Improved Outcomes in Colon and Rectal Surgery part 29 pptx

 improved outcomes in colon and rectal surgery public and private initiative to develop standardized surveys of patients’ experiences with ambulatory and facility-level care.(86) CAHPS surveys provide information about patients’ care expe- riences rather than traditional clinical performance indicators, such as cured of disease or morbidity and mortality. The surgeons’ ability to measure and understand quality-of- life and other patient centered outcome would be of great value to the colorectal cancer patient undergoing surgery. In practical terms, patient expectations would be clearer. Few tested and useful patient centered metrics have been evaluated and even fewer are in use today.(87) Despite the lack of real progress in this area, insur- ers, patients, and others are very interested in determining what patients think of the treatments we provide them. At this time, sur- geons need to work closely with others to facilitate more compre- hensive and nontraditional outcomes following surgical care. COnClUsiOn In summary, this chapter on improving outcomes for abdomi- nal surgery in colorectal cancer provides an overview of poten- tial complications, methods to reduce complications, methods to improve outcomes, surgical outcomes presently measured, and the future of patient-centered outcomes in colorectal cancer sur- gery. We have particularly emphasized the impact of the quality movement and the role of outcomes on quality measurement and assurance. The information presented in this chapter is critical as quality metrics and measurement are likely to become more and more important to the individual practitioner. Given that sur- gery for colorectal cancer has become increasingly more technical due to the refinement of open as well as laparoscopic techniques, outcomes measurement will become more and more important as we prove to our patients, payers, Congress, and ourselves that our outcomes are optimal. Although payers and other govern- ment groups have become the drivers of quality improvement, it is our duty to measure our own outcomes, assess the quality of care that we provide, and compare our own results with our col- leagues. Internal efforts to improve quality are the most likely to bring about real meaningful changes in outcomes for colorectal cancer. ReFeRenCes 1. Jagoditsch M, Lisborg PH, Jatzko GR et al. Long term prog- nosis for colon cancer related to consistent radical surgery: multivariate analysis of clinical, surgical, and pathologic variables. World J Surg 2000; 24: 1264–70. 2. Mcdermott FT, Hughes ESR, Pihl E et al. Comparative results of surgical management of single carcinomas of the colon and rectum: a series of 1,939 patients managed by one surgeon. Br J Surg 1981; 68: 850. 3. Chapuis PH, Dent OF, Fisher R et al. A multivariate analy- sis of clinical and pathological variables in prognosis after resection of large bowel cancer. Br J Surg 1985; 72: 698–702. 4. Tominaga T, Sakabe T, Koyama Y et al. Prognostic factors for patients with colon or rectal carcinoma treated with resection only. Five-year follow-up report. Cancer 1996; 78: 403–8. 5. Swanson RS, Compton CC, Stewart AK, Bland KI. The prog- nosis of T3N0 colon cancer is dependent on the number of lymph nodes examined. Ann Surg Oncol 2003; 10: 65–71. 6. Compton CC, Fielding LP, Burgart LJ et al. Prognostic fac- tors in colorectal cancer. College of American Pathologists Consensus Statement 1999. Arch Pathol Lab Med 2000; 124: 979–94. 7. Wolmark N, Fisher B, Wieand HS et al. The prognostic sig- nificance of preoperative carcinoembryonic antigen levels in colorectal cancer. Results from NSABP (National Surgical Adjuvant Breast and Bowel Project) clinical trials. Ann Surg 1984; 199: 375–82. 8. Langevin JM; Nivatvongs S. The true incidence of synchro- nous cancer of the large bowel. A prospective study. Am J Surg 1984; 147: 330–3. 9. Nagtegaal ID, Quirke P. What is the role for the circumferen- tial margin in the modern treatment of rectal cancer? J Clin Oncol 2008; 26: 303–12. 10. Quirke P, Dixon MF, Dundey P et al. Local recurrence of rectal adenocarcinoma due to inadequate surgical resection: histopathologic study of lateral tumor spread and surgical excision. Lancet 1986; 2: 996–8. 11. Vernava AM, Moran M, Rothenberger DA, Wong WD. A prospective evaluation of distal margins in carcinoma of the rectum. Surg Gynecol Obstet 1992; 175: 333–6. 12. Rouffet F, Hay J-M, Vacher B et al. Curative resection for left colonic carcinoma: hemicolectomy vs. segmental colec- tomy. A prospective, controlled, multicenter trial. Dis Colon Rectum 1994; 37: 651–9. 13. Nelson H, Petrelli N, Carlin A et al. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst 2001; 93: 583–96. 14. Otchy D, Hyman NH, Simmang C et al. Practice parameters for colon cancer. Dis Colon Rectum 2004; 47: 1269–84. 15. Hermanek P. [Oncologic surgery/pathologic-anatomic view- point]. Langenbecks Arch Chir Suppl Kongressbd 1991; 277–81. 16. ASCO/NCCN Quality Measures: Breast and Colorectal Cancer http://preview.asco.org/portal/site/ASCO/menuitem .5d1b4bae73a9104ce277e89a320041a0/?vgnextoid=1b08fcd 4eb46c010VgnVCM100000ed730ad1RCRD accessed May 6, 2007. 17. Compton CC. Updated protocol for the examination of specimens from patients with carcinomas of the colon and rectum, excluding carcinoid tumors, lymphomas, sarcomas, and tumors of the vermiform appendix: a basis for checklists. 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The effect of stapler diameter and proximal colostomy on narrowing at experimental circular stapled large bowel anastomosis. Aust N Z Surg 1986; 56: 797–801. 41. Matos DDM, Atallah A, Castro A, Silva Lustosa SA. Stapled versus handsewn methods for colorectal anastomosis sur- gery. Cochrane Database Syst Rev 2001; 3: CD003144. 42. Suchan KL, Muldner A, Manegold BC. Endoscopic treatment of postoperative colorectal anastomotic strictures. Surgical endoscopy 2003; 17: 1110–3. 43. Forshaw MJ, Maphosa G, Sankararajah D, Parker MC, Stewart M. Endoscopic alternatives in managing anastomotic stric- tures of the colon and rectum. Tech Coloproctol 2006; 10: 21–7. 44. Cirocco WC, Golub RW. Endoscopic treatment of postop- erative hemorrhage from a stapled colorectal anastomosis. American Surgeon 1995; 61: 460–3. 