- Email: [email protected]
Laparoscopic colorectal surgery in the complicated patient
The American Journal of Surgery 190 (2005) 891– 895
Papers presented
Laparoscopic colorectal surgery in the complicated patient Margaret D. Plocek, M.D., Daniel P. Geisler, M.D.*, Edward J. Glennon, M.D., Phillip Kondylis, M.D., John C. Reilly, M.D. Section of Colorectal Surgery, St. Vincent Health System, Erie, PA, USA Manuscript received April 11, 2005; revised manuscript August 8, 2005 Presented at the 57th Annual Meeting of the Southwestern Surgical Congress, San Antonio, Texas, April 10 –12, 2005
Abstract Background: Major comorbidities are recognized risk factors in colorectal surgery. We examine here the feasibility and safety of laparoscopic colorectal surgery (LC) in the complicated, high-risk patient. Methods: From July 2003 to October 2004, 107 consecutive patients undergoing LC were prospectively studied. Complicated patients were defined as age ⬎80 years, body mass index (BMI) ⬎30, and/or American Society of Anesthesiology level III or IV. A group of case-matched controls undergoing open surgery (OC) during a similar time period were retrospectively reviewed. The 2 groups were compared and assessed for major and minor morbidity and mortality. Results: Overall morbidity was higher in the OC group 52% versus 26%. Minor complications compared at 31% OC versus 9% LC and major at 21% and 17%, respectively. With LC, advancement to discharge was more rapid and discharge home more likely than to a care facility. Conclusion: With proper patient selection and laparoscopic experience, LC can be performed in the complicated patient without undue morbidity and mortality. © 2005 Excerpta Medica Inc. All rights reserved. Keywords: Laparoscopic colectomy; Complicated; High risk; Outcomes; Morbidity; Colorectal surgery
Major comorbidities are recognized risk factors for perioperative morbidity and mortality in conventional colorectal surgery [1–3]. The last decade has witnessed the application of minimally invasive techniques to increasingly complex colon and rectal resections in increasingly fragile patients. Morbidity and mortality after colectomy have been most strongly associated with several risk factors, including American Society of Anesthesiology (ASA) level III or IV [2,4], age ⱖ80 years [5– 8], and body mass index (BMI) ⱖ30 [9]. Many studies have found laparoscopic colorectal resection to be safe in the elderly [10 – 12] and feasible in the obese [9,13]. There are, however, no published studies comparing outcomes after laparoscopic colectomy (LC) and open colectomy (OC) in a matched series of high-risk patients defined by the 3 factors noted above. Our study was designed to permit that comparison and to determine the contribution of individual risk factors to differences in morbidity and mortality in the 2 groups.
* Corresponding author. 9500 Euclid Avenue, Cleveland, OH 44195. Tel.: ⫹1-216-445-7616; fax: ⫹1-216-445-8627. E-mail address: [email protected]
Materials and Methods As part of an ongoing project beginning in July 2003, data relative to all laparoscopic colorectal procedures performed by a single surgeon (D.G.) have been recorded in an investigational review board-approved prospective database. Between July 2003 and October 2004, 107 laparoscopic colorectal procedures were performed. Seventy parameters relative to patient demographics, preoperative diagnosis, intraoperative events, postoperative course, and follow-up were documented on a standardized form for each patient. High-risk patients were defined as any patient with an age ⱖ80, BMI ⱖ30, and/or an ASA of III or IV. All data were prospectively recorded and serves as the basis of this retrospective analysis in accordance to intraoperative issues, perioperative events, and type of surgery performed. Patients with emergency operations or undergoing simple diversion were excluded from this study. Analysis was also performed between patients undergoing a laparoscopic colorectal resection and a control group of equally matched patients undergoing an open resective procedure.
0002-9610/05/$ – see front matter © 2005 Excerpta Medica Inc. All rights reserved. doi:10.1016/j.amjsurg.2005.08.014
892
M.D. Plocek et al. / The American Journal of Surgery 190 (2005) 891– 895
The control group of open colorectal resective patients undergoing surgery during the same time frame was studied retrospectively and matched by age, BMI, ASA classification, and type of surgery. Information collected in the control group was coordinated to include all preoperative, intraoperative, and postoperative data that had been prospectively collected in the laparoscopic cohort. Feasibility was measured on the basis of conversion rate in the laparoscopic group with comparisons of perioperative events and overall morbidity and mortality serving as measurements of comparison in the 2 equally matched groups. Between July 2003 and October 2004, 66 high-risk patients, 34 men and 32 women, underwent laparoscopic colorectal resective surgery. The case-matched control group of consecutive high-risk patients undergoing open colectomy during a similar time period numbered 67, 30 men and 37 women. For the purpose of statistical analysis, procedures were grouped into “proximal” and “distal” colectomy depending on the relationship of the resection to the splenic flexure. Operative mortality was defined as death within 30 days of surgery; morbidity was defined as a complication requiring additional treatment or prolonged hospital stay. Morbidities were divided into 2 groups, designated “major” or “minor.” Major morbidity included anastomotic leak, anastomotic stricture, internal hernia, fascial dehiscence with evisceration, myocardial infarction, pulmonary embolus, arrhythmia, respiratory failure requiring intubation, acute renal failure, cerebrovascular accident or any condition requiring intensive care unit management. Minor complications included transient partial small bowel obstruction, ileus, minor anastomotic bleeding, wound infection, wound hematoma, hernia, urinary retention, urinary tract infection, anal fissure, seizure, Clostridium difficile colitis, and pneumonia without major respiratory compromise. In the cases of multiple complications in a single patient, only the most serious morbidity was recorded. Conversion to a laparoscopic-assisted procedure was defined as complete laparoscopic colon mobilization and vessel ligation with completion of the pelvic dissection through a Pfannensteil incision. Conversion to an open operation was defined as completion of the operation through a midline laparotomy incision.
