Laparoscopy 50

50

Laparoscopy

Peter W. Marcello and Tonia Young-Fadok

693 Until recently, there has been a relatively slow adoption of

laparoscopic colectomy into the surgeon’s practice. The per- sistence of the learning curve, the modest advantages reported, and the concerns regarding the safety of laparo- scopic resection for curable colon cancer are but a few of the reasons that the percentage of laparoscopic colorectal proce- dures has not dramatically increased. With the publication of the several large prospective, randomized trials for colon can- cer, however, there seems to be a renewed interest in mini- mally invasive procedures for the colon and rectum. This chapter will review these issues and provide a current assess- ment of the field for the common disease processes to which laparoscopic techniques have been applied.

Learning Curve

Laparoscopic colorectal surgery has met with certain chal- lenges that distinguish it from other minimally invasive pro- cedures. In comparison to laparoscopic cholecystectomy, the surgeon performing laparoscopic colectomy has to work in multiple quadrants of the abdomen. This requires a better understanding of depth perception and proprioception. A coordinated team consisting of a surgeon, an assistant, and often a camera person is required. All three must work together along with the nursing and anesthesia teams. The surgeon may also need to work in reverse angles to the cam- era. All of these combined add to the complexity of the pro- cedure and result in the need to perform a number of cases before the surgeon and surgical team will become proficient.

Numerous previous studies have evaluated the “learning curve” of laparoscopic colectomy.^1–3It is estimated that with conventional laparoscopic techniques and instruments that the learning curve for laparoscopic colectomy is at least 20 cases and more likely 50 cases.

Recent publications have suggested the learning curve is more than 20 cases. In a prospective, randomized study of col- orectal cancer in the United Kingdom, the “CLASICC” trial, surgeons had to perform at least 20 laparoscopic resections

before they were allowed to enter the study.⁴The study began in July 1996 and was completed in July 2002. Despite the surgeons’ prior experience, the rate of conversion decreased from 38% to 16% over the course of the study, suggesting that a minimum of 20 cases may not be enough to reach the plateau of the “learning curve.” In the COLOR trial from Europe,⁵ another recent prospective randomized study for colon cancer that required a prerequisite experience in laparo- scopic colon resection before surgeons could enter patients into the study, surgeon and hospital volume were directly related to a number of operative and postoperative outcomes.

The median operative time for high-volume (>10 cases/year) hospitals was 188 minutes compared with 241 minutes for low-volume (< 5 cases/year) hospitals, and likewise conver- sion rates were 9% versus 24% for the two groups. High- volume groups also had more lymph nodes in the resected specimens, fewer complications, and shortened hospital stay.

These two recent studies would suggest that the learning curve is clearly greater than 20 cases and that surgeons need to perform a minimum yearly number of procedures to main- tain their skills.

The difficulty with the broad application of laparoscopic colectomy is that most general surgeons perform fewer than 50 segmental colon resections per year. In a review of 2434 general surgeons who were taking the recertification exami- nation for the American Board of Surgery, all of whom sup- plied their operative lists from the previous year, most surgeons performed fewer than 20 colon resections in 1 year.⁶ In fact, the mean number of colon resections performed by a surgeon was 11. Even at the 90th percentile, only 23 colec- tomies were performed by a surgeon in a single year. If the average surgeon performs 11 resections and only half are eli- gible for a laparoscopic approach, assuming a learning curve of 40 cases, it would take a surgeon 8 years to feel comfort- able performing laparoscopic colectomy. Most surgeons can- not afford to go through such a learning curve. Either the learning curve will need to be shortened, as some have suggested by the use of hand-assisted laparoscopic (HAL) techniques, or we will need to limit the performance of

laparoscopic colectomy to surgeons who perform a greater number of colon resections per year.

Conversions

The rates of conversion are inconsistent in the literature, with reports as low as 0% to as high as 48%. Most series report the need to convert in 10%–25% of cases. Although surgical pro- ficiency would likely decrease the need to convert, this is counterbalanced by the surgeon’s desire to perform more com- plex cases. Several patient- and disease-related factors such as obesity, prior abdominal surgery, acuity of inflammation (i.e., abscess and fistula formation), tumor bulk or contiguous involvement, and disease location, may also affect the rate of conversion. Obesity, defined as a body mass index >30 kg/m², was once considered a relative contraindication for a laparo- scopic colon resection. For a surgeon early in their learning curve it should probably remain a relative contraindication.

However, once more experience is gained by the surgeon, sev- eral current reports have demonstrated that obesity itself in not a contraindication to a minimally invasive approach.^7–9 For inflammatory conditions such as Crohn’s disease and divertic- ulitis, the presence of an abscess or fistula may result in the need for conversion in up to 50% of cases.^10,11More recent studies of laparoscopic surgery involving enteric fistulae sug- gest a conversion rate of 25%–35%.^12–14The presence of a fis- tula or small abscess is not a contraindication to a minimally invasive approach, but should alert the surgeon to consider a variation in operative approach if obstacles cannot be over- come. Conversion from a laparoscopic to conventional resec- tion should not be viewed as a failure of the laparoscopist. It is difficult to predict based on preoperative studies which cases cannot be completed laparoscopically. More crucial than the rate of conversion is the time spent before conversion. An ini- tial laparoscopic survey may quickly identify a complex process, allowing a speedy alteration in the operative plan. If the approach is expeditiously changed, little additional time or costs need be incurred. Earlier reports suggested a poorer out- come for patients who required conversion; however, more recent studies, including a recent presentation of the COST trial results, suggest that if conversion is made early the out- come of converted cases is similarly matched with patients undergoing conventional surgery.^15,16The goal is to perform a preemptive conversion once it is determined the case cannot be completed laparoscopically, rather than a reactive conversion to a complication that occurred because of adverse conditions that the surgeon could have avoided.

Outcomes

In comparison to conventional colectomy, the proposed bene- fits of laparoscopic colectomy include a reduction in postop- erative ileus, less postoperative pain and concomitant reduction in the need for analgesics, an earlier tolerance of

diet, a shortened hospital stay, a quicker resumption of normal activities, improved cosmetic results, and possibly preserva- tion of immune function. This is offset by a prolongation in operative time, the cost of laparoscopic equipment, and the learning curve of these technically challenging procedures.