45. Malik AH, East JE, Buchanan, Kennedy RH. Endoscopic haemostasis of staple-line hemorrhage following colorectal resection. Colorectal Dis 2008; 10(6): 616–8. 46. Choy PYG, Bissett Ip, Docherty JG, Parry BR, Merrie AEH. Stapled versus handsewn methods for ileocolic anastomoses. Cochrane Database of Syst Rev 2007; 3: CD004320. 47. Murray JJ, Schoetz DJ Jr. Stapling techniques in rectal sur- gery, In: Fazio VW(ed.) Current therapy in colon and rectal surgery. Philadelphia: BC Decker, 1990: 384–90. 48. Chardavoyne R, Stein TA, Ratner LE et al. Is colonoscopy safe in the early postcolectomy period? Am Surgeon 1991; 57: 734–36. 49. Chassin JL, Rifkind KM, Turner JW. Errors and pitfalls in stapling gastrointestinal tract anastomoses. Surg Clin N Am 1984; 64: 441–59. 50. Charlmers AG. Robinson PJ, Chapman AH. Embolisation in small bowel hemorrhage. Clin Radiology 1986; 37: 379–81. 51. Dubois JJ, Ostrow LB, Smith GB, Welling DR. Transcatheter embolization of small bowel anastomosis: A case report and review of the literature. Military Med 1989; 154: 505–7. 52. Atabek U, Pello MJ, Spence RK et al. Arterial vasopressin for control of bleeding from a stapled intestinal anastomosis. Report of two cases. Dis Colon Rectum 1992; 35: 1180–2. 53. Wang QY, Shi WJ, Zhou WQ, He ZR. New concepts in severe presacral hemorrhage during proctectomy. Arch Surg 1985; 120: 1013–20. 54. Khan FA, Fang DT, Nivatvongs S. Management of presacral bleeding during rectal resection. Surg Obst Gyn 1987; 165: 275–6. 55. Hill AD, Menzies-Dow N, Darzi A. Methods of controlling presacral bleeding. JACS 1994; 178: 183–4. 56. Xu J, Lin J. Control of presacral hemorrhage with electrocau- tery through a muscle fragment pressed on the bleeding vein. JACS 1994; 179: 351–2 57. Civelek A, Yegen C, Aktan AO. The use of bonewax to control massive presacral bleeding. Surg Today 2002; 32: 944–5. 58. Konstadoulakis MM, Kymionis GD, Leandros E et al. Long term effect of splenectomy on patients operated on for can- cer of the left colon: a retrospective study. Eur J Surg 1999; 165: 583–87.  improved outcomes in colon and rectal surgery 59. Lord MD, Gourevitch A. The peritoneal anatomy of the spleen with special reference to the operation of partial gast- rectomy. Br J Surg 1965; 52: 202–4. 60. Cioffiro W, Schein CJ, Gliedman ML. Splenic injury during abdominal surgery. Arch Surg 1976; 111: 167–71. 61. Olsen W, Beaudoin D. Surgical Injury to the Spleen. Surg, Gynecol, Obstet 1970; 131: 57–62. 62. Cassar K, Munro A. Iatrogenic splenic injury. J R Coll Surg Edin 2002; 6: 731–41. 63. Fabri PJ, Metz EN, Nick WV, Zollinger RM. A quarter cen- tury with splenectomy. Changing concepts. Arch Surg 1974; 108: 569–75. 64. Rodkey GV, Welch CE. Changing patterns in the surgical treat- ment of diverticular disease. Ann Surg 1984; 200: 466–78. 65. McGory ML, Zingmond DS, Sekeris E, Ko CY. The signifi- cance of inadvertent splenectomy during colorectal cancer resection. Arch Surg 2007; 142: 668–74. 66. Malek MM, Greenstein AJ, Chin EH et al. Comparison of Iatrogenic Splenectomy During Open and Laparoscopic Colon Resection. Sur Laparosc Endosc Percutan Tech 2007; 17: 385–7. 67. Falsetto A, Della Corte M, De Pascale V, Surfaro G, Cennamo A. Iatrogenic splenic injuries. Ann Ital Chir 2005; 76: 175–81. 68. Scheele J, Gentsch HH, Matteson E. Splenic repair by fibrin tis- sue adhesive and collagen and fleece. Surgery 1984; 95: 6–13. 69. Working Party of the British Committee for Standards Clincal Hematology Task Force. Guidelines for the preven- tion and treatment of infection in patients with an absent of dysfunctioned spleen. Br Med J 1996; 312: 430–3. 70. Higgins CC. Ureteral injuries during surgery. A review of 87 cases. JAMA 1967; 199: 82–8. 71. Al-Awadi K, Kehinde EO, Al-Hunayan A, Al-Khayat A. Iatrogenic ureteric injuries: incidence, aetiological factors and the effect of early management on subsequent outcome. Int Urol Nephrol 2005; 37: 235–41. 72. Hamawy K, Smith JJ III, Libertino JA. Injuries of the distal ureter. Seminar Colon Rectal Surg 2000; 11: 163–79. 73. Pocard M, Zindindohoue F, Haab F et al. A prospective study of sexual and urinary function before and after total mesorectal excision with autonomic nerve preservation for rectal cancer. Surgery 2002; 131: 368–72. 74. Heald RJ, Ryall RD. Recurrence and survival after total mesorectal excision for rectal cancer. Lancet 1986; 1: 1479–82. 75. Nesbakken A, Nygaard K, Bull-Njaa T, Carlsen E, Eri LM. Bladder and sexual dysfunction after mesorectal excision for rectal cancer. Br J Surg 2000; 87: 206–10. 76. McDonald PJ, Heald RJ. A survey of postoperative function after rectal anastomosis with circular stapling devices. Br J Surg 1983; 70: 727–9. 77. McAnena OJ, Heald RJ, Lockhart-Mummery HE. Operative and functional results of total mesorectal excision with ultra- low anterior resection in the management of carcinoma of the lower one-third of the rectum. Surg Gynecol Obstet 1990; 170: 517–21. 78. Batignani G, Monaci I, Ficari F et al. What affects continence after anterior resection of the rectum? Dis Colon Rectum 1991; 34: 329–35. 79. Lewis WG, Holdsworth PJ, Stephenson BM et al. Role of the rectum in the physiological and clinical results of coloanal and colorectal anastomosis after anterior resection for rectal carcinoma. Br J Surg 1992; 79: 1082–6. 80. Karanjia ND, Schache DJ, Heald RJ. Function of the distal rectum after low anterior resection for carcinoma. Br J Surg 1992; 79: 114–6. 81. Lewis WG, Martin IG, Williamson ME et al. Why do some patients experience poor functional results after anterior resection of the rectum for carcinoma? Dis Colon Rectum 1995; 38: 259–63. 82. Miller AS, Lewis WG, Williamson ME et al. Factors that influence functional outcome after coloanal anastomosis for carcinoma of the rectum. Br J Surg 1995; 82: 1327–30. 83. Brown SR, Seow-Choen F. Preservation of rectal function after low anterior resection with formation of a neorectum. Semin Surg Oncol 2000; 19: 376–85. 84. Fazio VW, Zutshi M, Remzi FH et al. A randomized multi- center trial to compare long-term functional outcome, qual- ity of life, and complications of surgical procedures for low rectal cancers. Ann Surg 2007; 246: 481–90. 85. Machado M, Nygren J, Goldman S, Ljungqvist O. Similar outcome after colonic pouch and side-to-end anastomosis in low anterior resection for rectal cancer: a prospective ran- domized trial. Ann Surg 2003; 238: 214–20. 