. Mackeigan JM. What is the learning curve for
     laparoscopic colectomy?. American Surgeon. 61(8):681-5, 1995 Aug.
  8. Reissman P. Cohen S. Weiss EG. Wexner SD. Laparoscopic colorectal surgery:
     ascending the learning curve. World Journal of Surgery. 20(3):277-81;
     discussion 282, 1996 Mar-Apr.
  9. Tekkis, Senagore, Delaney. Conversion rates in laparoscopic colorectal surgery:
     A predictive model with 1253 patients. Surg Endosc 19:47-54, 2005.
Table 1. Defining a learning curve from laparoscopic colorectal resections4.
Outcome                                Early results              Late results
                                       < 30 cases                 > 30 cases
Intraoperative complications (%)       9                          7
Conversion rate (%)                    13.5                       9.7
Operating time (mins)*                 180                        160
Postoperative complications (%)        30                         32
Length of stay (Days)*                 6.5                        5
* P<0.001
      Table 2. Complications relative to time interval6.


Groups           n       Age         1991- 1992- 1993- 1994-                  Total
                                     1992 1993 1994 1995
I               37         32         8/30          2/7           0     0/0   10/37
II              79         58         5/19         2/18         0/23   1/19   8/79
III             29         46          1/3          0/6         1/14    0/6   2/29
VI              22         57          3/6          0/5          2/7    1/4   6/22
Total           16        50       17/58           4/36         3/44   2/29   26/16
                 7                     *
      Group I – Total abdominal colectomies                                     7
      Group II – Segmental resections
      Group III – Diverting procedures
      Group !V - Others (Hartmann’s reversal, rectopexy, etc)
   Table 3. Logistic regression analysis for complications6.


Prognostic factor                                       Odds ratio     P value

Univariate

Treatment Group                                                        0.028
Group I vs. Group II                                           0.304   0.024
Group I vs. Group III                                          0.200   0.050
Group I vs. Group IV                                           1.013   0.984

Year of surgery                                                0.481   0.002

Size of incision (cm)                                          1.100   <0.001


Duration of surgery (min)                                      0.992   0.060

Gender                                                         1.118   0.800

Age (yr)                                                       0.988   0.300

Multivariate

Year of surgery                                                0.533   0.010

Size of incision                                               1.095   0.002
       Table 4. Operative characteristics and complications7.

                                          First twenty          Second twenty   Third twenty

Prior surgery (%)                               10                   65             55
Intra-op bleed                                   0                   1               0
Acidosis                                         1                   0               0
Enterotomy                                       0                   4               0
Pulmonary                                        6                   1               1
Wound infection                                  0                   0               0
Prolonged ileus                                  3                   1               0
Post-op bleed                                    1                   1               0
Operating time                                  185                 185             160
Conversion (%)*                                 20                   45             10

       P<0.05
    Table 5. Post-operative course and costs7.


                                                  First   Second    Third
                                                 twenty   twenty   twenty

First flatus (days)*                              3.7      3.1      1.9
First bowel movement (days)*                      3.9      4.2      2.8
First oral intake (days)*                         3.9      3.3      1.6
Length of stay (days)*                            6.8      6.6      4.2
OR cost ($)                                      3003     2988     4215
Total hospital cost ($)*                         13965    14063    11860

    *p<0.05
    Table 6. Complication in 100 patients undergoing laparoscopic procedures based on
    whether in early, intermediate, or late groups8.


                                       Early         Intermediate            Late       Total
                                       Group            Group               Group

n                                            33             33                 34        100
Overall complications                 13 (42)*           9 (27)*            4 (12)        26
N of TACs                                    18             13                 5          36
Complications of TAC                   9 (50)             5 (38)            1 (20)      15 (42)
N of other procedures                        15             20                 29         64
Complications with other               4 (27)             4 (20)           3 (10)**     11 (17)
procedures

Conversion to laparotomy                3 (9)             1 (3)              3 (9)       7 (7)


    Values in parentheses are percentages.
    *p<0.05
    **p<0.01
    Table 7. Complications based on type of procedure8.

                                    TAC          Segmental    Nonresection   Total
                                                 resections    procedures


n                                    36               47          17         100

Complications                      15 (42)*         9 (19)       2 (12)       26

Length of the                         4              2.5          1.6*        2.8
procedure (hours)

Length of the ileus                  3.5                  3        2          3
(days) mean

Hospitalization (days)               8.4                  7       6.8         7.3
mean


    *p<0.01




    Table 8. The learning curve.
                 N      Time    Op time     Complication   Conversion   Learning
                       period                  rate           rate       curve

Wishner, 95     150      2      Decreased      Same          Same         35-50



Simons, 95      144      -      Decreased        -             -          11-15

Senagore, 95     60      4      Decreased    Decreased       Same       Surgeon &
                                                                         disease
                                                                         specific
Agachan, 96     175*     4      Decreased    Decreased                     70

Reissman, 96    100*     3          -        Decreased         -           66

Bennett, 97     1194     3          -        Decreased       Same          40

Schlachta, 01   461      8      Decreased      Same          Same          30

Dincler, 03     715      8      Decreased        -         Decreased      70-80

				
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