Assessing the Quality of Rectal Cancer Pathology Reports in National Surgical Adjuvant Breast and Bowel Project Protocol R-04/NRG Oncology.

BACKGROUND: Accurate and comprehensive surgical pathology reports are integral to the quality of cancer care. Despite guidelines from the College of American Pathologists, variations in reporting quality continue to exist. OBJECTIVE: The aim of this study was to evaluate the quality of rectal cancer pathology reports and to identify areas of deficiency and potential sources of reporting variations. DESIGN: This is a retrospective analysis of prospectively obtained pathology reports. SETTING: This study is based at the hospitals participating in the National Surgical Adjuvant Breast and Bowel Project Protocol R-04 study. PATIENTS: Patients with rectal cancer undergoing surgical resection between July 2004 and August 2010 were included. MAIN OUTCOME MEASURES: The primary outcomes measured were the adherence to the College of American Pathologists guidelines and the impact of synoptic reporting, academic status, rural/urban setting, and hospital bed size on reporting quality. RESULTS: We identified 1004 surgical pathology reports for rectal cancer surgery from 383 hospitals and 755 pathologists. The overall adherence rate to the College of American Pathologists guidelines was 73.3%. Notable reporting deficiencies were found in several key pathology characteristics, including tumor histologic grade (reporting rate 77.8%), radial margin (84.6%), distance from the closest margin (47.9%), treatment effect (47.1%), and lymphovascular (73.1%)/perineural invasions (35.4%). Synoptic reporting use and urban hospital settings were associated with better adherence rates, whereas academic status and hospital bed size had no impact. Reporting variations existed not only between institutions, but also within individual hospitals and pathologists. There was a trend for improved adherence over time (2005 = 65.7% vs 2010 = 82.3%, p < 0.001), which coincided with the increased adoption of synoptic reporting by pathologists (2005 vs 2010, 9.4% vs 25.3%, p < 0.001). LIMITATIONS: Data were obtained from a restricted setting (ie, hospitals participating in a randomized clinical trial). CONCLUSIONS: Wide variations in the quality of pathology reporting are observed for rectal cancer. The National Accreditation Program for Rectal Cancer mandates that programs meet strict quality standards for surgical pathology reporting. Further improvement is needed in this key aspect of oncology care for patients with rectal cancer. See Video Abstract at http://links.lww.com/DCR/B238.ClinicalTrials.gov registration: NCT00058 EVALUACIÓN DE LA CALIDAD DE LOS INFORMES DE PATOLOGÍA QUIRÚRGICA EN CASOS DE CÁNCER DE RECTO DEL NSABP R-04/ ONCOLOGÍA DEL NRG: Un informe de patología quirúrgica preciso y completo es fundamental en la calidad de atención de pacientes con cáncer. A pesar de las normas establecidas por el Colegio Americano de Patología, la variabilidad en la calidad de los informes es evidente.Evaluar la calidad de los informes de patología en casos de cáncer de recto para así identificar las áreas con deficiencias y las posibles fuentes variables en los mencionados informes.Análisis retrospectivo de informes de patología quirúrgica obtenidos prospectivamente.Hospitales que participan del Protocolo del Estudio Nacional R-04 como Adyuvantes Quirúrgicos de Mama e Intestino.Todos aquellos pacientes con cáncer de recto sometidos a resección quirúrgica entre Julio 2004 y Agosto 2010.Cumplimiento de las normas del Colegio Americano de Patología, del impacto de los informes sinópticos, del estado académico, del entorno rural / urbano y el número de camas hospitalarias en en la calidad de los informes.Identificamos 1,004 informes de patología quirúrgica en casos de cirugía en cáncer de recto en 383 hospitales y 755 patólogos. La tasa general de adherencia a las directivas del Colegio Americano de Patología fue del 73.3%. Se encontraron deficiencias notables en los informes en varias características patológicas clave incluidos, el grado histológico del tumor (tasa de informe 77.8%), margenes radiales (84.6%), distancia del margen más cercano (47.9%), efecto del tratamiento (47.1%) invasión linfovascular (73.1 %) / invasion perineural (35.4%). El uso de informes sinópticos y los entornos hospitalarios urbanos se asociaron con mejores tasas de adherencia, mientras que el estado académico y el número de camas hospitalarias no tuvieron ningún impacto. Hubo variaciones en los informes no solo entre instituciones, sino también dentro de hospitales y patólogos individuales. Hubo una tendencia a una mejor adherencia a lo largo del tiempo (2005 = 65.7% v 2010 = 82.3%, p < 0.001), que coincidió con la mayor adopción de informes sinópticos por parte de los patólogos (2005 v 2010, 9.4% v 25.3%, p < 0.001)Datos obtenidos de un entorno restringido (es decir, hospitales que participan en un ensayo clínico aleatorizado).Se observaron grandes variaciones en la calidad de los informes de patología quirúrgica en casos de cáncer de recto. El Programa Nacional de Acreditación para Cáncer de Recto exige que los programas cumplan con estrictos estándares de calidad para los informes de patología quirúrgica. Se necesita una mejoría adicional en este aspecto clave de la atención oncológica para pacientes con cáncer de recto. Video Resumen en http://links.lww.com/DCR/B238.Registro de Clinical Trials.gov: NCT00058.