86. Consumer Assessment of Healthcare Providers and Systems. Agency for Healthcare Research and Quality. URL: https:// www.cahps.ahrq.gov/default.asp. 87. Morris AM. Patient-centered outcomes after therapy for colorectal cancer. Surg Oncol Clin N Am 2006; 15: 195–211.  6 Transanal approaches to rectal cancer Sachin S Kukreja and Theodore J Saclarides CHALLENGING CASE A 67-year-old male underwent a screening colonoscopy and is referred because a 3 cm adenocarcinoma was found approxi- mately 12 cm from the anal verge. Preoperative workup with a transrectal ultrasound and CT scan showed the lesion appeared to be a uT1N0 cancer without metastatic disease. He has multi- ple medical problems including a myocardial infarction 3 months prior and is not felt to be a good candidate for radical surgery. CASE MANAGEMENT The patient is offered Transanal Endoscopic Microsurgery (TEM); a complete full-thickness excision is successfully performed. Post- operatively, he has urinary retention. A bladder scan reveals 700 L of urine within the bladder and catheterization is performed. The retention resolves overnight and the patient is discharged the next morning. Pathologic evaluation of the specimen revealed a pT1N0 rectal cancer. INTRODUCTION There are approximately 42,000 newly diagnosed rectal cancers in the United States each year and approximately 9,500 people die from their disease. Although adjuvant therapies continue to improve outcomes, surgical management remains the cornerstone of therapy as few patients can be cured without a surgical resection. Surgical approaches are varied and are chosen based on the degree of rectal wall invasion, tumor histology, the presence or absence of lymph node metastases, involvement of the anal sphincter and nearby pelvic structures, and disease comorbidities. Either a local excision (with or without adjuvant therapy) or radical, transab- dominal surgery (and possible chemoradiation) can be chosen. The surgical management for rectal cancer has been evolving signifi- cantly over the last few decades and across geographic boundaries. RECTAL CANCER AND SURGICAL OPTIONS Traditional and more commonly applied treatment with total mesorectal excision (TME) through either a low anterior (LAR) or abdominoperineal resection (APR) is the standard against which other procedures are compared. Such interventions are not without significant morbidity, including anastomotic leak, wound infection or dehiscence, colostomy malfunction, or pelvic dissec- tion complications (including defecatory, urinary and sexual dys- function, and fecal incontinence). Although such techniques are well-accepted treatment modalities, the search for less invasive and less morbid techniques that provide sphincter preservation and acceptable cure rates has led to the evolution of a wide vari- ety of alternative surgical procedures. Although less-invasive pro- cedures including transanal fulguration, endocavitary radiation, and transsphincteric or transsacral approaches have been utilized, the transanal approaches have proven to be the most popular and safest overall with less morbidity and mortality.(1) Determining whether a patient may be a candidate for sphinc- ter preservation (either through trans-anal or trans-abdominal means) usually begins during the patient’s initial assessment. More often than not, the patient comes to the surgeon after having already undergone lower endoscopy. Rectal bleeding may have prompted an evaluation or the patient may have been asympto- matic. Nonetheless, key questions related to the patient’s bowel habits are critical in the assessment. Symptoms of tenesmus often signal the presence of a large tumor which usually requires radi- cal transabdominal surgery. Anal pain, with or without defeca- tion may imply involvement of the anal sphincters or pelvic floor, precluding a sphincter-preserving operation. Patients with fecal incontinence should be identified in the preoperative workup since proctectomy and sphincter preservation may worsen conti- nence, condemning them to significant fecal soilage, even if such a procedure is technically possible. Both digital rectal exam (DRE) and rigid sigmoidoscopy are required in the evaluation. Localizing the lesion to the lower, mid- dle, or upper third of the rectum helps determine what options the patient may have. Involvement of the anal sphincter, the tumor’s spatial relationship to the anorectal ring, and fixation to the pelvic side walls are important physical findings that help guide the deci- sion making process. Additionally, the patient’s overall medical status must be taken into consideration as some may not be able to tolerate a large abdominal operation due to a myriad of comor- bidities. Finally, before planning surgery, a complete colonoscopy is essential to rule out synchronous lesions elsewhere in the colon. Accessible well-differentiated cancers that are <4 cm in size, lack lymphovascular invasion, occupy <40% of the bowel wall circumfer- ence, and do not invade the muscularis propria have historically been considered the most amenable to a transanal approach. Although these criteria are not necessarily strict guidelines, tumors larger than this are associated with a significantly higher incidence of lymph node metastasis. Many authors will not offer a transanal approach for lesions larger than 3 cm in diameter due to the risk of incomplete excision. Upon DRE, those masses that are immobile and fixed are likely to be transmural and hence, require a traditional TME surgery following neoadjuvant therapy. It is well established that even in the most experienced of hands, manual exam alone can differentiate T1/ T2 tumors from T3/T4 tumors only 80% of this time. Lymph node metastases can be detected digitally in only 50% of instances.