Historically, investigation in colorectal surgery has focused on small, single-center series investigating optimal surgical techniques. Examples of such papers include reports on the “holy plane” in total mesorectal excision (see b, below), the Nigro protocol for squamous cell carcinoma of the anus (see a), and papers describing outcomes with various surgical techniques for inflammatory bowel disease. During the last decade, in an attempt to reduce postoperative length of stay, the research focus has shifted to the safety and outcomes of minimally invasive techniques in colorectal surgery. Results of these trials acknowledge the acceptability of laparoscopic-assisted resection for benign disease and for colon cancer, but potentially worse oncologic outcomes with this approach in cases of rectal cancer.
The last decade has also seen a growing movement to treat early rectal cancers with radiation and/or local excision, as an alternative to radical resection. Traditional proctectomy for the treatment of rectal cancer continues to generate controversy, given variable outcomes depending on surgeon experience and technique. Surgical treatment of diverticulitis continues to evolve, with management increasingly determined on a case-by-case basis. There are a multitude of clinical questions that remain to be answered, including the role of robotic surgery in colorectal operations, how we might improve rectal cancer outcomes, and whether radiation and/or local excision can safely replace radical resection for early rectal cancers. The following articles represent the best available data to inform current practice; however, any practitioner of colorectal surgery must review the literature frequently to keep abreast of this rapidly changing field.
An evaluation of combined therapy for squamous cell cancer of the anal canal.
Nigro ND
Diseases Colon Rectum. 1984;27(12):763–766.Takeaway Point: Chemoradiation therapy is the treatment of choice for squamous cell cancer of the anal canal, with abdominoperineal resection (APR) reserved for patients with persistent or recurrent disease.
Commentary: Prior to this trial, APR was the traditionally accepted management strategy for squamous cell carcinoma of the anal canal, with a 10-year survival rate of 52%. In the post–World War I era, British physicians began using radiation therapy as an alternative treatment, but the practice was discontinued because of toxicity. In the intervening years, radiation techniques advanced, and Dr. Nigro reports on the results of 104 patients who underwent combined chemotherapy and radiation for anal squamous cell carcinoma. He demonstrates complete clinical and pathologic response in most patients, with a low rate of severe toxicity. Largely as a result of this study, the standard of care for squamous cell carcinoma of the anal canal is now fluorouracil (5-FU), mitomycin, and radiation, often referred to as the “Nigro protocol,” with abdominoperineal resection undertaken only for residual or recurrent disease, or for palliation.
Introduction: When this article was published, the standard of care for anal squamous cell cancer was abdominoperineal resection. Radiation as primary therapy was known to be effective, but had unacceptable complications. Advancements in more targeted techniques and concomitant chemotherapy with lower radiation doses reopened the door for nonoperative primary therapy.
Objectives: To evaluate the effects of radiation and chemotherapy in patients with squamous cell carcinoma of the anal canal.
Trial Design: Multicenter, nonrandomized, prospective case series.
Inclusion Criteria: Patients presenting to the author’s institution with anal canal squamous cell carcinoma, as well as additional patients from other institutions via questionnaires.
Exclusion Criteria: Distant metastases at diagnosis, patients already included in other publications.
Intervention: External irradiation of 30 Gy to the primary tumor, pelvic and inguinal nodes over 21 days. Mitomycin C bolus (15 mg/m2) on day 1, then 5-fluorouracil (1000 mg/m2) continuously over days 1–4 and 28–31. Initial protocol included APR at 6 weeks after therapy, but after five of the first six patients were found to have no tumor in the operative specimen, the protocol was changed and abdominoperineal resection was not performed unless there was residual tumor.
Primary Endpoint: Presence of tumor following chemoradiation.
Secondary Endpoints: Survival, toxicity from chemoradiation.
Sample Size: From 1972 to 1982, 104 patients were included, 44 from the author’s institution and 60 from other institutions.
Statistical Analysis: None (only raw data presented).