When reporting the outcomes of laparoscopic colectomy, there is however, a natural selection bias when comparing conventional and laparoscopic cases. More complex cases are generally not suitable for a laparoscopic approach and there- fore are performed “open.” Also, in many series the results of the successfully completed laparoscopic cases are compared with conventional cases and the cases converted from a laparoscopic to conventional procedure. Few studies, with the exception of the larger prospective, randomized studies, leave the “converted” cases in the laparoscopic group as part of the

“intention to treat” laparoscopic group. This clearly intro- duces selection bias. In addition, there is wide variability in the types of laparoscopic procedures performed, the reporting of results, and cultural variations in patient management.

Although the results of prospective, randomized trials are becoming more available, the majority of studies of laparoscopic colectomy are retrospective case control series or noncompara- tive reports. The conclusions regarding patient outcomes, there- fore, must come from the repetitiveness of the results rather than the superiority of study design. For any one study, the evidence is weak, however collectively, because of the reproducibility of results by a large number of institutions, even with different operative techniques and postoperative management parame- ters, the preponderance of evidence favors a minimally invasive approach with respect to postoperative outcomes. Also, the prospective, randomized studies that are available corroborate the findings demonstrated in nonrandomized studies.

Operative Time

Nearly all the comparative studies provide information regarding operative times. The definition of the operative time may vary with each series, and there may be different groups of surgeons performing the laparoscopic and conventional procedures. With the exception of a few reports, nearly all studies demonstrated a prolonged operative time associated with a laparoscopic procedure. In prospective, randomized trials, the procedure was approximately 40–60 minutes longer in the laparoscopic groups. As the surgeon and team gain experience with laparoscopic colectomy, the operating times do reliably decrease, but rarely do they return to the compa- rable time for a conventional approach.

Return of Bowel Activity and Resumption of Diet

Reduction in postoperative ileus is one of the proposed major advantages of minimally invasive surgery. Nearly all of the historical and prospective studies comparing open and

laparoscopic colectomy have shown a statistically significant reduction in the time to passage of flatus and stool. Most series demonstrate a 1- to 2-day advantage for the laparoscopic group. Whether the reduction of ileus relates to less bowel manipulation or less intestinal exposure to air, or some other factor, during minimally invasive surgery remains unknown.

In clinical studies, it is difficult to eliminate all the biases of the treating physician and the higher expectations of the patient undergoing laparoscopic surgery. Psychological con- ditioning of the patient preoperatively may interfere with an objective assessment of bowel activity postoperative. To more formally answer this question, both human and animal stud- ies have evaluated the return of gastrointestinal motility. Both canine and porcine models have confirmed an earlier return of intestinal myoelectric activity after laparoscopic resec- tion.^17,18Another study in dogs demonstrated a quicker return to preoperative motility, using radionucleotide techniques in animals subjected to laparoscopic resection.¹⁹These studies clearly demonstrate a quicker return of bowel activity without the subjective bias that may be introduced in clinical studies.

With the reduction in postoperative ileus, the tolerance by the patient of both liquids and solid food is quicker after laparoscopic resection. The time to resumption of diet varies from 2 to 7 days, but in the majority of comparative studies, this still remains 1–2 days sooner than in patients undergoing conventional surgery. Again, the physician and patient were not blinded, which may alter patient expectations. The over- whelming reproducible data reported in both retrospective and prospective studies of laparoscopic procedures, however, do likely favor a reduction of postoperative ileus and tolerance of liquid and solid diet.

Postoperative Pain and Recovery of Pulmonary Function

To measure postoperative pain, a variety of different assess- ments have been performed to demonstrate a significant reduction in pain after minimally invasive surgery; some stud- ies use an analog pain scale, whereas others measure narcotic requirements. Physician bias and psychological conditioning of the patients may interfere with the evaluation of postoper- ative pain. There are also cultural variations in the response to pain. Three of the early prospective, randomized trials have evaluated pain postoperatively and all three have found a reduction in narcotic requirements in patients undergoing laparoscopic colectomy.^20–22In the COST study,^23,24the need for both intravenous and oral analgesics was less in patients undergoing successfully completed laparoscopic resections.

Numerous other nonrandomized studies have shown a reduction in postoperative pain and narcotic usage.

Closely related to the severity and duration of postoperative pain is the return of pulmonary function. Adequate pain management allows the patient to inspire more deeply. After conventional abdominal surgery, suppression of pulmonary function is a well-known sequelae. Several studies of

laparoscopic colectomy have evaluated the return of pulmonary function. In the randomized clinical trial of patients undergoing surgery for colon cancer from the Cleveland Clinic, preoperative and postoperative spirometry was performed every 12 hours in 55 patients in the laparoscopic group and 54 patients in the con- ventional group.²⁰ An 80% recovery of baseline-forced vital capacity and forced expiratory volume in one second was meas- ured in each patient. The median recovery for the laparoscopic group was 3 days which was half the recovery (6 days) seen in the conventional group. A similarly designed study by Schwenk et al.²²confirmed these same results. Whether subject to bias, the results of comparative studies suggest a quicker recovery of pulmonary function and reduction in postoperative pain in patients subjected to laparoscopic colectomy.

Length of Stay

The quicker resolution of ileus, earlier resumption of diet, and reduced postoperative pain have resulted in a shortened length of stay for patients after laparoscopic resection when com- pared with traditional procedures. Recovery after conven- tional surgery has also been shortened by early feeding practices introduced more recently, but this is not consistent throughout the literature. In the absence of minimally invasive techniques, it would seem unlikely that the length of stay could be further reduced. In nearly all comparative studies, the length of hospitalization is 1–6 days less for the laparo- scopic group. In an attempt to minimize the differences between a conventional midline incision and a laparoscopic incision, Fleshman et al.²⁵ compared the outcomes of 35 patients whose surgery was performed through a minila- parotomy (12 cm, mean incision length) with 54 laparoscopic patients. Outcome was similar for both groups with a mean day of discharge of 6.9 days (range, 3–15 days) for the mini- laparotomy group and 6.0 days for the laparoscopic group (range, 1–15 days). However, when the results of successfully completed laparoscopic cases (75%) were compared, the results favored the laparoscopic group (5.3 days; range, 1–14 days). Therefore, despite an attempt to minimize the incision, the overall length of stay was significantly longer.