(2) Rigid proctosigmoidoscopy allows the clinician to evaluate and more accurately localize the tumors beyond what is within reach of the DRE within the middle and upper rectum. Lesions that may have been labeled as being 15 cm from the anal verge with flexible endoscopy may be closer to the anus when evaluated with a rigid scope. Various imaging modalities exist and should be uti- lized to assess depth of invasion and the presence of lymph node involvement; these include CT scan, MRI, and transrectal ultra- sound (TRUS). With its ease of use, widespread availability, and high  improved outcomes in colon and rectal surgery overall accuracy, many clinicians rely on TRUS in their standard preoperative work-up for rectal cancer and consider it to be the best method of preoperative staging. Many series cite an accuracy rate of 90% for staging rectal wall penetration and an 80% accuracy rate for assessing the status of the perirectal lymph nodes. Factors such as peritumoral fibrosis, inflammation, increasing tumor height, and operator experience have all been shown to decrease the sensitivity of TRUS.(3) Some authors recommend the routine use of MRI with endorectal coils to maximize sensitivity.(4) Although traditionally indicated for only early (T1) lesions, trans-anal excision (TA) and TEM can be offered to patients with more advanced disease in spe- cific clinical circumstances especially when combined with radiation and chemotherapy. Conventional TA is more commonly utilized in the United States than TEM; however, neither approach is capable of addressing nodal disease to its full extent. As a result, appropriate patient selection is critical when using either procedure with cura- tive intent. Compared to TA, TEM is more likely to achieve negative margins and cause less specimen fragmentation. TRANSANAL EXCISION A significant number of low rectal cancers (less than 5–10 cm from the anal verge) can be approached by transanal excision, particu- larly those that are early stage. The justification for less invasive techniques is largely established by the low rate of nodal metasta- ses in T1 disease. In the absence of significant nodal involvement identified by CT, MRI, or TRUS, one can estimate the incidence of positive lymph nodes to be 3%—if the lesion is favorable (well to moderately differentiated, confined to the mucosa and submucosa, have no vascular invasion, and small size). By contrast, poor histo- logical grade confers a 12% risk of nodal involvement.(5) Clearly, the issues are the ability to identify nodal involvement before surgi- cal intervention and to remove the lesion with negative margins. Local excision (TA) is considered acceptable for T1 adenocar- cinomas that carry favorable prognostic features. Such character- istics include small size (<4 cm), lack of fixation, histology that is either moderately or well-differentiated and absence of vascular, perineural, or lymphatic invasion. Reports describe cure rates as high as 90% with a recurrence rate of <10% for patients with the above characteristics. Unfortunately, there is significant variation in the data, as a recent review of 41 retrospective studies shows a 5-year local recurrence rate of 12% with a range of 0–19%.(6) As a general rule, local excision may be considered for less invasive tumors with good histological characteristics. Local excision can be considered for T1 and T2 (controversial) lesions depending on the clinical circumstance, but is considered contraindicated for T3 (par- ticularly without adjuvant modalities) if one seeks oncologic cure. Comparable oncologic outcomes could be expected in T1 low risk rectal cancers removed with local excision without adjuvant ther- apy when compared with classic total mesorectal excision (TME). However, the outcomes are significantly worse for T2 lesions when adjuvant therapies were not applied. Recurrence rates in early T1 and T2 disease are clearly affected by unfavorable histological character- istics (e.g., Grade III, lymphovascular invasion). Because of this, local excision alone is considered inadequate for T2, T3 tumors; some authors, however, offer these patients neoadjuvant therapies. Although there is clearly a role for TA excision in T1 disease with favorable characteristics, many surgeons are looking at the feasibility of treating more advanced cancers with less invasive modalities than traditional TME. Studies that have evaluated outcomes with T2 and T3 tumors are difficult to interpret due to overall small population size and their retrospective nature; however, several clinical reports demonstrated promise for treat- ing more advanced disease, some showed improved outcomes with adjuvant therapies before or after local excision.(7) A single multicenter trial showed that local excision could control rectal adenocarcinoma and reduce sphincter dysfunction with an over- all 6-year survival of 85% and disease-free survival rate of 78% in select T1 and T2 cancers (<4 cm, <40% circumference, negative histological margins, and node-negative). It should be noted that the oncologic outcomes for T1 lesions and T2 lesions treated with adjuvant chemoradiation were roughly equivalent and differences between histological grade was not evaluated.(8) Locally advanced T3 rectal cancers represent an area of evolving research. Although most centers offer such patients neoadjuvant therapies followed by TME, some surgeons are attempting TA excision on these tumors with satisfactory results. In a 2002 study from the University of Florida, Dr. Schell performed TA excision on patients whose tumors had been significantly downstaged from T3 with neoadjuvant chemoradiation (15% of patients of an initial 74). There was no local recurrence or nodal metastasis after a mean follow-up of 55.2 ± 8.9 months (one patient devel- oped distant metastasis). These patients had lesions 1–7 cm from the anal verge. Although the overall study size was limited and should not be considered the standard of care, it offers promise for those patients with advanced disease who may not be candidates for or refuse TME.(9) Similar results were demonstrated at the University of South Florida in 2001. Twenty-six patients with T2 or T3 disease (5 uT2N0, 13T3N0, 7T3N1 and 1 un-staged patient) underwent neoadjuvant therapy and subsequent local excision. Following excision, no specimens had vascular, neural, or lym- phatic invasion and six contained lymph nodes in the perirectal fat without evidence of metastatic disease. Partial pathologic response was demonstrated in nine and complete response in 17 patients. Of the partial responders, all were offered but only two underwent subsequent APR. With a mean follow-up of 24 months, none of the complete responders had demonstrated recurrence.