Table 2 Indications for surgery
Diverticulitis Rectal cancer Colon cancer IBD Benign polyp FAP Benign colonic stricture Colonic inertia
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
9 15 27 1 12 0 1 1
9 15 34 1 6 1 1 0
FAP ⫽ familial adenomatous polyposis; IBD ⫽ inflammatory bowel disease.
All cases were analyzed and compared with regards to hospital course, mortality, and major and minor morbidities in the context of preoperative comorbidities. Progression of diet and early ambulation were dictated by the institutions surgical care pathway with both groups of patients sharing the same postoperative care pathway. Professional statistical analysis was performed employing SPSS version 12.0 (Chicago, IL). Results are reported as mean (⫾SD) with a P value ⱕ.05 considered significant. Differences between the 2 groups were analyzed by the utilization of Pearson’s chi-square test while logistic regression analysis was employed to test for differences between age, BMI, ASA classification, and outcome variables related to perioperative morbidity and mortality.
Results The classification of high-risk patients is shown in Table 1 with no significant differences between the laparoscopic and open groups. There were also no significant differences between the 2 groups in relations to the indications for surgery (Table 2) or the operative procedures performed (Table 3). In the laparoscopic group (LC), 92% (n ⫽ 61) of cases Table 3 Procedures performed
Table 1 Classification of high-risk patients
Elderly (age ⱖ80) Obese (BMI ⱖ30) ASA III or IV Multiple Age* BMI* ASA*
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
P
17 27 53 29 69 (33–92) 28 (18–54) III (II–IV)
20 33 48 30 72 (37–95) 28 (19–39) III (I–IV)
ⱖ.478 ⱖ.478 .549 .999 ⱖ.478 ⱖ.478 .549
* Mean (range). BMI ⫽ Body mass index.
Right hemicolectomy Left hemicolectomy Low anterior resection Total abdominal colectomy Radical proctosigmoidectomy and coloanal anastomosis APR IPAA TPC
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
29 14 15 3 2
29 13 17 3 4
1 1 1
1 0 0
APR ⫽ abdominoperineal resection; IPAA ⫽ panproctocolectomy with ileo-pouch anal anastomosis; TPC ⫽ total proctocolectomy with end ileostomy.
M.D. Plocek et al. / The American Journal of Surgery 190 (2005) 891– 895 Table 4 Complications in all patients
Major Anastomotic complication Internal hernia Dehiscence MI Arrhythmia ARF CVA PE Respiratory failure Minor PSBO Ileus Minor anastomotic bleed Wound infection Wound hematoma Hernia Urinary retention UTI Pneumonia Seizure C difficile colitis Anal fissure
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
P
11 4
14 1
.658
1 1 0 2 0 0 0 0 6 0 1 0
0 0 2 3 1 1 1 2 21 3 0 1
3 0 0 0 0 2 0 0 0
5 1 2 1 3 2 1 1 1
.002
893
was statistically significant (P ⫽ .002). In multivariate analysis, this difference was independent of patient age, BMI, or ASA classification (P ⬎ .05) and attributable only to the use of a minimally invasive approach (P ⫽ .002). Complications are shown in Table 4. Minor complications were more likely to occur in the OC group, with an incidence of minor morbidity of 9% in the LC group compared to 31% in the OC group (P ⫽ .002). There was also a trend for decreased major morbidity in the LC group, 17% versus 21%, although this did not reach statistical significance (P ⫽ .658). All parameters of hospital course were significantly better in the LC group, including time to flatus (P ⬍ .001), time to bowel movement (P ⬍ .001), tolerance of a clear liquid diet (P ⫽ .004), tolerance of a house diet (P ⫽ .003), and time to discharge (P ⫽ .017) (Table 5). These differences were not statistically linked to covariates of “high-risk” including ASA classification, advanced age, BMI (P ⱖ .151) or type of surgery performed, proximal or distal (P ⫽ .678). For those patients not previously in such a facility, the need for placement in a rehabilitation or skilled nursing facility was significantly higher in the OC group, 13% (n ⫽ 9) versus 2% (n ⫽ 1) (P ⫽ .017).
ⴱ
Some patients had multiple complications. ARF ⫽ acute renal failure; CVA ⫽ cerebrovascular accident; MI ⫽ myocardial infarction; PE ⫽ pulmonary embolus; PSBO ⫽ partial small bowel obstruction; UTI ⫽ urinary tract infection.