Although psychological conditioning of the patient cannot be helped and likely has a desirable effect, the benefits of minimally invasive procedures on the overall length of stay cannot be discounted. The benefit, however, is more likely a 1- to 2-day advantage only. The more recent introduction of clinical pathways both in conventional and laparoscopic sur- gery has also narrowed the gap, but seems to be more reliable in patients undergoing a minimally invasive approach.^26,27

Quality of Life and Return to Work

If laparoscopic colectomy results in less postoperative pain and earlier return to normal activities, then one would antici- pate that the quality of life after a laparoscopic procedure

should be improved when compared with conventional proce- dures. Unfortunately, despite the numerous reports of laparo- scopic colectomy, few have objectively examined the patient’s assessment of recovery. In a nonrandomized study, Psaila et al.²⁸ evaluated the recovery of hand-grip strength and the patient’s quality of life using an SF-36 symptom score 2 months and 4 months postoperatively. Hand-grip strength, as a measure of protein loss, recovered more rapidly after laparoscopic surgery. Using the SF-36 questionnaire, in six of eight areas of questioning, there was less impairment of health after laparoscopic colectomy. By 4 months postopera- tively, this trend persisted, but to a lesser degree. In the COST study, quality of life was evaluated by three complementary viewpoints: patient self-reported symptoms, patient self- reported functional status, and a third more objective meas- urement scale of compliance to treatment referred to as Q-TWIST (quality-adjusted time without symptoms of dis- ease and toxicity of treatment).²³ Because of a high conver- sion rate of 25% in the initial study report, and the “intention to treat” design of the study, there were no significant differ- ences between the conventional and laparoscopic groups with the exception of a global rating score 2 weeks after surgery. In every category, however, the results of patients who had a laparoscopically completed procedure were improved com- pared with conventionally performed procedures and in laparoscopic patients who required a conversion to open sur- gery. However, this did not achieve significance. The results of the CLASICC trial in the United Kingdom found similar results.⁴

Only a few studies have assessed the ability of patients undergoing laparoscopic colectomy to return to work. With less postoperative pain and reduced narcotic usage, one would presume that patients undergoing a minimally invasive approach would return more quickly to normal activities and employment compared with patients undergoing a conven- tional resection. In a nonrandomized comparison, patients undergoing laparoscopic procedure returned to full activities and to work sooner than matched patients undergoing con- ventional resection [mean, 4.2 versus 10.5 weeks, 3.8 versus 7.5 weeks, respectively (P < .01 for all)].²⁹

Hospital Costs

One of the proposed disadvantages of laparoscopy is the higher operative costs related to longer operative times and increased expenditure in disposable equipment. Whether the total cost of the hospitalization (operative and hospital costs) is higher after laparoscopic colectomy is debatable. A case control study from the Mayo Clinic has looked at total costs after laparoscopic and open ileocolic resection for Crohn’s disease.³⁰ Sixty-six patients underwent laparoscopic (n = 33) or conventional (n = 33) ileocolic resection during the same time period (10/95–7/99) and were well matched. Patients in the laparoscopic group had less postoperative pain, tolerated

a regular diet sooner by 1–2 days, and had a shorter length of stay (4.0 versus 7.0 days). In their cost analysis, despite higher operative cost, the overall mean costs were $3273 less in the laparoscopic group. The procedures were performed by different groups of surgeons at the institution, and although the surgeon may have introduced biases, this study was under- taken during the current era of cost containment in which all physicians are encouraged to reduce hospital stay. Other stud- ies by Dupree et al.³¹ and Shore et al.³² have confirmed these findings with a mean reduction of $438 in costs and $7465 in hospital charges, respectively, in patients undergoing laparo- scopic compared with conventional ileocolic resection. The results are similar for elective sigmoid diverticular resection with a mean cost savings of $700–$800.³³ Clearly, if operative times and equipment expenditure are minimized, the overall cost of a laparoscopic resection should not exceed a conven- tional approach.

Crohn’s Disease

Laparoscopy in the setting of inflammatory bowel disease has its own set of unique challenges that must be overcome. For patients with Crohn’s disease, the dissection is hampered by inflammatory changes in the mesentery, difficulty in assess- ing bowel involvement and identifying normal anatomic land- marks, along with the development of associated abscess and fistulous disease often seen in the Crohn’s patient. For the ulcerative colitis patient and the patient with isolated Crohn’s colitis, the challenges are more technical because of the difficulty in performing laparoscopic total colectomy.

Crohn’s disease of the terminal ileum seems an ideal model for the application of a minimally invasive approach. The dis- ease is usually limited to one area of the abdomen and only mobilization and vascular pedicle ligation are required laparoscopically. The resection and anastomosis are generally performed extracorporeally. Patients with Crohn’s are typi- cally young and are interested in undertaking a procedure that minimizes incisional scarring. Additionally, because many of these patients will require reoperation over their lifetime, a minimally invasive approach is appealing. Early reports of laparoscopic ileocolic resection showed it to be feasible and safe, but were typically small nonrandomized uncontrolled studies. More recent studies (Table 50-1) have a larger expe- rience in which to draw more meaningful conclusions.^35–47 The majority of studies, however, are retrospective case con- trol series. Most series report the rate of conversion from 10%

to 20% with the mix of complex cases (abscess, fistula, or reoperative surgery) ranging from 40% to 50%.