(10) Transanal excision may remove perirectal lymph nodes directly adjacent to the lesion while other nodes in the mesorectum may still harbor metastatic disease. For this reason, some authors favor adjuvant or neoadjuvant therapy (radiation with or with- out chemotherapy) for more advanced lesions. The majority of studies reporting recurrence rates are variable in their follow-up and ultimate outcomes making interpretation difficult, but the data does suggest a benefit for adjuvant therapies in this setting. Risk factors for recurrence are related to the depth of the primary tumor, surgical margins, histologic grade, and the status of the perirectal nodes. Overall recurrence rates are decreased when local excision is combined with radiation and chemotherapy, ranging from 0–15% for T1 and T2 lesions, and 0–20% for T3 lesions. (11–16) A review of the literature with regards to local excision and recurrence rates with and without adjuvant therapies was performed by Sengupta in 2001.(6) A summary of outcomes in these patients is summarized and demonstrates the variability in recurrence rates (Table 26.1).  transanal approaches to rectal cancer TECHNIQUES OF TRANSANAL EXCISION Before surgery, rigid proctoscopy is done to determine the exact location of the lesion and whether or not it is accessible with conventional instrumentation. The rest of the colon is checked for synchronous neoplasms with either colonoscopy or a contrast enema. Overall fitness for general anesthesia is determined. In preparation for the operation, a bowel cleansing is performed, this will eliminate formed stool from the rectum and enhance visibil- ity. The patient is positioned on the operating room table so that access to the lesion is provided, this usually necessitates the prone position for anterior lesions, the lithotomy position for posterior lesions, and the decubitus position for laterally based lesions. Various self-retaining retractors are available and are placed in the anus and deployed. Once the lower edge of the lesion is visualized, a clamp is placed on normal mucosa under the lesion and down- ward traction is applied to the clamp. Stay sutures may facilitate this process. This downward traction is an ongoing process dur- ing excision so that the entire lesion is delivered into the operative field. A rim of normal appearing mucosa is marked with cautery points around the lesion and then a full thickness excision is per- formed. It is important to obtain hemostasis as one proceeds since a bloodless field is vital for maintaining visibility. Once the lesion is excised, the wound is closed transversely so as to avoid nar- rowing the rectal lumen. Transanal excision using conventional instrumentation is limited to lesions located in the lower and pos- sibly the mid rectum and for lesions which are not larger than 3 to 4 cm in diameter. More proximally located or larger lesions may be beyond the capability of these retractors, however, this is highly variable depending on the surgeon’s expertise, the body habitus of the patient, and the laxity of the rectal wall. Overall the complication rate from transanal excision is con- sidered low and is usually limited to urinary retention, urinary tract infection, bleeding, fecal impaction, and infections in the perirectal and ischiorectal space. Most series cite a mortality of virtually zero. TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) The introduction of Transanal Endoscopic Microsurgery (TEM) by G. Buess over two decades ago opened the door to transanal resection of lesions (both benign and malignant) beyond the reach of conventional TA instruments with increasingly favorable results through a method less invasive than radical open surgery. Additionally, appropriately sized tumors with certain specified histological characteristics could be removed with outcomes com- parable to traditional surgery. With the potentially high recur- rence rate of pT1 disease with TA excision and the morbidity of traditional TME, many surgeons have been investigating TEM. When compared with TA excision, the technique of TEM allows for superior visualization, access to lesions further from the anal verge within the mid and upper rectum, en-bloc resection rather than fragmentation, and possible excision of the mesorectal fat and the nodes contained within (Figure 26.1). Local recurrence rates may be lower with TEM (compared with TA) excision due to a reduced risk of implantation of viable tumor cells in the wound, less tissue fragmentation of the tumor, and a higher likelihood of obtaining negative margins.(1) The safety and outcomes for TEM in T1 lesions with favorable characteristics has been well-established. For this reason, TEM alone is only indicated for T1 tumors if one seeks oncologic cure. Multiple clinical trials have shown favorable oncologic outcomes Table 26.1 Local Recurrence Rates by T-stage and Adjuvant Therapy (Sengupta, 2001, Ref. 6). Local Recurrence Rates (%) Study Follow-up Local Excision Alone Local Excision and Adjuvant Therapy T1 T2 T3 T1 T2 T3 Mellgren et al. 2000 4.4 years 18 a 47 a Russell et al. 2000 6.1 years 7 (1/14) 0 (0/13) 16 (4/25) 23 (3/13) Chakravarti et al. 1999 51 month 11 a 67 a 0 a 15 a Graham et al. 1999 56 month 0 (0/4) 0 (0/2) 0 (0/9) 0 (0/5) Steele et al. 1999 48 month 5 (3/59) 13.7 (7/51) Varma et al. 1999 6 years 4.7 (1/21) 45.5 (5/11) 25 (1/4) 0 (0/3) 0 (0/9) 0 (0/6) Wagman et al. 1999 41 month 0 (0/8) 24 (6/25) 25 (2/8) Le Voyer et al. 1999 46 month 6.7 (1/15) 12.5 (2/16) 25 (1/4) Benoist et al. 1998 57 month 10 (2/19) 25 (2/8) 33 (1/3) Kim and Madoff 1998 NS 9 (4/44) 24 (6/25) 50 (1/2) Taylor et al. 1998 52 month 24 (6/25) 50 (4/8) 100 (1/1) 50 (1/2) 11 (1/9) 50 (1/2) Bleday 1997 40.5 month 9 (2/22) 0 (0/21) 40 (2/5) Valentini et al. 1996 54 month 11 (1/9) 17 (2/12) Baron et al. 1995 55.3 month 19 (8/42) 20 (7/34) 27 (3/11) Frazee et al. 1995 30 month 10 2/21 0 (0/9) 0 (0/2) Willett et al. 1994 48 month 17 a 20 a Ota et al. 1992 36 month 0 (0/16) 6.7 (1/15) 20 (3/15) Huber and Koella 1992 NS 22 (2/9) 23 (3/13) 33 (2/6) Cuthbertson and Simpson 1986 51 month 12.5 44 (4/9) Killingback 1985 >18 month 17.8 (5/28) 33 (2/6) Steams et al. 1984 ≥5 years 6.7 (1/15) 14 (2/14) 50 (1/2) Hager et al. 1983 33–40.5 month 8.3 (3/36) 16.7 (3/18) Note: NS = not stated. a. Five-year actuarial local recurrence rates.  