were completed laparoscopically, 5% (n ⫽ 3) were completed using a laparoscopic-assisted technique, and 3% (n ⫽ 2) were converted to open. Conversion to a laparoscopic-assisted procedure was for the following: poor visualization in a patient with a BMI of 40, unclear anatomy in a patient with a peri-diverticular abscess (n ⫽ 1), and large diverticular phlegmon (n ⫽ 1); while reasons for conversion to an open procedure were for failure to progress with prior high-dose pelvic radiation (n ⫽ 1) and unresectability of a T4 sigmoid carcinoma encasing the iliac vessels (n ⫽ 1). The median size of the specimen extraction site was 5.7 cm (range 1.6 to 14 cm). All procedures were performed with 3 (n ⫽ 52) or 4 trocars (n ⫽ 14). Increased age, obesity, ASA classification, type of surgery performed, and length of operation were independent variables and did not influence patient outcome with regards to perioperative events, morbidity, or mortality. In the overall group of 133 patients, there was 1 perioperative death from postoperative respiratory failure and pneumonia leading to tracheostomy and, ultimately, to withdrawal of life support. This mortality occurred in the open colectomy group (OC). The difference in mortality between the OC and LC groups, however, was not statistically significant (P ⫽ .999). The overall incidence of morbidity was higher in the OC group than the LC group, 52% versus 26%. This difference
Comments Surgery in elderly, obese, and high-risk patients (ASA III or IV) is associated with higher rates of perioperative mortality and morbidity [1–3]. Nearly 40% of elderly patients undergoing open colorectal surgery present with multiple comorbidities and surgeons are being asked to perform resections on increasingly complex cases [4,5,7]. Morbid obesity represents an increasingly prevalent comorbidity. This patient subset demonstrates an increased rate of cardiac, pulmonary, anastomotic, and wound complications, as well as increased operative mortality and prolonged hospital stay. Although minimally invasive surgery is associated with an overall decreased operative morbidity, the laparoscopic approach is often overlooked in patients with multiple medical problems as they are Table 5 Hospital course in all patients
Clears* House diet* Flatus* Bowel movement* Discharge* Home† Extended-care facility† * Mean in days. † Number.
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
P
3 5 2 3 6 65 1
4 6 5 6 8 58 9
.004 .003 ⬍.0001 ⬍.0001 .017 .017
894
M.D. Plocek et al. / The American Journal of Surgery 190 (2005) 891– 895
felt, paradoxically, to be too “high-risk” for a minimally invasive approach. Several studies have reported that laparoscopic colorectal surgery is safe and feasible and is associated with increased patient satisfaction [13–15]. Our conversion rate of 8% to an open procedure or to a laparoscopicassisted procedure is higher than that in our overall patient population (5%) but compares favorably with what is reported in the literature in this patient subset [9,10,13,16]. The learning curve associated with the performance of an advanced laparoscopic colorectal procedure contributes to patient outcome and has been well documented [17]. The results of the Clinical Outcomes of Surgical Therapy Study Group (COST) trial have proven that laparoscopic colorectal surgery is an acceptable alternative to open surgery for colon cancer when performed by surgeons who have demonstrated appropriate laparoscopic experience and oncologic expertise [18]. Our study was designed to compare outcomes after laparoscopic and open colectomy in a case-matched series of high-risk patients. Our data demonstrated that a laparoscopic approach compares favorably to an open approach in this high-risk subset with regard to perioperative mortality and morbidity. There was no mortality in the LC group. Overall morbidity was significantly lower in the LC group (26%) compared to the OC group (52%). This difference was driven by a substantial reduction in minor complications after minimally invasive surgery. The specific comorbidity, the type of resection performed (proximal vs distal colon) and the length of the procedure were independent variables that did not influence patient outcome with regard to perioperative events, morbidity, or mortality. Differences in morbidity were attributable only to the utilization of a minimally invasive approach. Our results compare favorably with literature reports of a 22% to 79% incidence of overall morbidity, 11% to 29% incidence of minor morbidity, 21% to 28% incidence of major morbidity, and a 0% to 19% mortality rate in this high-risk subset of patients undergoing open colectomy [10,11,19]. The decrease in overall morbidity in the LC group was accompanied by a significant improvement in time to return of bowel function, tolerance of house diet, and hospital discharge. Patients treated laparoscopically were also more likely to be discharged home instead of to an extended care facility or nursing home, as is all to often the case [11,16,20]. This personal experience with laparoscopic colorectal surgery in the high-risk patient suggests that advanced age, obesity, and high ASA classification are not contraindications to a minimally invasive approach. Surgery on this high-risk population is not associated with exceptional mortality or morbidity. This subset of patients seems to fair better when treated laparoscopically as compared to an equally matched group of high-risk patients undergoing open colon resection.
Acknowledgment The authors would like to thank Tim Cooney for his assistance in the statistical analysis and Ron Plocek for participation in formulation of the manuscript.