As expected, the outcomes after laparoscopically assisted ileocolic resection for Crohn’s disease mirror those seen in other studies of laparoscopic colectomy for benign and malig- nant disease. In comparative studies (Table 50-1), laparo- scopic ileocolic resection is associated with a quicker return of bowel function and an earlier tolerance of oral diet. The

TABLE50-1.Recent studies of laparoscopic resection for Crohn’s disease: ileocolic resection No. of patientsOP time (min)LOS (d)Morbidity (%) AuthorYearLAPCONLAPCONLAPCONLAPCONComment Bauer etal.3519962514——6.58.5——High conversion if mass and fistula Wu etal.36199746701442024.57.9102152% complex or redo cases Dunker etal.3719981111——5.59.999Improved cosmesis Wong etal.381999551506.0546% complex cases Canin-Endres etal.391999701834.21441 with fistulae, 1 conversion Alabaz etal.4020002648150907.09.6——Favorable results Bemelman etal.41200030481381045.710.21510Different hospitals for each group Young-Fadok etal.30200133331471244.07.0——Laparoscopy less expensive Schmidt etal.422001462075.7Safe and effective, high conversion rate Milsom etal.4320013129140855.06.01628Prospective, randomized trial Evans etal.442002841455.611Results improve with experience Dupree etal.312002212475983.05.01416Laparoscopy less expensive Shore etal.32200320201451334.38.2——Laparoscopy less expensive Benoist etal.45200324321791987.78.02010Similar operative times, 17% converted Bergamaschi etal.47200339531851055.611.2910Long-term obstruction less, 11% versus 35% OP, operative; LOS, length of stay; LAP, laparoscopic; CON, conventional.

quicker resolution of ileus, earlier resumption of diet, and reduced postoperative pain has resulted in a shortened length of stay for patients after laparoscopic resection when com- pared with traditional procedures. Milsom et al.⁴³ published a prospective, randomized trial comparing conventional and laparoscopic ileocolic resection for refractory Crohn’s dis- ease. Sixty patients were randomized to either conventional or laparoscopic resection after an initial diagnostic laparoscopy to assess feasibility of a laparoscopic resection. The results favor a laparoscopic approach with regard to pulmonary function, morbidity, and length of stay. There were no appar- ent short-term disadvantages. All patients had oral intake withheld for 3 days to evaluate nutritional parameters. This impacted on the timing of dietary intake and was likely responsible for a delay in discharge in some patients. The total length of stay in this randomized study was 1 day shorter in the laparoscopic group (5 versus 6 days) but did not reach statistical significance. Had dietary intake not been withheld, a shortened length of stay of the laparoscopic group might have achieved significance.

With the loss of tactile sensation, one of the remaining con- cerns of performing laparoscopic surgery in the patient with terminal ileal Crohn’s is missing an isolated proximal lesion.

Many patients after ileocolic resection will develop a sympto- matic recurrence proximal to the ileocolic anastomosis, but whether patients undergoing a laparoscopic procedure will present with unrecognized proximal disease remains unclear.

There are now, however, several studies that have reported recurrence rates after laparoscopic ileocolic resection. In a recent article, the long-term follow-up (mean 39 months) of 32 patients over 7 years who underwent a laparoscopic ileo- colic resection were compared with 29 patients undergoing open resection.⁴⁶ The rate of Crohn’s recurrence was high but similar in both groups (48% laparoscopic, 44% conventional) as was the disease-free interval (24 months). In another recent review of long-term outcome, Bergamaschi et al.⁴⁷ reported the results of 39 laparoscopic and 53 conventional ileocolic resections with a 5-year follow-up. Recurrent disease was determined by patient symptoms and confirmed both radi- ographically and endoscopically in 27% of patients undergo- ing a laparoscopic procedure and in 29% of patients with a conventional resection. Interestingly, the incidence of small bowel obstruction was significantly less in the laparoscopic group (11% versus 35%, P = .02). This was thought to be the result of less adhesion formation after a laparoscopic proce- dure. Laparoscopic ileocolic resection does not seem to offer any advantage over conventional resection with regard to symptomatic recurrence, but it also did not lead to a higher rate of recurrence or discovery of a missed lesion.

Laparoscopic ileocolic resection for Crohn’s disease seems to be safe and feasible and offers the advantages seen in other reports of laparoscopic colorectal procedures. For the inexperienced laparoscopist, the initial uncomplicated termi- nal ileal resection is an ideal procedure in which to gain laparoscopic experience. An initial laparoscopic survey

should be performed in the majority of patients with refrac- tory ileal Crohn’s disease with a low threshold to alternate the approach if a complex case beyond the skill of the surgeon is encountered.

Ulcerative Colitis

There are no prospective, randomized studies of laparoscopic proctocolectomy for ulcerative colitis. The only results avail- able for analysis are prospective and retrospective case con- trol studies and noncomparative reports (Table 50-2).^48–59 Several reasons likely account for the slow acceptance of laparoscopic proctocolectomy including the steep learning curve to performing even segmental colectomy, the technical challenges of transverse colon resection, and the unfavorable early reports of laparoscopic total colectomy. The group from Cleveland Clinic Florida attempted laparoscopic proctocolec- tomy for patients with ulcerative colitis in the early 1990s and published several comparative reports.^60,61The results showed a longer operative time and higher blood loss than matched open procedures with no apparent benefit. The authors dis- couraged the use of minimally invasive techniques for patients requiring total colectomy. This was an appropriate recommendation during the early era of laparoscopic colec- tomy. However, with advances in technology and experience gained with segmental resection, many groups have reevalu- ated the role of laparoscopic total colectomy for inflammatory bowel disease.

The majority of reports have shown that laparoscopic total colectomy and laparoscopic proctocolectomy with and with- out ileoanal pouch construction are technically feasible and share the same advantages of minimally invasive surgery as segmental colonic resection. Laparoscopic proctocolectomy has been performed in the elective setting, but several groups have performed laparoscopic total colectomy on an urgent basis for the patient with unresolving acute colitis. These pro- cedures, however, are still not recommended for the patient with toxic colitis.

Even though some groups perform this procedure routinely, the procedures remain technically challenging with operative times in the 3- to 5-hour range. In an effort to reduce opera- tive times, several groups have recently reported the use of hand-assisted techniques for restorative proctocolectomy.^57,59 In a small comparative study from the Lahey Clinic, the effec- tiveness of the HAL approach was compared with a conven- tional laparoscopic method in patients undergoing laparoscopic proctocolectomy.⁵⁷Both groups [10 HAL versus 13 standard laparoscopy (SL)] were well matched, with no differences in age, sex, ASA level, operative indication, steroid usage, or diagnosis. The results demonstrated no dif- ferences in incision size (mean 8 cm), operative blood loss, rate of conversion (HAL 10% versus SL 0%), or com- plications (HAL 40% versus SL 31%). The operative times progressively decreased in the hand-assisted group (mean

247 minutes) while remaining constant in the laparoscopic group (mean 300 minutes, P < .05) over the period of study.