Comparative effectiveness of sphincter-sparing surgery versus abdominoperineal resection in rectal cancer: patient-reported outcomes in National Surgical Adjuvant Breast and Bowel Project randomized trial R-04.

OBJECTIVE: National Surgical Adjuvant Breast and Bowel Project (NSABP) R-04 was a randomized controlled trial of neoadjuvant chemoradiotherapy in patients with resectable stage II-III rectal cancer. We hypothesized that patients who underwent abdominoperineal resection (APR) would have a poorer quality of life than those who underwent sphincter-sparing surgery (SSS). METHODS: To obtain patient-reported outcomes (PROs) we administered two symptom scales at baseline and 1 year postoperatively: the Functional Assessment of Cancer Therapy-Colorectal (FACT-C) and the European Organization for the Research and Treatment of Cancer module for patients with Colorectal Cancer Quality of Life Questionnaire (EORTC QLQ-CR38). Scoring was stratified by nonrandomly assigned definitive surgery (APR vs SSS). Analyses controlled for baseline scores and stratification factors: age, sex, stage, intended surgery, and randomly assigned chemoradiotherapy. RESULTS: Of 1,608 randomly assigned patients, 987 had data for planned analyses; 62% underwent SSS; 38% underwent APR. FACT-C total and subscale scores were not statistically different by surgery at 1 year. For the EORTC QLQ-CR38 functional scales, APR patients reported worse body image (70.3 vs 77.0, P = 0.0005) at 1 year than did SSS patients. Males undergoing APR reported worse sexual enjoyment (43.7 vs 54.7, P = 0.02) at 1 year than did those undergoing SSS. For the EORTC QLQ-CR38 symptom scale scores, APR patients reported worse micturition symptoms than the SSS group at 1 year (26.9 vs 21.5, P = 0.03). SSS patients reported worse gastrointestinal tract symptoms than did the APR patients (18.9 vs 15.2, P < 0.0001), as well as weight loss (10.1 vs 6.0, P = 0.002). CONCLUSIONS: Symptoms and functional problems were detected at 1 year by EORTC QLQ-CR38, reflecting different symptom profiles in patients who underwent APR than those who underwent SSS. Information from these PROs may be useful in counseling patients anticipating surgery for rectal cancer.

Preoperative versus postoperative radiotherapy for rectal cancer in a decision analysis and outcome prediction model.

PURPOSE: Reduction of local recurrences has been achieved by radiotherapy, but also by improved surgical technique (total mesorectal excision). Radiotherapy has adverse effects and cannot exceed local dose limits. Neoadjuvant radiotherapy may result in overtreatment. We aimed to define the minimum local benefit that would have to be postulated for radiotherapy in order to bring a benefit to the overall cohort. We hypothesized that saving radiotherapy as treatment for a subset of patients with high-risk tumors and local recurrences improves the outcome of the overall cohort. We sought to simulate preoperative versus postoperative radiotherapy in theoretical decision analysis model based on published recurrence rates, with overall survival being the primary end point. METHODS: Computerized literature search for studies published between 1996 and 2011, supplemented by manual review of the retrieved reference lists. RESULTS: Postoperative radiotherapy evolved as preferred strategy with cure rates of 65.6 % vs. 63.7 % for postoperative and neoadjuvant radiotherapy, respectively, and a decrease of radiation exposure to 42.9 % of the cohort. The system was sensitive to (1) the fraction of stage I cancers included in the cohort, (2) the difference between local recurrence rates (LRR) for neoadjuvant radiotherapy, adjuvant radiotherapy, or surgery-only approach, and (3) the compliance with the postoperative radiotherapy. If the surgery-only recurrence was set to the published 10 %, 13 %, and 27 %, respectively, adjuvant radiotherapy had to achieve LRR below the threshold values of 6.3 %, 8.5 %, and 18.3 % to reverse the impact of compliance. CONCLUSIONS: Radiotherapy only improves cancer-specific survival of the cohort if there is a large difference in LRR with versus without it. Routine treatment may therefore be inferior to a tailored radiotherapy regimen.