References [1] Fazio VW, Tekkis PP, Remzi F, et al. Assessment of operative risk in colorectal cancer surgery: the Cleveland Clinic Foundation colorectal cancer model. Dis Colon Rectum 2004;47:2015–24. [2] Longo WE, Virgo KS, Johnson FE, et al. Risk factors for morbidity and mortality after colectomy for colon cancer. Dis Colon Rectum 2000;43:83–91. [3] Ondrulla DP, Nelson RL, Prasad ML, et al. Multifactorial index of preoperative risk factors in colon resections. Dis Colon Rectum 1992; 35:117–22. [4] Leung JM, Dzankic S. Relative importance of preoperative health status versus intraoperative factors in predicting postoperative adverse outcomes in geriatric surgical patients. J Am Geriatr Soc 2001; 49:1080 –5. [5] Liu LI, Leung JM. Predicting adverse postoperative outcomes in patients aged 80 years or older. J Am Geriatr Soc 2000;48:405–12. [6] Spivak H, Maele DV, Friedman IL, et al. Colorectal surgery in octogenarians. J Am Coll Surg 1996;183:46 –50. [7] Zenilman ME, Surgery in the elderly. Curr Probl Surg 1998;35:99 – 179. [8] Arozullah AM, Daley J, Hendersend WG, et al. Multifactorial risk index of predicting postoperative respiratory failure in men after major noncardiac surgery. Ann Surg 2000;232:242–53. [9] Pikarsky AJ, Saida Y, Yamaguchi T. Is obesity a high-risk factor for laparoscopic colorectal surgery? Surg Endosc 2002;16:855– 8. [10] Law WL, Chu KW, Tung PHM. Laparoscopic colorectal resections: a safe option for elderly patients. J Am Coll Surg 2002;195:768 –73. [11] Sklow B, Read T, Birnbaum E, et al. Age and type of procedure influence the choice of patients for laparoscopic colectomy. Surg Endosc 2003;17:923–9. [12] Tuech JJ, Pessauz P, Rouge C, et al. Laparoscopic vs open colectomy for sigmoid diverticulitis: a prospective comparative study in the elderly. Surg Endosc 2000;14:1031–3. [13] Senagore AJ, Delaney CP, Madboulay K, et al. Laparoscopic colectomy in obese and nonobese patients. J Gastrointest Surg 2003;7: 558 – 61. [14] Guller U, Jain N, Hervey S, et al. Laparoscopic vs open colectomy; outcomes comparison based on large nationwide databases. Arch Surg 2003;138:1179 – 86. [15] Velanovich. V. Laparoscopic vs open surgery; a preliminary comparison of quality-of-life outcomes. Surg Endosc 2000;14:16 –21. [16] Stocchi L, Nelson H, Young-Fadok TM, et al. Safety and advantages of laparoscopic vs. open colectomy in the elderly. Dis Colon Rectum 2000;43:326 –32. [17] Reissman P, Cohen S, Weiss EG, et al. Laparoscopic colorectal surgery: ascending the learning curve. World J Surg 1996;20:277– 82. [18] Delgado S, Lacy AM, Garcia Valdecasas, et al. Could age be an indication for laparoscopic colectomy in colorectal cancer? Surg Endosc 2000;14:22– 6. [19] Stewart BT, Stitz RW, Lumley JW. Laparoscopically assisted colorectal surgery in the elderly. Br J Surg 1999;86:938 – 41. [20] Nelson H, Sargent DJ, Weiand HS, et al. A comparison of laparoscopically assisted and open colectomy for colon cancer; the Clinical Outcomes of Surgical Therapy Study Group. N Engl J Med 2004; 350:2050 –9.
M.D. Plocek et al. / The American Journal of Surgery 190 (2005) 891– 895
Discussion Erik Wilson, M.D. (Houston, Texas): This study shows a large morbidity advantage for laparoscopic colectomy in high-risk patients. It adds to the published data from randomized trials showing the equivalency or superiority of laparoscopic colectomy. It also supports my bias as a laparoscopic surgeon that a laparoscopic approach is the future of colon surgery. My questions are as follows: While your major complication rate is statistically the same for both the laparoscopic and the open groups, the anastomotic complication rate appeared to be slightly higher. In your laparoscopic arm you had 4 anastomotic complications, and in your open arm you had 1 anastomotic complication. That may not be a statistically significant difference, but with larger numbers of study patients, it certainly could be different. Do you have a reason why that was? Was there a difference in your anastomotic technique comparing laparoscopic versus open? Was there a difference between right and left colons? The other question is, do you think laparoscopic colectomy is now standard care? If you do not, when is it going to become standard of care in your mind? What does it take to become standard of care? Lastly, since currently colon surgery is still performed laparoscopically only in a minority of patients, what is it going to take to train general surgeons and colorectal surgeons to perform this procedure at the volume it probably should be performed at? Daniel P. Geisler, M.D.: There are a number of laparoscopic series that show a slightly elevated incidence of anastomotic complications. In our series in this complex subset of patients, this was not statistically significant. However, there did appear to be a trend for an increased incidence of anastomotic complications in our series. All anastomotic complications in our series occurred in the first quarter of the study and can be attributed to technical issues that have been resolved. I do not believe increased tension is an issue in properly performed cases as I routinely take down the splenic flexure to allow for a tension-free anastomosis. In the past 100 or so cases, we have not had any anastomotic complications. In regards to standard of care, I think that may come quicker than many think. If you pooled all colorectal sur-
895
geons, you would find about 5% of colon resections were being done laparoscopically. The initial hope was that in the next 10 years that number would triple or quadruple, which means only 15% to 20% of all resections be performed laparoscopically. However, I think that it may take off a lot quicker than that. We have seen significant growth in our community as the demand for a minimally invasive approach by both patients and referring doctors has been quite strong. Over the past 2 years, the percent of colorectal resections done laparoscopically in our community has grown from less than 1% to 38% of all cases. This included all procedures performed by general and colorectal surgeons, so it is increasing rather quickly. Proper training obviously can expedite the learning curve and must remain at the forefront of the laparoscopic movement. I do go out of my way to train the resident to be sure that they’re comfortable performing this operation, realize that the same strict surgical principles pertain to laparoscopic surgery as they do to open procedures, and to convert to an open operation if there is any question. The residents that we are now training all appear comfortable going out into practice, and I think that this will become the norm more and more across the United States. Erik Wilson, M.D.: It looked to me like 5% of your cases were lap-assisted, which would represent 3 cases out of the series. Does that mean that your right colons (which appeared to be more than 3 cases) were actually done with intracorporeal anastomoses, or did you do extracorporeal anastomoses on those? Daniel P. Geisler, M.D.: On the right colons, I do a periumbilical incision that typically measures between 4 and a half, and 5 and a half centimeters. That’s the specimen extraction site with the anastomosis being performed extracorporeally with a GIA and TA stapler. I qualify a laparoscopic-assisted procedure as one in which the transection of the bowel as well as the anastomosis is performed extracorporeal after the vessels have been taken intracorporeally. Erik Wilson, M.D.: So you don’t count the right colons as lap-assisted, you count those completely laparoscopic? Daniel P. Geisler, M.D.: Yes. Even though it’s not truly an intracorporeal anastomosis, an incision of 4 and a half centimeters, I qualify as a laparoscopic procedure.