improved outcomes in colon and rectal surgery and low morbidity with virtually zero mortality. Winde was the first to demonstrate in a randomized prospective trial that there was no statistically significant difference in outcome between TEM (n = 24) and open radical surgery (n = 26) for pT1 tumors with a 5-year survival of 96% for both techniques. Overall, the local recurrence rate was 4.1% for TEM (0% with radical surgery). Patients who underwent TEM had decreased operative times, less blood loss, a shorter hospital stay, lower analgesic needs, and less morbidity.(17) Our personal experience from 1991–2003 (n = 53) showed low recurrence rates and acceptable oncologic results in patients with pT1 disease. In these patients, the average distance from the anal verge was 7 cm (25% of which were further than 10 cm from the anal verge) and the average tumor size was 2.4 cm with a local recurrence rate of 7.5%.(18) Using TEM to cure rectal cancer has been largely limited to “low-risk” T1 lesions while its role in T2 and T3 lesions is evolving. TEM without adjuvant therapy is inadequate for T2 and greater lesions and can be expected to have recurrence rates of 20–25%. Tumors staged to pT2 have a high risk of lymph node metastasis (16–40%).(5) Because many patients with rectal cancer are older, may be either unfit to undergo radical resection, or refuse TME due to its morbidities and the potential for an ostomy, many seek to broaden the applications of TEM. Multiple trials have taken place to evaluate the feasibility of achieving adequate oncologic results with the overall improved morbidity profile of TEM. In a study aimed to more clearly identify T2 disease as potentially amenable to TEM, Lezoche randomized 70 patients equally to either TEM or LAR following neoadjuvant therapy. These patients all had tumors <6 cm from the anal verge and were <3 cm in overall size. After a minimum 5-year follow-up (median 84 months), the local recurrence rate was 5.7% with TEM and 2.8% with LAR. Distant metastasis was observed in 2.8% with both population groups having equivalent survival of 94%.(19) Similar results were noted when TEM and radical surgery groups were compared when T1 (n = 52 and 17, respectively) and T2 (n = 22 and 83, respectively) lesions followed for 5 years after TEM excision without adjuvant therapies. Their 5-year survival was equiv- alent but the TEM group demonstrated a significantly increased local recurrence rate for T2 lesions at 19.5% vs. 9.4%.(20) Other studies followed the course of disease in those patients that were either upstaged after what was thought to be T1 disease before excision but did not receive further surgical therapy, or those who were unfit or unwilling to undergo a more radical operation for their advanced disease at time of initial presentation. Borschitz retrospectively evaluated patients who had undergone TEM exci- sion of “low-risk” T1 lesions, but were found to be pT2 (n = 44) and did not undergo further surgery or treatment (n=14). It was determined that local excision for T2 lesions was insufficient with- out adjuvant therapies or radical reoperative resection. This was true despite an R0 resection, “low-risk” lesions had a 29% local recurrence rate within less than 2 years’ follow-up. If the patients were “high-risk” or had positive or unclear histological margins, the recurrence rate nearly doubled. “High-risk” lesions had poor tumor grade, lymphatic invasion, or blood vessel involvement. With imme- diate (within 4 weeks) reoperation, these patients had outcomes similar to conventional surgery barring the presence of lymph node metastasis. In those patients with “high-risk” characteristics, lymph node metastases were more common and occurred despite reoperation with significant local and systemic recurrence rates. These patients should receive adjuvant chemoradiation following their radical resections per standard protocols.(21) Although there are more studies analyzing outcomes of TEM with both adjuvant and neoadjuvant therapy, studies of adequate size and power are still lacking and the indications for local curative surgery for lesions more advanced than T1 remain gray. In conclusion, there are few prospective studies evaluating the benefits of adjuvant therapies and retrospective studies can be dif- ficult to interpret. Overall, like transanal excision, recurrence rates for lesions treated with TEM combined with adjuvant therapy are lower when compared to TEM alone for T2 lesions. Preliminary results and reviews of smaller trials comparing TEM excision of T2 lesions with postoperative chemoradiation seem to be on par with the results of APR with adjuvant therapy from an oncologic per- spective. As a result, the recommendation from some is to provide adjuvant therapies for all lesions that are T2 or greater; whereas TEM or TA alone are considered acceptable for T1 “low-risk” lesions given the low likelihood of lymph node involvement. TECHNIQUES OF TRANSANAL ENDOSCOPIC MICROSURGERY TEM resolves many of the limitations posed by conven- tional transanal excision techniques, namely limited access to lesions located beyond the distal rectum and poor visibility. Consequently, the applicability of minimally invasive surgery for rectal cancer is broadened. TEM employs an airtight, self- contained system that constantly distends the rectum with carbon dioxide insufflation, this along with the magnification provided by the scope greatly improves visibility and allows for a more precise excision and wound closure. As a result, one is more likely to obtain tumor-free margins and avoid tumor frag- mentation during the operation. The combined endosurgical unit regulates four functions simultaneously. In addition to gas insufflation, it allows for suction of smoke and blood, irrigation of the scope lens, and monitoring of intrarectal pressure. The stereoscopic binocular eyepiece provides four times magnifica- tion of the field, alternatively, vision may be transmitted to a video monitor. The long shafted instruments necessary for the dissection are inserted through air tight working ports on the Figure 26.1 Schematic of TEM Specimen.  