Long-term follow-up and individual item analysis of quality of life assessments related to laparoscopic-assisted colectomy in the COST trial 93-46-53 (INT 0146).

BACKGROUND: Postoperative outcomes of patients undergoing laparoscopic-assisted colectomy (LAC) have shown modest improvements in recovery but only minimal differences in quality of life (QOL) compared with open colectomy. We therefore sought to assess the effect of LAC on QOL in the short and long term, using individual item analysis of multi-item QOL assessments. METHODS: QOL variables were analyzed in 449 randomized patients from the COST trial 93-46-53 (INT 0146). Both cross-sectional single-time and change from baseline assessments were run at day 2, week 2, month 2, and month 18 postoperatively in an intention-to-treat analysis using Wilcoxon rank-sum tests. Stepwise regression models were used to determine predictors of QOL. RESULTS: Of 449 colon cancer patients, 230 underwent LAC and 219 underwent open colectomy. Subdomain analysis revealed a clinically moderate improvement from baseline for LAC in total QOL index at 18 months (P = 0.02) as well as other small symptomatic improvements. Poor preoperative QOL as indicated by a rating scale of ≤ 50 was an independent predictor of poor QOL at 2 months postoperatively. QOL variables related to survival were baseline support (P = 0.001) and baseline outlook (P = 0.01). CONCLUSIONS: Eighteen months after surgery, any differences in quality of life between patients randomized to LAC or open colectomy favored LAC. However, the magnitude of the benefits was small. Patients with poor preoperative QOL appear to be at higher risk for difficult postoperative courses, and may be candidates for enhanced ancillary services to address their particular needs.

Surveillance after colorectal cancer resection: a systematic review.

BACKGROUND: Surveillance programs are widely accepted as an integral part of the treatment plan provided to patients after surgical treatment of colorectal cancer. Despite an enormous amount of research performed regarding these programs, there is still uncertainty regarding what is appropriate surveillance. OBJECTIVE: We sought to systematically review recent literature regarding outcomes achieved with different types of surveillance programs for patients with surgically treated colorectal cancer. DATA SOURCES: A search of the PubMed database was performed to identify studies published in the English language between January 2000 and January 2010. STUDY SELECTION: We included 2 types of studies in our systematic review: first, comparative studies where 2 or more surveillance strategies were applied and outcomes compared; second, single-cohort studies where the outcomes of a single surveillance strategy were reported. MAIN OUTCOME MEASURES: Cancer-related outcomes included survival, recurrence detection rate, and the ability of a recurrence to be resected with curative intent. RESULTS: Our review found 15 studies meeting our inclusion criteria. Of these, 9 were comparative (4 randomized trials) and 6 were single-cohort studies. One study reported a better survival rate among patients who received more intensive follow-up. The vast majority of recurrences occurred within 3 years. LIMITATIONS: Our review found that the recent literature regarding the efficacy of surveillance is inconclusive, largely because of the small sample sizes and the heterogeneity in the surveillance programs and outcomes reported. CONCLUSIONS: Future randomized trials need to focus on larger sample sizes, and experimental designs should isolate specific elements of surveillance to better understand how each element contributes to improvements in patient outcomes. Risk stratification and duration of surveillance are key elements of surveillance strategies that also deserve focused investigation.

Colorectal procedures: what proportion is performed by American board of colon and rectal surgery-certified surgeons?

PURPOSE: The surgical workforce within the United States is moving rapidly toward increasing subspecialization. We hypothesized that over time an increasing proportion of colorectal procedures is performed by subspecialty-trained colorectal surgeons. METHODS: We used data from the Surveillance, Epidemiology, and End Results-Medicare program to examine the treatment of patients who underwent a colorectal surgical procedure between 1992 and 2002. We established whether the surgeon responsible for the patient's initial care was a board-certified colorectal surgeon based on a linkage with 2 overlapping data sources: 1) historical data from the American Board of Colon and Rectal Surgery and 2) the American Medical Association Physician Masterfile. RESULTS: We examined a total of 104,636 procedures; overall, 30.6% of anorectal procedures, 22.0% of proctectomies, 14.0% of ostomy-related procedures, and 11.5% of colectomies were performed by board-certified colorectal surgeons. Procedures in regions with lower population density or during urgent/emergent hospitalizations were more likely to be performed by a noncolorectal surgeon. Operations for cancer and those performed on an elective basis were more likely to be performed by a board-certified colorectal surgeon. Over time, the proportion of each of these types of cases performed by a colorectal surgeon increased. This increase was fastest for anorectal procedures. CONCLUSIONS: During the 11-year period of our study, there was a significant increase in the proportion of colorectal surgical procedures performed by board-certified colorectal surgeons.