Baseline Data: 76 women and 28 men were included, with age ranging from 32 to 80 years. Initial tumor size ranged from 2 to 8 cm. Four had inguinal node metastases at diagnosis.
Outcomes: There was no residual gross tumor after chemoradiation in 97 of 104 patients; the seven with gross tumor still present all had initial tumors ≥5 cm. A total of 31 patients underwent abdominoperineal resection. Of the 24 without gross tumor who still underwent APR, only two specimens had microscopic disease. An additional seven patients underwent abdominoperineal resection for recurrent disease in the 3–12 months after chemoradiation. At follow-up of 2–11 years, 82 patients were disease-free; 60 of these patients had undergone only chemoradiation. Of the 20 deaths, 13 were attributable to disease progression. Five patients experienced severe adverse effects of chemoradiation requiring hospitalization.
Conclusion: Chemoradiation alone is safe and effective for anal squamous cell cancer. Abdominoperineal resection should be performed for those with residual or recurrent disease.
Limitations: This is a small single-arm series with variable treatment protocols. No comparison group is presented, and only raw data are reported. The majority of patients were treated at outside centers and data was obtained by questionnaire only.
Recurrence and survival after total mesorectal excision for rectal cancer.
Heald RJ, Ryall RD
Lancet 1986;1(8496):1479–1482.Takeaway Point: Low anterior resection for distal and midrectal adenocarcinomas has low rates of local recurrence when paired with complete excision of the mesorectum.
Commentary: Total mesorectal excision (TME) was first described in the 1930s, but Heald is responsible for promoting it as the standard surgical technique for proctectomy for rectal cancer. Noting the unsettling wide variations in local recurrence for rectal cancer, Heald surmised that a potential risk factor is failure to dissect within the avascular plane between the fascia propria of the rectum and the presacral fascia, thus maintaining the integrity of the mesorectal envelope. In this article, he describes excellent oncologic outcomes with few local recurrences in his personal series of 115 rectal cancer patients undergoing low anterior resection. He demonstrates that a wide mural margin does not provide additional oncologic benefit; hence, abdominoperineal excision with permanent end colostomy is not mandatory for low rectal cancers that are amenable to restorative proctectomy. The significance of this work is twofold; it emphasized the importance of sharp dissection within the presacral plane during proctectomy, and it demonstrated that restorative proctectomy for low rectal cancer is oncologically sound. These tenets have led to great advances in the surgical care of rectal cancer patients, reducing both local recurrence and permanent colostomy.
Introduction: The introduction of new stapling devices in the 1980s allowed for more distal colorectal anastomoses after proctectomy, but a distal mural margin of at least 5 cm was still considered oncologically necessary. However, extrarectal tumor spread was hypothesized to occur first within the mesorectum, raising the possibility that a smaller mural margin with total excision of the mesorectum might decrease the need for abdominoperineal excision.
Objectives: To examine the local control of rectal cancer using the surgical technique of total mesorectal excision with a reduction of the bowel wall margin.
Trial Design: Prospective consecutive single-surgeon series.
Inclusion Criteria: Patients with rectal or anal adenocarcinoma with the distal edge ≤15 cm from the anal verge undergoing curative anterior resections, with anus not palpably invaded by tumor where a clamp can be placed across the bowel distal to the tumor.
Exclusion Criteria: Patients with malignant polyps, carcinomas associated with polyposis or colitis, or undergoing palliative resection.
Intervention: Anterior resection of the rectum using a standard surgical technique consisting of proximal ligation of the inferior mesenteric vessels, sharp dissection under direct vision in the avascular plane between the visceral mesorectum and the somatic structures (autonomic nerve plexuses), widely placed peritoneal incisions to include the entire peritoneal reflection, and division of the middle rectal vessels far from the carcinoma. This allows the surgeon to free the rectum and mesorectum from the levators, thus preserving a small rectal reservoir devoid of visceral tissue that can be used for colorectal anastomosis.
Endpoints: 5-year overall and disease-free survival.