This 1-hour reduction in operative is significant to the busy practicing surgeon and may open the door to more surgeons in performing laparoscopic restorative proctocolectomy.

Another recent study by Nakajima et al.⁵⁹ showed similar advantages of hand-assisted total colectomy for ulcerative colitis. It seems that hand-assisted restorative proctocolec- tomy can be accomplished without detriment to bowel func- tion, length of stay, or patient outcome.

The role of laparoscopic total colectomy for patients with inflammatory bowel disease is not well defined, but is likely to expand as surgeons become more comfortable with seg- mental resection. Advantages seen in segmental resection have recently been reproduced in patients undergoing laparo- scopic total colectomy. Again, although the evidence based on study design and size for any one report is not optimal, the reproducibility of the results among many institutions pro- vides adequate evidence to demonstrate clear advantages of laparoscopic total colectomy for ulcerative colitis over a con- ventional approach. The use of HAL for ulcerative colitis patients requiring surgery is likely another venue that may shorten operative time while maintaining the benefits of a minimally invasive approach.

Diverticulitis

Laparoscopic sigmoid resection remains the leading indica- tion for minimally invasive colon resection for benign dis- ease. The surgery is hampered by both the fibrotic changes associated with elective resection of recurrent disease and the inflammatory changes associated with acute disease. As sur- geons acquire their laparoscopic skills, more complex cases involving abscess and fistulous communications have been successfully completed laparoscopically. There are now a large number of studies evaluating laparoscopic surgery for diverticulitis (Table 50-3).^62–75 These are both large case series and nonrandomized comparative studies with open resection. Most series report an operative time of 2–3 hours with a conversion rate of 10%–20% for most larger series.

The largest series of diverticular resection comes from a German multi-institutional study of 1545 patients accumu- lated over 7 years at 52 institutions.⁶⁸ The study demonstrated a low morbidity and mortality with an overall conversion rate of 6.1%. As experience increased, the percentage of complex cases increased without significantly altering the morbidity or rate of conversion. High-volume centers performed more of the complex cases with a similar conversion rate to the low- volume centers that performed less complex cases.

TABLE 50-2. Recent studies of laparoscopic colectomy for ulcerative colitis

Author Year No. of patients Comment

Meijerink et al.⁴⁸ 1999 10 Feasible, 7 for acute colitis

Marcello et al.⁴⁹ 2000 13 Restorative proctocolectomy, favorable results

Seshadri et al.⁵⁰ 2001 37 25% morbidity

Hamel et al.⁵¹ 2001 21 Compared with ileocolic resection, similar morbidity and LOS Marcello et al.⁵² 2001 16 For acute colitis, comparative study, favorable results

Brown et al.⁵³ 2001 25 Longer op time in LAP group

Dunker et al.⁵⁴ 2001 35 Better cosmesis

Ky et al.⁵⁵ 2002 32 Single-stage procedure, good results

Bell and Seymour⁵⁶ 2002 18 Total colectomy for acute colitis, seems safe Rivadeneira et al.⁵⁷ 2004 23 Hand-assisted procedure reduced operative time Kienle et al.⁵⁸ 2003 59 Large study, laparoscopic colon mobilization only Nakajima et al.⁵⁹ 2004 16 Hand-assisted technique, favorable results IPAA, ileal pouch–anal anastomosis; EBL, estimated blood loss; LOS, length of stay.

TABLE50-3A. Compiled descriptive series of laparoscopic resection for diverticulitis

Mortality Morbidity Conversion OR time Resume Flatus/

Study Year N (%) (%) (%) (min)^* diet (d)^* BM (d)^* LOS (d)^*

Eijsbouts et al.⁶² 1997 41 0 18 15 195 NA NA 6.5

Stevenson et al.⁶³ 1998 100 0 21 8 180 2 2 4

Tuech et al.⁶⁴ 2000 77 0 17 14 NA NA NA NA

Trebuchet et al.⁶⁵ 2002 170 0 8.2 4.1 141 3.4 NA 8.5

Bouillot et al.⁶⁶ 2002 179 0 15 14 223 3.3 2.5 9.3

Pugliese et al.⁶⁷ 2004 103 0 8 3 190 NA 4 9.7

Schneidbach et al.⁶⁸ 2004 1545 0.4 17 6.1 169 NA NA NA

Pessaux et al.⁶⁹ 2004 582 1.2 25 NA NA NA NA NA

Schwandner et al.⁷⁰ 2005 363 0.6 22 6.6 192 2.8 4.0 11.8

OR, operating room; BM, bowel movement, LOS, length of stay; NA, not available.

*Median or mean values listed.

TABLE50-3B.Case-control studies pertaining to laparoscopic resection for diverticulitis No. of paientsMortality (%)Morbidity (%)Convert OR time (min)*Resume diet (d)*Flatus/BM (d)*LOS (d)*Total costs* StudyYearCONLAPCONLAPCONLAP(%)CONLAPCONLAPCONLAPCONLAPCONLAP Diverticulitis Liberman etal.711996141400141401821926.12.9†NA9.26.3†P 13,40011,500 Bruce etal.721996172500231612115397†5.73.2†NA6.84.2†$ 7,06810,230† Kohler etal.73199834270061157121165†5.84.1†5.33.7†14.37.9†DM 8,9757,185† Senagore etal.332002716101.6308†7101107NANA6.83.1†$ 4,3213,458† Dwivedi etal.342002886600241820143212†4.92.9†NA8.84.8†$ 14,86313,953† Lawrence etal.742003215561.61279†7140170†NANA9.14.1†$ 25,70017,414† ‡Gonzalez etal.7520048095413119†NA156170NA3.72.8127†NA OR-operating room; BM-bowel movement, LOS-length of stay; CON-conventional surgery; LAP-laparoscopic surgery; NA-not available; P, pounds; DM, Deutsch Marks. *Median or mean values listed. †Statistically significant difference. ‡Results of non-converted laparoscopic cases given. §Minilaparotomy.