Diverticulitis in the United States: 1998-2005: changing patterns of disease and treatment.

OBJECTIVES: Diverticular disease imposes an impressive clinical burden to the United States population, with over 300,000 admissions and 1.5 million days of inpatient care annually. Consensus regarding the treatment of diverticulitis has evolved over time, with increasing advocacy of primary anastomosis for acute diverticulitis, and nonoperative treatment of recurrent mild/moderate diverticulitis. We analyzed whether these changes are reflected in patterns of practice in a nationally-representative patient cohort. METHODS: We used the 1998 to 2005 nationwide inpatient sample to analyze the care received by 267,000 patients admitted with acute diverticulitis, and 33,500 patients operated electively for diverticulitis. Census data were used to calculate population-based incidence rates of disease and surgical treatment. Weighted logistic regression with cluster adjustment at the hospital level was used for hypothesis testing. RESULTS: Overall annual age-adjusted admissions for acute diverticulitis increased from 120,500 in 1998 to 151,900 in 2005 (26% increase). Rates of admission increased more rapidly within patients aged 18 to 44 years (82%) and 45 to 74 years (36%). Elective operations for diverticulitis rose from 16,100 to 22,500 per year during the same time period (29%), also with a more rapid increase (73%) in rates of surgery for individuals aged 18 to 44 years. Multivariate analysis found no evidence that primary anastomosis is becoming more commonly used. CONCLUSIONS: We are the first to report dramatic changes in rates of treatment for diverticulitis in the United States. The causes of this emerging disease pattern are unknown, but certainly deserve further investigation. For patients undergoing surgery for acute diverticulitis, there was little change over time in the likelihood of a primary anastomosis.

Impact of the aging population on the demand for colorectal procedures.

PURPOSE: With the baby boomers entering retirement age, the United States population is seeing a dramatic increase in the number of elderly individuals. We hypothesized that as a result, during the next 20 years, the demand for colorectal procedures will grow rapidly. METHODS: We used the 2005 Nationwide Inpatient Sample and the Florida State Ambulatory Surgery Database as source data. From these two data sources, we identified commonly performed inpatient and outpatient colorectal procedures, as well as associated diagnoses. These data were combined with census projections to generate projected volumes for the selected procedures and diagnoses. RESULTS: Between 2005 and 2025, the United States population is expected to grow by 18 percent, with disproportionate growth in individuals aged 65 to 74 years (92 percent) and those aged 75+ years (54 percent). We forecast that growth in outpatient procedures and inpatient procedures will be 21.3 percent and 40.6 percent, respectively. Inpatient operations for colon cancer and rectal cancer show the greatest growth. CONCLUSIONS: During the next two decades, demographic changes in the United States population will lead to a marked increase in the use of colorectal surgical services, especially inpatient and oncologic procedures. The ability of the surgical workforce to meet this projected growth in demand should be assessed.

Adenocarcinoma arising in the middle of ileoanal pouches: report of five cases.

Restorative proctocolectomy with ileal pouch-anal anastomosis with or without mucosectomy has become the procedure of choice in patients with long-standing ulcerative colitis complicated by malignancy or medically refractory disease and for familial polyposis syndrome. Some reports have demonstrated the development of malignancy at the ileoanal anastomosis. We present a recent series of five patients who developed adenocarcinoma in the middle of their ileal pouch including the first case of pouch carcinoma in a patient who underwent pouch formation for ulcerative colitis. We discuss their presentation and management. Development of ileal pouch cancers, while rare, has been seen with increasing frequency in our practice. Patients with long-standing ileal pouches may benefit from routine surveillance of the pouch as often as every six months, which can be performed quickly and easily in the office using flexible endoscopy.

Inflammatory bowel disease in the United States from 1998 to 2005: has infliximab affected surgical rates?