transanal approaches to rectal cancer facepiece of the scope which is 20 cm in length. Depending on the curvature of the sacrum, this scope may easily reach lesions located in upper rectum or even at the rectosigmoid junction. Patients are prepared for surgery in a fashion similar to con- ventional transanal excision. A bowel cleansing is paramount. The operation is performed under general anesthesia. Patients are positioned on the operating room table so that the lesion is located downward relative to the end of the scope. Again, for posterior lesions, patients are placed in the lithotomy position, while the prone position is chosen for anterior lesions. Once the lesion is visualized, cautery points are placed 1 cm around the lesion and a full thickness excision is performed. The specimen is then fixed to a cork board or Telfa paper in order to orient the pathologist to the deep and lateral margins. The wound is closed transversely with a monofilament suture. Most patients can be released the same day. COMPLICATIONS OF TRANSANAL AND TEM The complication rates of TEM are significantly lower than traditional radical surgery. In a review of 12 studies performed by Casadesus in 2006, the morbidity of 893 patients was evaluated. (22) Complications were noted in 15.9% of the patients overall, more than half of which were related to urinary retention or tran- sient incontinence. These complications are typically seen early in the postoperative period and very few patients required interven- tion other than catheterization for resolution. The rate of bleed- ing was also extremely low, seen in approximately 3% of cases of TEM and rarely required either transfusion or operative interven- tion. Postoperative fever, pelvic pain, and myocardial infarction have been reported but are also extremely rare. Throughout the literature, there is only one reported case of death directly follow- ing TEM. This patient died from septic shock 4 weeks following TEM excision of a rectal adenoma secondary to a retroperitoneal phlegmon.(23) With TEM surgery, there is always the possibility of rectal perforation, particularly with anteriorly located lesions. Major complications of perforation, wound dehiscence, and fistula formation have all been reported. Perforation with intraab- dominal contamination is a rare complication and is clearly both operator and patient dependent and may require conversion to an open operation for control. This can be especially problematic in the older female who may have undergone prior hysterectomy. Perforation in these patients may yield fistula formation. Wound dehiscence has been described but is also a rare, but potential complication. In a large review of 334 patients, a major complica- tion rate of 5.5% was cited. This included both intraperitoneal sepsis (n=3) and rectovaginal fistula (n=3).(24) The vast majority of TEM outcomes are reviewed in terms of oncologic results and complication rates. Remembering that one of the reasons for the promotion of less invasive procedures is sphincter preservation, some studies have analyzed continence and sphincter function postoperatively. Manometric studies of the anal sphincter have shown that the main risk for anal dysfunction after TEM is preoperative anal dysfunction. Additionally, other causes of postoperative anal dysfunction are advanced patient age, direct tumor involvement of the sphincter, postoperative internal sphincter defects, the extent and depth of tumor excision, loss of anal mucosa, and duration of the procedures. Sphincter function is affected by rectoanal perception and coordination, and electro- sensitivity of the anal mucosa—all of which are affected by TEM. Some patients also report an increase in bowel frequency which is likely related to decreased rectal compliance following reduc- tions in the overall rectal diameter from full-thickness or circum- ferential excisions.(22) Despite these reports, complication rates related to altered bowel habits remains exceedingly low (less than 2%) and the majority of these changes such as decreased resting pressures are seen during physiologic testing, but are not often clinically significant.(25, 26) TRANSANAL (TA) VS. TRANSANAL ENDOSCOPIC MICROSURGERY (TEM) Few reviews directly comparing the results of TA vs. TEM excision exist. Surgeons at the University of Vermont recently reviewed 171 patients treated between 1990 and 2005 by either traditional TA excision (n = 89) or TEM (n = 82) for rectal cancers.(27) During the course of their experience, they transitioned to the TEM technique in 2001, after which only 20 TA excisions took place. Although the results of seven surgeons were reviewed, only one performed all the TEM. The two populations were similar with respect to age, gender, lesion type, stage, and size with an overall mean follow-up of 37 months (significant difference in follow-up between the two groups due to their change to primarily TEM during the time period studied). All patients with T1 lesions with adverse features or T2 lesions received postoperative adju- vant therapy. Patients with T3 lesions underwent local excision only if they were considered too high risk for radical surgery or if they refused traditional resection. The decision to give patients with T3 lesions postoperative chemoradiation was made on an individualized basis. Postoperative complications among the TA and the TEM group were roughly equivalent (15% and 17%, respectively, p = 0.69) with the most common being urinary retention (6% and 7%, respectively). The TA group had six major complications including two anovaginal fistulae, one leak requiring an opera- tion, one bleed, one arrhythmia, and one patient who developed renal failure. The TEM group had two anovaginal fistulae and two leaks requiring operations. Overall, the difference between the two groups was not found to be significant. However, the patients who did undergo TEM enjoyed a significantly shorter hospital stay (0.6 days vs. 1.5 days). With regards to oncologic outcomes, 90% of the patients who underwent TEM had negative margins. TA patients had both a higher positive margin rate (15%) and indeterminate margin rate (15%) (p=0.001). Specimens were more likely to be removed intact rather than in a piece-meal fashion with TEM vs. TA (95% vs. 65%, p < 0.001). Lastly, local recurrence rates were dramatically improved with TEM (8% vs. 24%, p = 0.004) and such results were concordant with other ret- rospective reviews. Two-thirds of the local recurrences with TEM occurred after palliative resections defined as being T3 at the time of diagnosis or patients were either too ill to tolerate or refused a more radical operation. When considering only those TEM and TA cases performed with curative intent, the recurrence rate fell to 3% vs. 26% with transanal approaches (p = 0.06). No signifi- cant difference in distal recurrence was demonstrated (1% with TEM, 4% with TA). Although a criticism of the above data is the 6 improved outcomes in colon and rectal surgery disparity in follow-up between the two groups, most feel that the vast majority of recurrences will usually occur within the first 2 years and the mean follow-up for both groups was well beyond this time frame. With this, TEM appears to offer superior out- comes to TA in patients with T1 or T2 lesions with appropriate adjuvant therapies (Table 26.2).