Sample Size: 115 rectal cancer patients referred for curative anterior resection at a single hospital with a policy of referring all rectal carcinomas to a single surgical firm from July 1978 to January 1986.
Statistical Analysis: Kaplan–Meier survival analysis, with corrected cumulative probability incorporating a predictive factor for patients followed for <5 years, and comparison of life tables by the log-rank test.
Baseline Data: Of the 188 patients referred, 11% underwent abdominoperineal excision with end colostomy and 19% underwent palliative operations. Of the 115 patients undergoing curative restorative proctectomy, over 85% had mural resection margins <5 cm.
Outcomes: 30-day mortality was 2.6%. There were three pelvic recurrences and no staple line recurrences. The cumulative risk of local recurrence on the life table was 3.7%. The corrected cumulative survival probability at 5 years was 87.5%, overall tumor-free survival at 5 years was 81.7%, and the tumor-free survival by Dukes stage was: A 94%; B 87%; and C 58%. The height of anastomosis and length of mural margin did not influence survival.
Conclusion: Total mesorectal excision during proctectomy for rectal cancers not only eliminates the difference in prognosis between proximal and distal rectal cancers and improves local recurrence rates but also allows for reduced mural margins and thus greater rates of sphincter preservation.
Limitations: The lack of a control group precludes comparison, and the use of a single surgeon’s case series leads to lack of generalizability. The rates of survival and recurrence are a combination of actual and projected data. All analyses were univariate, and do not control for patient factors.
Quality of life after total colectomy with ileorectal anastomosis or proctocolectomy and ileal pouch–anal anastomosis for familial adenomatous polyposis.
Van Duijvendijk P, Slors JF, Taat CW, Oosterveld P, Sprangers MA, Obertop H, Vasen HF
Br J Surg. 2000;87(5):590–596.Takeaway Point: Patients with familial adenomatous polyposis who undergo total colectomy with ileorectal anastomosis versus total proctocolectomy with ileal pouch–anal anastomosis have largely comparable quality-of-life scores.
Commentary: The two surgical options for the treatment of familial adenomatous polyposis (FAP) are total colectomy with ileorectal anastomosis (IRA) and total proctocolectomy with ileal pouch-anal anastomosis (IPAA). A common assumption is that quality of life (QOL) outcomes with IPAA are much worse than with IRA. This may cause patients and physicians to choose IRA over IPAA, despite the fact that half of patients who undergo IRA will eventually require completion proctectomy due to rectal polyposis or cancer. This study sought to compare the QOL outcomes of FAP patients who have undergone IRA and IPAA. The authors found that the two groups were similar in all subscales of a generic QOL questionnaire, and all subscales of a disease-specific QOL scale, with the exception of worse defecation problems in the IPAA group. The demonstration of largely equivalent QOL outcomes between these two procedures is an important consideration in the process of shared decision-making for surgical intervention in patients with FAP.
Introduction: FAP patients develop hundreds of colon polyps, and colorectal cancer by age 40 if left untreated. Half of patients who undergo total colectomy with ileorectal anastomosis (IRA) will later require completion proctectomy for rectal polyps or cancer. Thus, more patients are choosing the more definitive, although technically more complex, total proctocolectomy with ileal pouch–anal anastomosis (IPAA) to remove all at-risk colorectal mucosa. Postoperative QOL is an important consideration for patients with FAP faced with this decision.
Objectives: To compare the QOL between FAP patients with an ileorectal anastomosis and an ileal pouch–anal anastomosis.
Trial Design: Cross-sectional study with age- and sex-matched controls.
Inclusion Criteria: Patients with FAP in a registry established by the Netherlands Foundation for the Detection of Hereditary Tumors, and a randomly selected group of age- and sex-matched normal controls.
Exclusion Criteria: Questionnaire nonresponders.
Intervention: Patients who underwent IRA or IPAA for FAP received the generic Short Form-36 Health Survey (SF-36) and the disease-specific European Organization for Research and Treatment of Cancer Colorectal Quality of Life Questionnaire (EORTC QLQ-CR38).