The treatment costs for patients in the United States with inflammatory bowel disease (IBD) exceed 1.7 billion dollars/year. Infliximab, an antibody to tumor necrosis factor-alpha has been extensively used to treat IBD, with 390,000 IBD patients receiving the drug since its FDA approval in 1998. We sought to determine the impact of infliximab on population-based rates of hospitalizations and surgical care for patients with IBD in the United States. We used data from the Nationwide Inpatient Sample to analyze patterns of hospital-based treatment provided to patients with IBD between 1998 and 2005. Data from this analysis were combined with census data to calculate trends in population-based rates of treatment. Overall rates of hospitalization for patients with Crohn's disease and ulcerative colitis increased significantly between 1998 and 2005 (5.1%/year and 3.4%/year respectively, P < 0.001 for each). During the same time period there were no changes in the overall rates of surgical care. The expanding use of infliximab has not significantly impacted the use of surgical procedures for patients with either ulcerative colitis or Crohn's disease, and rates of nonsurgical hospitalizations have actually increased. Even in the era of infliximab, surgical care remains a mainstay in the treatment of IBD.

Diverticulitis in California from 1995 to 2006: increased rates of treatment for younger patients.

Colonic diverticular disease is responsible for over 300,000 admissions and expenditures exceeding $2.7 billion/year. There is recent evidence that rates of treatment for diverticulitis have increased in the United States over the last decade. We hypothesize that these national trends of increasing rates of hospitalizations for diverticulitis would be found in an analysis of a single-state discharge database. Data from the Office of Statewide Health Planning and Development were used to analyze treatment for diverticulitis in California from 1995 to 2006. For each hospitalization, surgical care was determined based on procedure codes for left colon resection and/or colostomy. Overall numbers of admissions for acute diverticulitis increased throughout the 12-year study period with an estimated annual percentage of change (EAPC) of 2.1 per cent (P < 0.001). Rates of admissions increased most rapidly in patients 20 to 34-years-old (EAPC = 8.6%, P < 0.001) and 35 to 49 years old (EAPC = 5.7%, P < 0.001). Elective colectomies had an EAPC of 2.1 per cent (P < 0.001), which was also most dramatic in younger age groups. Between 1995 and 2006 we found significant increases in both the rates of hospitalization for diverticulitis and rates of elective surgical treatment in California. These increases are entirely due to higher rates of care for younger patients.

Prevalence of intra-abdominal surgery: what is an individual's lifetime risk?

BACKGROUND: The lifetime risk of intra-abdominal surgery is unknown. The objectives of this study were to derive this information from our local population, and to consider the role of incidental surgery. METHODS: Over an 8-year period, 2648 autopsy and clinical records from a public and private hospital were reviewed for evidence of intra-abdominal surgery. RESULTS: 2262 (85%) cases were from the public hospital and 386 (15%) from the private hospital. The adjusted intra-abdominal surgical rate was 43.8% in those over the age of 60. With the exception of the age group 21-40, there were no statistical significant differences in operative rates between hospitals. The intra-abdominal surgical rate over the age of 60 was used as an estimate of the lifetime risk of intra-abdominal surgery. CONCLUSIONS: The lifetime risk of intra-abdominal surgery can be used to assess the utilization of healthcare among ethnic groups and in considering the role of incidental surgery.

Management of acquired rectourinary fistulas: how often and when is permanent fecal or urinary diversion necessary?

PURPOSE: The objective of this study was to evaluate our experience in the management of acquired rectourinary fistulas at our tertiary center. METHODS: Eighteen patients with fistulas treated from 1999 to 2004 were retrospectively reviewed for demographics, etiology of the fistulas, treatment, and outcome. RESULTS: The median age of the group was 69 years. Sixteen patients had fistulas that were malignant-associated. One patient died from tumor progression before any surgical therapy. The remaining 17 patients underwent surgical treatment of the fistula with a median of one procedure per patient. Eight patients had excision with permanent diversion, two had excision with repair/reconstructive procedures, and seven had repair surgical procedures. Initial surgical management was successful for 13 (76 percent) patients. Reoperation resulted in a final success rate of 100 percent. The rates of permanent fecal, urinary, and fecal plus urinary diversion in the malignant associated fistula group were 5.8, 47, and 5.8 percent, respectively. The median follow-up for all patients was 9.5 months. There were no procedure-related mortalities and five (29 percent) patients had significant surgical-related morbidity. CONCLUSIONS: Our data suggest that surgical treatment for acquired rectourinary fistulas can successfully avoid permanent fecal and/or urinary diversion in a large number of patients if locally curative cancer treatment can be achieved.