Papers presented
Laparoscopic colorectal surgery in the complicated patient Margaret D. Plocek, M.D., Daniel P. Geisler, M.D.*, Edward J. Glennon, M.D., Phillip Kondylis, M.D., John C. Reilly, M.D. Section of Colorectal Surgery, St. Vincent Health System, Erie, PA, USA Manuscript received April 11, 2005; revised manuscript August 8, 2005 Presented at the 57th Annual Meeting of the Southwestern Surgical Congress, San Antonio, Texas, April 10 –12, 2005
Abstract Background: Major comorbidities are recognized risk factors in colorectal surgery. We examine here the feasibility and safety of laparoscopic colorectal surgery (LC) in the complicated, high-risk patient. Methods: From July 2003 to October 2004, 107 consecutive patients undergoing LC were prospectively studied. Complicated patients were defined as age ⬎80 years, body mass index (BMI) ⬎30, and/or American Society of Anesthesiology level III or IV. A group of case-matched controls undergoing open surgery (OC) during a similar time period were retrospectively reviewed. The 2 groups were compared and assessed for major and minor morbidity and mortality. Results: Overall morbidity was higher in the OC group 52% versus 26%. Minor complications compared at 31% OC versus 9% LC and major at 21% and 17%, respectively. With LC, advancement to discharge was more rapid and discharge home more likely than to a care facility. Conclusion: With proper patient selection and laparoscopic experience, LC can be performed in the complicated patient without undue morbidity and mortality. © 2005 Excerpta Medica Inc. All rights reserved. Keywords: Laparoscopic colectomy; Complicated; High risk; Outcomes; Morbidity; Colorectal surgery
Major comorbidities are recognized risk factors for perioperative morbidity and mortality in conventional colorectal surgery [1–3]. The last decade has witnessed the application of minimally invasive techniques to increasingly complex colon and rectal resections in increasingly fragile patients. Morbidity and mortality after colectomy have been most strongly associated with several risk factors, including American Society of Anesthesiology (ASA) level III or IV [2,4], age ⱖ80 years [5– 8], and body mass index (BMI) ⱖ30 [9]. Many studies have found laparoscopic colorectal resection to be safe in the elderly [10 – 12] and feasible in the obese [9,13]. There are, however, no published studies comparing outcomes after laparoscopic colectomy (LC) and open colectomy (OC) in a matched series of high-risk patients defined by the 3 factors noted above. Our study was designed to permit that comparison and to determine the contribution of individual risk factors to differences in morbidity and mortality in the 2 groups.
* Corresponding author. 9500 Euclid Avenue, Cleveland, OH 44195. Tel.: ⫹1-216-445-7616; fax: ⫹1-216-445-8627. E-mail address: [email protected]
Materials and Methods As part of an ongoing project beginning in July 2003, data relative to all laparoscopic colorectal procedures performed by a single surgeon (D.G.) have been recorded in an investigational review board-approved prospective database. Between July 2003 and October 2004, 107 laparoscopic colorectal procedures were performed. Seventy parameters relative to patient demographics, preoperative diagnosis, intraoperative events, postoperative course, and follow-up were documented on a standardized form for each patient. High-risk patients were defined as any patient with an age ⱖ80, BMI ⱖ30, and/or an ASA of III or IV. All data were prospectively recorded and serves as the basis of this retrospective analysis in accordance to intraoperative issues, perioperative events, and type of surgery performed. Patients with emergency operations or undergoing simple diversion were excluded from this study. Analysis was also performed between patients undergoing a laparoscopic colorectal resection and a control group of equally matched patients undergoing an open resective procedure.
0002-9610/05/$ – see front matter © 2005 Excerpta Medica Inc. All rights reserved. doi:10.1016/j.amjsurg.2005.08.014
892
M.D. Plocek et al. / The American Journal of Surgery 190 (2005) 891– 895
The control group of open colorectal resective patients undergoing surgery during the same time frame was studied retrospectively and matched by age, BMI, ASA classification, and type of surgery. Information collected in the control group was coordinated to include all preoperative, intraoperative, and postoperative data that had been prospectively collected in the laparoscopic cohort. Feasibility was measured on the basis of conversion rate in the laparoscopic group with comparisons of perioperative events and overall morbidity and mortality serving as measurements of comparison in the 2 equally matched groups. Between July 2003 and October 2004, 66 high-risk patients, 34 men and 32 women, underwent laparoscopic colorectal resective surgery. The case-matched control group of consecutive high-risk patients undergoing open colectomy during a similar time period numbered 67, 30 men and 37 women. For the purpose of statistical analysis, procedures were grouped into “proximal” and “distal” colectomy depending on the relationship of the resection to the splenic flexure. Operative mortality was defined as death within 30 days of surgery; morbidity was defined as a complication requiring additional treatment or prolonged hospital stay. Morbidities were divided into 2 groups, designated “major” or “minor.” Major morbidity included anastomotic leak, anastomotic stricture, internal hernia, fascial dehiscence with evisceration, myocardial infarction, pulmonary embolus, arrhythmia, respiratory failure requiring intubation, acute renal failure, cerebrovascular accident or any condition requiring intensive care unit management. Minor complications included transient partial small bowel obstruction, ileus, minor anastomotic bleeding, wound infection, wound hematoma, hernia, urinary retention, urinary tract infection, anal fissure, seizure, Clostridium difficile colitis, and pneumonia without major respiratory compromise. In the cases of multiple complications in a single patient, only the most serious morbidity was recorded. Conversion to a laparoscopic-assisted procedure was defined as complete laparoscopic colon mobilization and vessel ligation with completion of the pelvic dissection through a Pfannensteil incision. Conversion to an open operation was defined as completion of the operation through a midline laparotomy incision.