Endpoints: Generic and disease-specific QOL.
Sample Size: Of 323 eligible FAP registry patients, 279 (86%) responded; 183 patients who underwent IRA between 1961–1996 and 140 patients who underwent IPAA between 1984–1996. A control group of 279 of healthy volunteers completed the SF-36.
Statistical Analysis: The surgical groups were compared with the control group using univariate and multivariate analysis of variance, including the effect of sex, comorbidity, conversion from IRA to IPAA, age at survey, age at operation, length of follow-up, and IPAA anastomotic technique.
Baseline Data: IRA patients were older (mean age 41 vs. 37) and had a longer follow-up period (12 vs. 6.8 years).
Outcomes: There were no differences between the IRA and IPAA patients for all subscales of the generic QOL questionnaire, and both FAP groups had significantly poorer scores on all subscales than did the general population control group. The disease-specific QOL questionnaire showed more defecation problems in the IPAA group, but otherwise no difference in domains of body image, sexual function, gastrointestinal tract problems, micturition, and future perspective. Controlling for sex, comorbidities, conversion of IRA to IPAA, current age, and age at time of operation did not change the results.
Conclusion: In most QOL domains, FAP patients who undergo IRA vs IPAA do not differ, except that the latter group reported more defecation problems. Both FAP groups have significantly lower QOL outcomes than age-matched controls in the general population.
Limitations: Limitations are inherent to a cross-sectional study capturing patients at different time points from surgery.
(1) Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer.
Kapiteijn E, Marijnen CA, Nagtegaal ID, Putter H, Steup WH, Wiggers T, Rutten HJ, Pahlman L, Glimelius B, van Krieken JH, Leer JW, van de Velde CJ, Dutch Colorectal Cancer Group
NEJM. 2001;345(9):638–646.(2) Preoperative radiotherapy combined with total mesorectal excision for resectable rectal cancer: 12-year follow-up of the multicentre, randomised controlled TME trial.
van Gijn W, Marijnen CA, Nagtegaal ID, Kranenbarg EM, Putter H, Wiggers T, Rutten HJ, Påhlman L, Glimelius B, van de Velde CJ, Dutch Colorectal Cancer Group
Lancet Oncol. 2011;12(6):575–582.Takeaway Point: A short course of preoperative radiation therapy prior to total mesorectal excision improves the local recurrence rate, but not overall survival, in patients with rectal adenocarcinoma.
Commentary: This trial was conducted to determine whether preoperative radiation therapy improved oncologic outcomes in patients with rectal cancer. The authors found that short-term preoperative radiation therapy improves local control of rectal cancer compared to total mesorectal excision (TME) alone. The long-term outcomes demonstrate that 10-year local recurrence is reduced by over 50% in patients who undergo preoperative short-term radiotherapy compared to those who do not. These papers definitively established the standard of care for nonmetastatic rectal cancer: preoperative radiotherapy followed by TME. This trial followed strict quality control guidelines for radiation therapy, surgical technique, and detection of recurrence. Such results may not be representative of other centers with more variation in the delivery of radiation and in surgical technique and experience. This trial used short-course radiotherapy (5 Gy daily for 5 days) followed by TME. More common in the United States is long-course chemoradiotherapy (28 sessions over 5½ weeks for a total of 54 Gy), then TME 6–12 weeks later. Long-course chemoradiotherapy may be of particular benefit for shrinking large distal rectal tumors to make a sphincter-saving operation feasible, and short-course chemoradiotherapy is well suited to patients with metastatic disease who have already undergone upfront systemic chemotherapy, but thus far no trial has compared the two options directly.
Introduction: Preoperative radiotherapy and total mesorectal excision have both been shown to improve local recurrence rates of rectal cancer, but prior studies have not standardized a combination surgical and radiotherapy regimen.