Nearly all comparative studies of laparoscopic to open sig- moid resection demonstrate a benefit to the laparoscopic approach including a shorter duration of ileus, shortened length of stay, but as in other studies, with a prolonged opera- tive time. Early reports suggested a higher overall cost associ- ated with a laparoscopic approach for diverticular resection;

however, more recent studies (Table 50-4) have demonstrated a cost saving with the laparoscopic approach. This cost reduc- tion has been noted not only in the United States, but also in European countries. It should be noted that these are generally the elective uncomplicated cases with fewer patients present- ing with abscess or fistula formation. For more complex cases, in which the operative times are longer and the rate of conver- sion is higher, the cost savings benefit of a laparoscopic approach may be lost. This highlights the importance of case selection when considering a laparoscopic approach. Less- experienced surgeons should consider an early conversion of complicated diverticular resection or potentially an alteration in the approach to a hand-assisted technique in which the dif- ficult pelvic dissection can be guided by the hand laparoscop- ically or by conventional means through the open wound.⁷⁶

Rectal Prolapse

As with other disease processes, the field of laparoscopy has expanded to the treatment of rectal prolapse. Full-thickness rectal prolapse repaired by an abdominal fixation procedure is potentially an ideal procedure for a laparoscopic approach because there is no specimen to remove or anastomosis to cre- ate. There are many studies that have evaluated not only laparoscopic fixation procedures but also the combination of sigmoid resection and rectopexy for the treatment of rectal prolapse (Table 50-4).^77–98 The magnified view into the pelvis with the laparoscope provides unparalleled visualization into the pelvic floor and the relative laxity of the rectal fixation to the presacral area is beneficial to performance of a laparo- scopic procedure. This likely is the reason for the relatively low rate of conversion (<10%) for a laparoscopic rectopexy or resection and rectopexy in comparison to other laparoscopic colorectal procedures. The mobilization of the rectum for rec- tal prolapse is an ideal procedure in which to learn the laparo- scopic technique of rectal mobilization which may then be applied to other procedures such as laparoscopic proctocolec- tomy or total mesorectal excision for rectal cancer.

In addition to case series results, there have been several nonrandomized comparative studies of laparoscopic versus conventional rectopexy and resection rectopexy.^87,88,94 These studies showed a longer operative time of 45–60 minutes with the laparoscopic procedures but with a shortened length of stay of 2–3 days. Functional results after surgery were similar in laparoscopic and conventional groups, with the majority of patients reporting an improvement in incontinence and consti- pation. Solomon et al.⁹³ also reported a prospective, random- ized study of 40 patients with full-thickness rectal prolapse.

This was a well-designed study with the use of blinded

observers, and a standardized clinical pathway for both groups. As expected, the mean surgical time was 153 minutes in the laparoscopic group compared with 102 minutes in the open group (P < .01). In the laparoscopic group, however, 75%

of patients followed the clinical pathways as compared with only 37% of patients in the conventional group. The mean length of stay was also less (3.9 versus 6.6 days, P < .01) with 19/20 patients in the laparoscopic group discharged by post- operative day five as compared with 9/19 patients in the con- ventional group. There were no differences in postoperative pain scores but total intravenous narcotic usage was less in the laparoscopic group. Functional outcomes of surgery were equivalent, and there were no recurrences of prolapse in either group with a short mean follow-up of 24 months. Although the study is small in size, the outcomes mirror the results of other prospective, randomized studies of laparoscopic surgery for other diseases and procedures. A later cost analy- sis of this study demonstrated an overall mean cost savings of

$500 per patient in the laparoscopic group.⁹⁸

One of the major issues when discussing surgery for rectal prolapse is the rate of recurrent prolapse. For an abdominal approach, the risk of recurrence should be less than 5%–10%

over 5 years. Unfortunately, the majority of reports on laparo- scopic surgery for rectal prolapse have limited follow-up (less than 3 years). The reported rate of recurrence ranges from 0%

to 6% in these studies (Table 50-4). Recently, however, there have been two studies with a mean follow-up of 5 years.^95,97 In a study of 42 patients by D’Hoore et al.,⁹⁵with a mean fol- low-up of 61 months, the rate of recurrent prolapse was 4.8%.

In the largest study of laparoscopic surgery for rectal prolapse by Ashari et al.,⁹⁷with 117 patients over a 10-year period and a mean follow-up of 62 months, the rate of recurrent full- thickness prolapse was only 2.5%. The study, however, noted an 18% rate of mucosal prolapse, which is somewhat con- cerning. Further long-term follow-up of these patients is needed to ensure that the rate of recurrence remains accept- able. If the rate of recurrent prolapse is confirmed to occur at a rate equal to conventional surgery, a minimally invasive approach to rectal prolapse seems to be an ideal operation for surgeons with laparoscopic skills.

Colorectal Cancer

It is estimated that more than 105,500 new cases of colon cancer and 42,000 new cases of rectal cancer were diagnosed in the United States in 2003.⁹⁹Before 2004, fewer than 5%

of resections for colon and rectal cancer were being per- formed laparoscopically. Early in the history of laparoscopic resection of colorectal cancer there was controversy related to the phenomenon of cancer implants at incision sites. Data from randomized, controlled trials, however, have laid to rest these controversial aspects of the minimally invasive approach. The percentage of cases performed laparoscopi- cally is expected to increase, as more surgeons become familiar with these techniques.

TABLE50-4.Recent results of laparoscopy for rectal prolapse No. of Follow-upOperative time Recurrence StudyYearpatients(mo)Procedure(min) LR/LRRLOS (d)(%)Comment Poen etal.8319961219LR195100Improved continence Himpens etal.841999376–48LR130703% conversion Bruch etal.8619995730LR/LRR227/257150Constipation improved in 76% Boccasanta etal.87199910Compared with open—longer op time, lower cost, shorter LOS Xynos etal.88199910NSLRR1304.7NSCompared with open—longer op time, shorter LOS Kessler etal.8919993233LR/LRR1505FT 6.210% developed bowel obstruction Heah etal.9020002526LR967016% conversion Kellokumpu etal.9120003424LR/LRR150/25557Constipation improved in 70% Benoist etal.9220014820–47LR/LRR——MP 8Suture rectopexy preferred to mesh Solomon etal.9320022024LR1533.90Prospective, randomized study Kairaluoma etal.9420035312LR/LRR127/21056Compared with open—longer op time, shorter LOS D’Hoore etal.9520044261LRNSNSFT 4.8Constipation improved in 84% Lechaux etal.9620054836LR/LRR1934–7MP 4.2Constipation worsened in 23% Ashari etal.97200511762LRR110–1805FT 2.5; MP 18Large study with long-term follow-up RR, resection rectopexy; PFR, pelvic floor repair; AR, anterior resection; FRM, full rectal mobilization without fixation; LARR, laparoscopic resection rectopexy; LAR, laparoscopic rectopexy; FT, full thickness; MP, mucosal prolapse; NS, not specified.