Table 2 Indications for surgery
Diverticulitis Rectal cancer Colon cancer IBD Benign polyp FAP Benign colonic stricture Colonic inertia
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
9 15 27 1 12 0 1 1
9 15 34 1 6 1 1 0
FAP ⫽ familial adenomatous polyposis; IBD ⫽ inflammatory bowel disease.
All cases were analyzed and compared with regards to hospital course, mortality, and major and minor morbidities in the context of preoperative comorbidities. Progression of diet and early ambulation were dictated by the institutions surgical care pathway with both groups of patients sharing the same postoperative care pathway. Professional statistical analysis was performed employing SPSS version 12.0 (Chicago, IL). Results are reported as mean (⫾SD) with a P value ⱕ.05 considered significant. Differences between the 2 groups were analyzed by the utilization of Pearson’s chi-square test while logistic regression analysis was employed to test for differences between age, BMI, ASA classification, and outcome variables related to perioperative morbidity and mortality.
Results The classification of high-risk patients is shown in Table 1 with no significant differences between the laparoscopic and open groups. There were also no significant differences between the 2 groups in relations to the indications for surgery (Table 2) or the operative procedures performed (Table 3). In the laparoscopic group (LC), 92% (n ⫽ 61) of cases Table 3 Procedures performed
Table 1 Classification of high-risk patients
Elderly (age ⱖ80) Obese (BMI ⱖ30) ASA III or IV Multiple Age* BMI* ASA*
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
P
17 27 53 29 69 (33–92) 28 (18–54) III (II–IV)
20 33 48 30 72 (37–95) 28 (19–39) III (I–IV)
ⱖ.478 ⱖ.478 .549 .999 ⱖ.478 ⱖ.478 .549
* Mean (range). BMI ⫽ Body mass index.
Right hemicolectomy Left hemicolectomy Low anterior resection Total abdominal colectomy Radical proctosigmoidectomy and coloanal anastomosis APR IPAA TPC
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
29 14 15 3 2
29 13 17 3 4
1 1 1
1 0 0
APR ⫽ abdominoperineal resection; IPAA ⫽ panproctocolectomy with ileo-pouch anal anastomosis; TPC ⫽ total proctocolectomy with end ileostomy.
M.D. Plocek et al. / The American Journal of Surgery 190 (2005) 891– 895 Table 4 Complications in all patients
Major Anastomotic complication Internal hernia Dehiscence MI Arrhythmia ARF CVA PE Respiratory failure Minor PSBO Ileus Minor anastomotic bleed Wound infection Wound hematoma Hernia Urinary retention UTI Pneumonia Seizure C difficile colitis Anal fissure
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
P
11 4
14 1
.658
1 1 0 2 0 0 0 0 6 0 1 0
0 0 2 3 1 1 1 2 21 3 0 1
3 0 0 0 0 2 0 0 0
5 1 2 1 3 2 1 1 1
.002
893
was statistically significant (P ⫽ .002). In multivariate analysis, this difference was independent of patient age, BMI, or ASA classification (P ⬎ .05) and attributable only to the use of a minimally invasive approach (P ⫽ .002). Complications are shown in Table 4. Minor complications were more likely to occur in the OC group, with an incidence of minor morbidity of 9% in the LC group compared to 31% in the OC group (P ⫽ .002). There was also a trend for decreased major morbidity in the LC group, 17% versus 21%, although this did not reach statistical significance (P ⫽ .658). All parameters of hospital course were significantly better in the LC group, including time to flatus (P ⬍ .001), time to bowel movement (P ⬍ .001), tolerance of a clear liquid diet (P ⫽ .004), tolerance of a house diet (P ⫽ .003), and time to discharge (P ⫽ .017) (Table 5). These differences were not statistically linked to covariates of “high-risk” including ASA classification, advanced age, BMI (P ⱖ .151) or type of surgery performed, proximal or distal (P ⫽ .678). For those patients not previously in such a facility, the need for placement in a rehabilitation or skilled nursing facility was significantly higher in the OC group, 13% (n ⫽ 9) versus 2% (n ⫽ 1) (P ⫽ .017).
ⴱ
Some patients had multiple complications. ARF ⫽ acute renal failure; CVA ⫽ cerebrovascular accident; MI ⫽ myocardial infarction; PE ⫽ pulmonary embolus; PSBO ⫽ partial small bowel obstruction; UTI ⫽ urinary tract infection.