Objectives: To investigate the efficacy of preoperative radiotherapy in combination with standardized total mesorectal excision in patients with rectal cancer.
Trial Design: Multicenter, randomized, prospective trial.
Inclusion Criteria: Patients with histologically confirmed rectal adenocarcinoma, with the distal tumor margin within 15 cm from the anal verge and below S1–2.
Exclusion Criteria: Distant metastases, fixed tumors, tumors treated by transanal excision, coexisting or prior history of cancer, prior chemotherapy or pelvic radiotherapy, prior colon surgery.
Intervention: The intervention group underwent radiotherapy to the primary tumor (5 Gy for 5 days), followed by total mesorectal excision, while the control group underwent surgery alone. Follow-up occurred every 3 months for 1 year, then annually for at least 2 years, with annual endoscopy and liver imaging. Participating surgeons were proctored for standard surgical technique. Pathologists used a uniform protocol, and a panel reviewed the specimens.
Primary Endpoint: Survival.
Secondary Endpoints: Local recurrence (tumor in the lesser pelvis or perineal wound), distant recurrence (tumor in any other area).
Sample Size: From January 1996 to December 1999, 1805 patients were enrolled from 84 Dutch, 13 Swedish, and 11 other European and Canadian institutions; 924 radiotherapy plus surgery and 937 surgery alone.
Statistical Analysis: χ2 tests to compare proportions, Mann–Whitney tests to compare quantitative and ordinal variables, Kaplan–Meier method to measure survival, log-rank test to evaluate differences between the two groups, Cox proportional-hazards model to determine hazard ratios in the univariate and multivariate analyses.
Baseline Data: Of the 1805 patients, 1653 had a curative resection, 57 did not have a macroscopically complete local resection, and 95 were found to have distant metastases intraoperatively. There was no tumor present in 28 specimens. The two groups were similar in age, gender, tumor location, operation type, and stage.
Outcomes: Survival at 2 years was comparable between the intervention and control arms (82% vs. 81.8%). Local recurrence rate at 2 years was lower in the intervention group [2.4% vs. 8.2%, hazard ratio (HR) 3.42]. Independent predictors of local recurrence were lack of preoperative radiotherapy, distance of the tumor from the anal verge, and TNM stage. Univariate subgroup analysis demonstrated that preoperative radiotherapy reduced local recurrence risk if the inferior margin was ≤10 cm from the anal verge, and for stage 2 and 3 disease, although this was not seen in the multivariate analysis. There was no difference in the risk of distant or overall recurrence. The intervention group had greater intraoperative blood loss (1000 vs. 900 mL), and those undergoing abdominoperineal resection after radiotherapy had more perineal wound complications (26% vs. 18%).
Conclusion: Radiotherapy before total mesorectal excision improves local control of rectal cancer compared to surgical resection alone, but does not improve overall survival.
Limitations: Relatively short follow-up to adequately determine overall survival.
‘Fast track’ postoperative management protocol for patients with high comorbidity undergoing complex abdominal and pelvic colorectal surgery.
Delaney CP, Fazio VW, Senagore AJ, Robinson B, Halverson AL, Remzi FH
Br J Surg. 2001;88(11):1533–1538.Takeaway Point: A “fast track” recovery protocol can shorten hospital length of stay after major abdominal or pelvic surgery, even for patients with comorbidities.
Commentary: “Fast track” protocols to enhance postoperative recovery have been widely studied, but had previously focused on uncomplicated operations in relatively healthy patients. This study examines the use of a multimodal care plan to enhance recovery after complex colorectal operations in patients with and without comorbidities. During a 6-week time period, consecutive patients on one of several colorectal services at a single institution were assigned to this “fast track” pathway. The authors demonstrated that this group had a shorter length of stay than patients on other colorectal services during the same time period, at the same institution. Patients with comorbidities stayed a day longer than those without. The readmission rate remained low. This article demonstrates that enhanced postoperative recovery pathways can be safely applied to more complicated patients without incurring harm or higher readmission rates.
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