(27) THE CLEAR ADVANTAGES OF LOCAL SURGERY Although the oncologic advantages of TA or TEM excision of rec- tal cancers remain controversial in many circles, few can argue the benefits of pursuing a less invasive procedure. For patients whose medical comorbidities may place them at a higher or even unac- ceptable operative risk, TA or TEM approaches offer a solution that may confer acceptable oncologic outcomes as well. The same is true for those patients that have advanced disease but require palliation of symptoms. Patients with unresectable distant dis- ease, however, usually have large bulky primary tumors which are not amenable to transanal excision. Both LAR and APR are associated with significant morbidity and mortality which can be avoided with either TA or TEM excision in the appropriately selected patient. In patients who undergo traditional TA or TEM, the overall complication rates remain low and overall morbid- ity is minimal. A review of patients who had undergone TEM as compared with TME showed that although long-term quality of life was equal, patients who underwent TEM tended to have fewer defecation disorders, and, although not statistically significant, improved sexual function as well.(28) WHEN LOCAL SURGERY FAILS Following TA or TEM excision, aggressive surveillance is indicated to detect recurrent disease. The reason for both local and distal recurrence is not always clear, particularly in the face of what was considered early disease and in the absence of involved excisional margins. With regard to distant failure, occult disease may have been present at the time of initial presentation but not identified during the preoperative workup. In these instances, distant fail- ure is not due to presumed inadequate local treatment, but rather is a reflection of aggressive tumor biology. Local recurrence is more frequently related to the mesorectal disease rather than at the pelvic walls.(3) Additionally, fragmentation of the specimen at the time of excision and the inability to remove full thickness tissue during excision can predispose to local recurrence. In the presence of recurrent rectal cancer, there is currently no role for either TA or TEM from an oncologic perspective. Factors asso- ciated with an increased risk of local recurrence include those characteristics previously described as “high risk” which include poor differentiation and lymphovascular invasion, and of course, those whose excision is incomplete. Studies of patients that had undergone TEM for T1 and T2 lesions without evidence of lymph node metastasis found that patients who lesions carried the above characteristics had a significantly elevated risk of local recurrence necessitating salvage surgery.(29) Recurrent disease requires a TME by way of either an LAR or APR. Patients that undergo salvage TME have decreased survival when compared with their counterparts that had the operation as part of the initial management. In a study that evaluated patients who had initially undergone TA excision (n=155) for lesions with adverse histological characteristics and subsequently salvage APR (n=21), the disease free survival was only 56% vs. 94% for those who undergone immediate APR.(30) FUTURE DIRECTIONS OF STUDY Traditional TA surgery is evolving into TEM in many circles as surgeon familiarity and advanced laparoscopic skills become increasingly prevalent. Although TA is widely practiced by many, TEM confers the benefits of TA surgery with multiple clear clini- cal advantages. The indications for TEM will continue to increase in number as improved outcomes for more advanced disease are demonstrated throughout the literature. Sentinel lymphangiog- raphy may soon be applicable to colon and rectal cancer with potential TEM utilization. Additionally, with neoadjuvant thera- pies for advanced disease becoming increasingly effective in many patients, subjecting such patients to radical surgeries after their malignancies have often been reduced to a scar may prove to be unnecessarily aggressive, further opening the door to TEM and potential resection of the tissue that previously contained malig- nancy. Research into necessary tissue margins for TEM following such therapies is currently being undertaken. Although there will always be a role for traditional TME in the form of both LAR and APR procedures, the role of TA and TEM surgery continues to expand within the management of rectal cancer. REFERENCES 1. Whiteford MH. Transanal endoscopic microsurgery (TEM) resection of rectal tumors. J Gastrointest Surg 2007; 11(2): 155–7. 2. Nicholls RJ, Mason AY, Morson BC et al. The clinical staging of rectal cancer. Br J Surg 1982; 69(7): 404–9. 3. Bretagnol F, Rullier E, George B et al. 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Immediate vs. sal- vage resection after local treatment for early rectal cancer. Dis Colon Rectum 1995; 38(2): 177–81. . availability, and high  improved outcomes in colon and rectal surgery overall accuracy, many clinicians rely on TRUS in their standard preoperative work-up for rectal cancer and consider.  improved outcomes in colon and rectal surgery public and private initiative to develop standardized surveys of patients’ experiences with ambulatory and facility-level care.(86). local recurrence rates.  improved outcomes in colon and rectal surgery and low morbidity with virtually zero mortality. Winde was the first to demonstrate in a randomized prospective trial