were completed laparoscopically, 5% (n ⫽ 3) were completed using a laparoscopic-assisted technique, and 3% (n ⫽ 2) were converted to open. Conversion to a laparoscopic-assisted procedure was for the following: poor visualization in a patient with a BMI of 40, unclear anatomy in a patient with a peri-diverticular abscess (n ⫽ 1), and large diverticular phlegmon (n ⫽ 1); while reasons for conversion to an open procedure were for failure to progress with prior high-dose pelvic radiation (n ⫽ 1) and unresectability of a T4 sigmoid carcinoma encasing the iliac vessels (n ⫽ 1). The median size of the specimen extraction site was 5.7 cm (range 1.6 to 14 cm). All procedures were performed with 3 (n ⫽ 52) or 4 trocars (n ⫽ 14). Increased age, obesity, ASA classification, type of surgery performed, and length of operation were independent variables and did not influence patient outcome with regards to perioperative events, morbidity, or mortality. In the overall group of 133 patients, there was 1 perioperative death from postoperative respiratory failure and pneumonia leading to tracheostomy and, ultimately, to withdrawal of life support. This mortality occurred in the open colectomy group (OC). The difference in mortality between the OC and LC groups, however, was not statistically significant (P ⫽ .999). The overall incidence of morbidity was higher in the OC group than the LC group, 52% versus 26%. This difference
Comments Surgery in elderly, obese, and high-risk patients (ASA III or IV) is associated with higher rates of perioperative mortality and morbidity [1–3]. Nearly 40% of elderly patients undergoing open colorectal surgery present with multiple comorbidities and surgeons are being asked to perform resections on increasingly complex cases [4,5,7]. Morbid obesity represents an increasingly prevalent comorbidity. This patient subset demonstrates an increased rate of cardiac, pulmonary, anastomotic, and wound complications, as well as increased operative mortality and prolonged hospital stay. Although minimally invasive surgery is associated with an overall decreased operative morbidity, the laparoscopic approach is often overlooked in patients with multiple medical problems as they are Table 5 Hospital course in all patients
Clears* House diet* Flatus* Bowel movement* Discharge* Home† Extended-care facility† * Mean in days. † Number.
Laparoscopic (n ⫽ 66)
Open (n ⫽ 67)
P
3 5 2 3 6 65 1
4 6 5 6 8 58 9
.004 .003 ⬍.0001 ⬍.0001 .017 .017
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felt, paradoxically, to be too “high-risk” for a minimally invasive approach. Several studies have reported that laparoscopic colorectal surgery is safe and feasible and is associated with increased patient satisfaction [13–15]. Our conversion rate of 8% to an open procedure or to a laparoscopicassisted procedure is higher than that in our overall patient population (5%) but compares favorably with what is reported in the literature in this patient subset [9,10,13,16]. The learning curve associated with the performance of an advanced laparoscopic colorectal procedure contributes to patient outcome and has been well documented [17]. The results of the Clinical Outcomes of Surgical Therapy Study Group (COST) trial have proven that laparoscopic colorectal surgery is an acceptable alternative to open surgery for colon cancer when performed by surgeons who have demonstrated appropriate laparoscopic experience and oncologic expertise [18]. Our study was designed to compare outcomes after laparoscopic and open colectomy in a case-matched series of high-risk patients. Our data demonstrated that a laparoscopic approach compares favorably to an open approach in this high-risk subset with regard to perioperative mortality and morbidity. There was no mortality in the LC group. Overall morbidity was significantly lower in the LC group (26%) compared to the OC group (52%). This difference was driven by a substantial reduction in minor complications after minimally invasive surgery. The specific comorbidity, the type of resection performed (proximal vs distal colon) and the length of the procedure were independent variables that did not influence patient outcome with regard to perioperative events, morbidity, or mortality. Differences in morbidity were attributable only to the utilization of a minimally invasive approach. Our results compare favorably with literature reports of a 22% to 79% incidence of overall morbidity, 11% to 29% incidence of minor morbidity, 21% to 28% incidence of major morbidity, and a 0% to 19% mortality rate in this high-risk subset of patients undergoing open colectomy [10,11,19]. The decrease in overall morbidity in the LC group was accompanied by a significant improvement in time to return of bowel function, tolerance of house diet, and hospital discharge. Patients treated laparoscopically were also more likely to be discharged home instead of to an extended care facility or nursing home, as is all to often the case [11,16,20]. This personal experience with laparoscopic colorectal surgery in the high-risk patient suggests that advanced age, obesity, and high ASA classification are not contraindications to a minimally invasive approach. Surgery on this high-risk population is not associated with exceptional mortality or morbidity. This subset of patients seems to fair better when treated laparoscopically as compared to an equally matched group of high-risk patients undergoing open colon resection.
Acknowledgment The authors would like to thank Tim Cooney for his assistance in the statistical analysis and Ron Plocek for participation in formulation of the manuscript.