Background

After the success of minimally invasive techniques for chole- cystectomy, reports of laparoscopic colon resections soon appeared.¹⁰⁰ Sadly, the specter of wound implants, or recur- rence of cancer in the laparoscopic incisions, followed shortly thereafter. In retrospect, it seems that in the attempt to allow patients to benefit from minimally invasive techniques, oper- ations for colon cancer were being attempted that did not ful- fill accepted oncologic principles, i.e., shortcuts were being taken with the extent of resection. Larger series by experi- enced surgeons showed that wound implants were not an inevitable accompaniment of the laparoscopic approach, but the damage was done. From 1994 to 2004 there was nearly a moratorium on laparoscopic resection for colon cancer, with some national surgical societies calling for these procedures to be performed only under the auspices of randomized, con- trolled trials or with other means of careful prospective data collection.¹⁰² These concerns prompted an unprecedented number of randomized, controlled trials4,5,20–24,102,103 and a new field of tumor and immunology investigation as they pertain to the pneumoperitoneum.

Lacy et al.¹⁰³ published the first large single-center ran- domized controlled trial in 2002. With median follow-up of 39 months, Lacy and his colleagues reported higher cancer- related survival for the laparoscopic arm. Specifically, they showed no difference between arms for Stage II cancers, but an improved survival for the laparoscopic approach in Stage III cancers where the outcome was similar to that of Stage II patients. This was followed in 2004 by the results of the large multicenter COST study group.²⁴ With almost 900 patients randomized either to the open or the laparoscopic arm of the study, no differences were found in overall survival or dis- ease-free survival. Further reassurance was provided in find- ing that there were only two wound recurrences in the laparoscopic group, and one in the open arm. Another of the large prospective randomized studies, the “CLASICC” trial from the United Kingdom, has also recently published results with similar findings except a higher rate of conversions was noted.⁴ The results of these recent trials (Table 50-5) have demonstrated that similar oncologic resections can be achieved by experienced surgeons performing laparoscopic colorectal resections.

Laparoscopic Resection of Colon and Rectal Cancer

The following description regarding the safe performance of laparoscopic resection for curable colon and rectal cancer is based on current literature and experience. The attention to technical detail is in response to the early concerns regarding oncologic outcomes. It is predicated on the understanding that patients with curable colon and rectal cancer are treated by

experienced surgeons whose minimally invasive skills fulfill the Credentialing Recommendations endorsed jointly by ASCRS (American Society of Colon and Rectal Surgeons) and SAGES (Society of American Gastrointestinal and Endoscopic Surgeons).^104,105

General Considerations

After detection of a colon or rectal cancer, routine evaluation incorporates preoperative staging, assessment of resectability, and determination of the patient’s operative risk. As part of this assessment, a laparoscopic approach may be contem- plated. There are several factors to consider, primarily in terms of gauging the difficulty of the procedure and the likelihood of being able to perform it laparoscopically. The site of the tumor is important, because right and sigmoid colectomy are gener- ally less technically demanding than, for example, low anterior resection. Documented extensive adhesions may preclude a minimally invasive approach, although laparoscopic resection is frequently possible in patients who have had prior abdomi- nal operations. Obesity, and particularly the distribution of abdominal fat, may preclude laparoscopic resection, especially in the case of a rectal cancer in an obese male patient with a narrow pelvis. The patient should be informed of both laparoscopic and open alternatives, and the possible need for conversion. Above all, the surgeon must have adequate expe- rience before embarking on resection for a potentially curable malignancy. Patients are increasingly sophisticated regarding their health care, and the surgeon must be prepared to answer questions about experience with the procedure.

Tumor Localization

The entire colon and rectum should be evaluated to eliminate synchronous lesions.^106,107 This is usually achieved with colonoscopy, but this has limitations in terms of localization, particularly if a minimally invasive approach is being consid- ered. Colonoscopy is most accurate for localization of a tumor in the rectum and cecum only. Lesions elsewhere in the colon may be inaccurately localized by colonoscopy in up to 14% of cases.¹⁰⁸A laparoscopic approach requires accurate localiza- tion of the tumor to a specific segment of the colon, because even a known cancer may not be visualized from the serosal aspect of the bowel during laparoscopy. The wrong segment of colon may be removed if accurate localization has not been performed.¹⁰⁹

A variety of other options is available to localize a lesion including preoperative colonoscopic marking with ink tattoo or metallic clips, barium enema, or intraoperative endoscopy. The area adjacent to a cancer or polyp may be marked either by endoscopic clips or submucosal india ink injection. If clips are placed, immediate abdominal X-rays films should be taken, otherwise intraoperative imaging with laparoscopic ultrasound

TABLE50-5. Prospective, randomized trials comparing laparoscopic and conventional surgery for colorectal cancer

Lacy et al. 2002¹⁰³ COST 2004²⁴ CLASICC 2005⁴

Baseline characteristics LAP versus OPEN LAP versus OPEN LAP versus OPEN

No. assigned 111:108 435:437 526:268

No. completed (dead or no data) 105:101 435:428 452:231

74:37

Age 68:71 70:69 69:69

Gender (F) 55:58 49%:51% 44%:46%

Previous surgery 40:47 43%:46%

Operative findings Procedure

Right 49:49 54%:54% 24%:24%

Left 4:1 7%:7% 7%:9%

Sigmoid 52:46 38%:38% 13%:12%

AR/LAR 3:9 37%:36%/12%:13%

Other 3:3 4%:3%

TNM stage

0 5%:8% Not given

I 27:18 35%:26%

II 42:48 31%:34%

III 37:36 26%:28%

IV 5:6 4%:2%

No. lymph nodes 11.1:11.1 12:12 12:13.5

Conversion 12 (11%):N/A 21%:N/A 29%:N/A

OR time (min) 142:118^* 150:95^* 180:135 (anesthesia time)

Incision length (cm) 6:18^* 10:22

Short-term outcomes

Oral intake (h) 54:85^*

(d) 6:6

Hospital stay (d) 5.2:7.9^* 5:6^* 9:11

30-d mortality <1%:1% 4%:5%

Postoperative complications 12:31^* 19%:19% 33%:32%

Colon Rectum

Wound infection 8:18 5%:5% 13%:12%

Pneumonia 0:0 7%:4% 10%:4%

Ileus 3:9

Leak 0:2 2%:0% 10%:7%

Duration of oral analgesics (d) 1:2^*

Duration of parenteral analgesics (d) 3:4^*

Cancer outcomes

Tumor recurrence 18:28 76:84

Distant 7:9

Locoregional 7:14

Peritoneal seedling 3:5

Port site 1:0 2:1

5-y overall survival† 82%:74% 79%:78%

I 85%:94% 84%:94%

II 75%:77% 78%:81%

III 72%:45% 60%:63%

5-y disease-free survival† 78%:80%

I 90%:88% 92%:96%

II 80%:76% 82%:88%

III 70%:45% 62%:60%

Cancer-related survival† 91%:79%^*

I 100%:99%

II 88%:85%

III 84%:50%^*

*Statistically significant difference.

†Extrapolated from graphs in manuscript.

or fluoroscopy is necessary to localize the clip’s location. This procedure is not frequently used because it requires an experi- enced radiologist and/or endoscopist. Preoperative endoscopic tattooing is a common method of tumor localization.^110,111India ink is a nonabsorbable marker that has been reported in more than 600 cases for tumor localization since 1975. The ink is injected into the submucosa in three or four quadrants around the lesion, or 2 cm distal to the lesion if the tumor is in the distal colon and distal margins are potentially an issue (typically 0.5 cc per site). During diagnostic laparoscopy, the ink marking can be identified even at the flexures or transverse colon. India ink injection seems to be safe with few reported complications.

Intraoperative endoscopy is hampered by persistent bowel dis- tention, prolongation of operative times, and need for equip- ment and endoscopist intraoperatively. More recent studies have evaluated CO₂colonoscopy which allows for more rapid absorption of the intracolonic gas which may facilitate its use during laparoscopic procedures.¹¹²

Preoperative Staging

Guidelines are available for standard practices in preoperative assessment for open resection of colon or rectal cancer.^113,114 There are additional considerations with a laparoscopic approach to ensure accurate staging of the liver. In patients with colorectal cancer, the liver should be thoroughly evaluated using computed tomography (CT) with intravenous contrast, ultrasound, or magnetic resonance imaging. Because of limita- tion in tactile sensation associated with laparoscopy, these stud- ies should be performed preoperatively. Alternatively, intraoperative laparoscopic ultrasonography offers the ability to fully evaluate the liver at the time of colorectal resection.

Several studies have confirmed the feasibility and efficacy of laparoscopic ultrasound in the evaluation of liver metastasis from colorectal cancer.^115–117 Preoperative CT or ultrasound was a requirement of the COST randomized, controlled trial.²⁴ No excess of Stage IV disease was noted in the laparoscopic arm, suggesting that routine preoperative evaluation of the liver was equivalent in terms of oncologic outcome to palpation of the liver intraoperatively in the open arm of the study.

These considerations do not apply to rectal cancer, where staging CT scan and transanal rectal ultrasound should be routine.^114,118Preoperative CT of the abdomen and pelvis, or hepatic ultrasound are routinely used in planning resection of rectal cancer, because the results may markedly alter the need for neoadjuvant therapy and the timing of the operative approach.

Preparation For Operation

Perioperative guidelines address the use of outpatient bowel preparation, prophylactic antibiotics, blood cross matching, and thromboembolism prophylaxis.¹⁰⁶None of these aspects

of patient care are affected by a laparoscopic approach, although some surgeons prefer to modify the bowel prepara- tion. Despite lack of clear evidence of benefit from meta- analysis¹¹⁹ and randomized, controlled trials,^120–124 a mechanical bowel preparation is frequently used in North America. Aside from the aesthetic aspects, an empty colon facilitates manipulation of the bowel with laparoscopic instruments. Use of large-volume mechanical bowel prepara- tions may occasionally leave fluid-filled loops of small bowel that are more difficult to handle with laparoscopic instruments. A smaller-volume preparation may be used or the large-volume preparation may be followed by use of lax- atives such as bisacodyl to reduce the volume of residual fluid. Some surgeons use 2- to 3-day periods of preparation rather than the usual 24 hours, especially if a completely laparoscopic approach and intracorporeal anastomosis is contemplated.¹²⁵

Operative Issues

Certain operative principles pertain specifically either to the colon or to the rectum. Other issues are relevant to both.

Operative Techniques—Colon

Oncologic principles must not be compromised by a laparo- scopic resection for colon cancer. Guidelines for colon can- cer surgery outline recommendations for proximal and distal resection margins (based on the area supplied by the named feeding arterial vessel); mesenteric lymphadenectomy con- taining a minimum of 12 lymph nodes; and ligation of the primary feeding vessel at its base.¹²⁶The randomized trials of laparoscopic colectomy adhered to these standard prin- ciples^4,24,103 and showed no significant difference in bowel margins, lymph nodes harvested, and, in the COST study, perpendicular length of the mesentery (a guide to the length of the vascular pedicle).²⁴ Inability to achieve these aims laparoscopically should prompt conversion to an open procedure.

These principles guide which steps of a procedure per- formed for cancer may be completed intracorporeally or extracorporeally. In the individual with a normal body mass index (BMI) undergoing right colectomy, it may be possible to divide the origin of the ileocolic pedicle extracorporeally using a small periumbilical extraction incision which over- lies the base of the pedicle, and achieve an oncologically correct proximal ligation; intracorporeal ligation is obvi- ously also an acceptable approach. In patients with BMI

> 25, this ligation should be performed intracorporeally to ensure that the base of the pedicle is ligated. Intracorporeal ligation is required for proximal division of all other vessels unless a larger incision such as used for hand-assisted devices permits access via the incision to the origin of the vascular pedicle.