References [1] Fazio VW, Tekkis PP, Remzi F, et al. Assessment of operative risk in colorectal cancer surgery: the Cleveland Clinic Foundation colorectal cancer model. Dis Colon Rectum 2004;47:2015–24. [2] Longo WE, Virgo KS, Johnson FE, et al. Risk factors for morbidity and mortality after colectomy for colon cancer. Dis Colon Rectum 2000;43:83–91. [3] Ondrulla DP, Nelson RL, Prasad ML, et al. Multifactorial index of preoperative risk factors in colon resections. Dis Colon Rectum 1992; 35:117–22. [4] Leung JM, Dzankic S. Relative importance of preoperative health status versus intraoperative factors in predicting postoperative adverse outcomes in geriatric surgical patients. J Am Geriatr Soc 2001; 49:1080 –5. [5] Liu LI, Leung JM. Predicting adverse postoperative outcomes in patients aged 80 years or older. J Am Geriatr Soc 2000;48:405–12. [6] Spivak H, Maele DV, Friedman IL, et al. Colorectal surgery in octogenarians. J Am Coll Surg 1996;183:46 –50. [7] Zenilman ME, Surgery in the elderly. Curr Probl Surg 1998;35:99 – 179. [8] Arozullah AM, Daley J, Hendersend WG, et al. Multifactorial risk index of predicting postoperative respiratory failure in men after major noncardiac surgery. Ann Surg 2000;232:242–53. [9] Pikarsky AJ, Saida Y, Yamaguchi T. Is obesity a high-risk factor for laparoscopic colorectal surgery? Surg Endosc 2002;16:855– 8. [10] Law WL, Chu KW, Tung PHM. Laparoscopic colorectal resections: a safe option for elderly patients. J Am Coll Surg 2002;195:768 –73. [11] Sklow B, Read T, Birnbaum E, et al. Age and type of procedure influence the choice of patients for laparoscopic colectomy. Surg Endosc 2003;17:923–9. [12] Tuech JJ, Pessauz P, Rouge C, et al. Laparoscopic vs open colectomy for sigmoid diverticulitis: a prospective comparative study in the elderly. Surg Endosc 2000;14:1031–3. [13] Senagore AJ, Delaney CP, Madboulay K, et al. Laparoscopic colectomy in obese and nonobese patients. J Gastrointest Surg 2003;7: 558 – 61. [14] Guller U, Jain N, Hervey S, et al. Laparoscopic vs open colectomy; outcomes comparison based on large nationwide databases. Arch Surg 2003;138:1179 – 86. [15] Velanovich. V. Laparoscopic vs open surgery; a preliminary comparison of quality-of-life outcomes. Surg Endosc 2000;14:16 –21. [16] Stocchi L, Nelson H, Young-Fadok TM, et al. Safety and advantages of laparoscopic vs. open colectomy in the elderly. Dis Colon Rectum 2000;43:326 –32. [17] Reissman P, Cohen S, Weiss EG, et al. Laparoscopic colorectal surgery: ascending the learning curve. World J Surg 1996;20:277– 82. [18] Delgado S, Lacy AM, Garcia Valdecasas, et al. Could age be an indication for laparoscopic colectomy in colorectal cancer? Surg Endosc 2000;14:22– 6. [19] Stewart BT, Stitz RW, Lumley JW. Laparoscopically assisted colorectal surgery in the elderly. Br J Surg 1999;86:938 – 41. [20] Nelson H, Sargent DJ, Weiand HS, et al. A comparison of laparoscopically assisted and open colectomy for colon cancer; the Clinical Outcomes of Surgical Therapy Study Group. N Engl J Med 2004; 350:2050 –9.
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Discussion Erik Wilson, M.D. (Houston, Texas): This study shows a large morbidity advantage for laparoscopic colectomy in high-risk patients. It adds to the published data from randomized trials showing the equivalency or superiority of laparoscopic colectomy. It also supports my bias as a laparoscopic surgeon that a laparoscopic approach is the future of colon surgery. My questions are as follows: While your major complication rate is statistically the same for both the laparoscopic and the open groups, the anastomotic complication rate appeared to be slightly higher. In your laparoscopic arm you had 4 anastomotic complications, and in your open arm you had 1 anastomotic complication. That may not be a statistically significant difference, but with larger numbers of study patients, it certainly could be different. Do you have a reason why that was? Was there a difference in your anastomotic technique comparing laparoscopic versus open? Was there a difference between right and left colons? The other question is, do you think laparoscopic colectomy is now standard care? If you do not, when is it going to become standard of care in your mind? What does it take to become standard of care? Lastly, since currently colon surgery is still performed laparoscopically only in a minority of patients, what is it going to take to train general surgeons and colorectal surgeons to perform this procedure at the volume it probably should be performed at? Daniel P. Geisler, M.D.: There are a number of laparoscopic series that show a slightly elevated incidence of anastomotic complications. In our series in this complex subset of patients, this was not statistically significant. However, there did appear to be a trend for an increased incidence of anastomotic complications in our series. All anastomotic complications in our series occurred in the first quarter of the study and can be attributed to technical issues that have been resolved. I do not believe increased tension is an issue in properly performed cases as I routinely take down the splenic flexure to allow for a tension-free anastomosis. In the past 100 or so cases, we have not had any anastomotic complications. In regards to standard of care, I think that may come quicker than many think. If you pooled all colorectal sur-
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geons, you would find about 5% of colon resections were being done laparoscopically. The initial hope was that in the next 10 years that number would triple or quadruple, which means only 15% to 20% of all resections be performed laparoscopically. However, I think that it may take off a lot quicker than that. We have seen significant growth in our community as the demand for a minimally invasive approach by both patients and referring doctors has been quite strong. Over the past 2 years, the percent of colorectal resections done laparoscopically in our community has grown from less than 1% to 38% of all cases. This included all procedures performed by general and colorectal surgeons, so it is increasing rather quickly. Proper training obviously can expedite the learning curve and must remain at the forefront of the laparoscopic movement. I do go out of my way to train the resident to be sure that they’re comfortable performing this operation, realize that the same strict surgical principles pertain to laparoscopic surgery as they do to open procedures, and to convert to an open operation if there is any question. The residents that we are now training all appear comfortable going out into practice, and I think that this will become the norm more and more across the United States. Erik Wilson, M.D.: It looked to me like 5% of your cases were lap-assisted, which would represent 3 cases out of the series. Does that mean that your right colons (which appeared to be more than 3 cases) were actually done with intracorporeal anastomoses, or did you do extracorporeal anastomoses on those? Daniel P. Geisler, M.D.: On the right colons, I do a periumbilical incision that typically measures between 4 and a half, and 5 and a half centimeters. That’s the specimen extraction site with the anastomosis being performed extracorporeally with a GIA and TA stapler. I qualify a laparoscopic-assisted procedure as one in which the transection of the bowel as well as the anastomosis is performed extracorporeal after the vessels have been taken intracorporeally. Erik Wilson, M.D.: So you don’t count the right colons as lap-assisted, you count those completely laparoscopic? Daniel P. Geisler, M.D.: Yes. Even though it’s not truly an intracorporeal anastomosis, an incision of 4 and a half centimeters, I qualify as a laparoscopic procedure.