Morbidity of ostomy takedown.

PURPOSE: Creation of a temporary ostomy is a surgical tool to divert stool from a more distal area of concern (anastomosis, inflammation, etc). To provide a true benefit, the morbidity/mortality from the ostomy takedown itself should be minimal. The aim of our study was therefore to evaluate our own experience and determine the complications and mortality of stoma closure in relation to the type and location of the respective ostomy. METHODS: Patients undergoing an elective takedown of a temporary ostomy at our teaching institution between January 1999 and July 2005 were included in our analysis, and the medical records were retrospectively reviewed. Excluded were only patients with relevant chart deficiencies and nonelective stoma revisions/takedowns. Data collected included general demographics; the type and location of the stoma; the operative technique; and the type, timing, and impact of complications. Perioperative morbidity was defined as complications occurring within 30 days from the operation. RESULTS: 156 patients (median age 45 years, range 18-85) were included in the analysis: 31 loop and 59 end colostomy reversals and 56 loop and 10 end ileostomy takedowns. Mean follow-up was 6 months. The overall mortality rate was low (0.65%, 1/156 patients). However, the morbidity rate was 36.5% (57 patients), with 6 (3.8%) systemic complications and 51 (32.7%) local complications. Minor would infection (34 patients, 21.8%) and postoperative ileus (9 patients, 5.7%) were the most common surgery-related complications, but they generally resolved with conservative management. Anastomotic leak and formation/persistence of an enterocutaneous fistula (6 patients, 3.8%) were the most serious local complications and required reintervention in all of the patients. Closure of a loop colostomy accounted for half and Hartmann reversals for one third of these complications, as opposed to ileostomy takedowns, which accounted for only one sixth (1.8% absolute risk). CONCLUSION: Takedown of a temporary ostomy has a low mortality but a nonnegligible morbidity. The stoma location (large vs. small bowel) has a higher impact than the type of stoma construction (end vs. loop) on the incidence and severity of complications.

Multidisciplinary management of patients with advanced rectal cancer.

The chance of lymph node involvement in T(3) and T(4) rectal cancers is 20% to 60%, a risk sufficiently high that most clinicians favor mesorectal excision rather than less aggressive approaches. Patients who have a complete clinical response of the primary lesions to neoadjuvant therapy may represent a special case. Total mesorectal excision can be accomplished without sacrifice of the anal sphincters, and continence can be preserved. Evolving understanding of patterns of tumor spread and mechanisms of anal continence have resulted in increased use of continence-preserving procedures. Removal of the anal sphincters seems to be advantageous only if the sphincters are directly involved. A few small series suggest that a segmental sphincter resection could result in good local control and continence preservation, even if the sphincters are involved. Areas of controversy currently include the role of neoadjuvant therapy for high rectal lesions, the role of lateral lymph node dissection, and methods of improving anal continence after rectal resection.

New approaches to assessing and treating early-stage colon and rectal cancer: summary statement from 2007 Santa Monica Conference.

The 2007 Santa Monica Conference on Assessing and Treating Early-Stage Colon and Rectal Cancer, a multidisciplinary meeting of leaders in surgery, medical and radiation oncology, and pathology, was convened on January 12 to 13, 2007. The purpose of the meeting was to assess current data and issues in the field and to develop recommendations for advancing patient care and clinical research. Topics included pathologic assessment and staging, transanal versus laparoscopic versus open resection, adjuvant therapy, genetic testing and counseling, cooperative group strategies, and the use of biological therapies and novel agents. A review of the key issues discussed, as well as conclusions and recommendations considered significant to the field, is summarized below and presented at greater length in the individual manuscripts and accompanying discussion that comprise the full conference proceedings. Although the management of early-stage colon and rectal cancers remains a challenge for all of us, the development and use of new technologies and methods of assessment and treatment over the past several decades is yielding encouraging results. A variety of opportunities to further improve outcomes were addressed in this forum, including recommendations that specific protocols be adopted regarding surgical and pathologic dissection and reporting, particularly for stage II disease; the corollary need to increase active multidisciplinary collaboration; and the development of comprehensive consensus guidelines and recommendations to standardize care in early-stage colorectal cancer.

A comparison of laparoscopically assisted and open colectomy for colon cancer.

BACKGROUND: Minimally invasive, laparoscopically assisted surgery was first considered in 1990 for patients undergoing colectomy for cancer. Concern that this approach would compromise survival by failing to achieve a proper oncologic resection or adequate staging or by altering patterns of recurrence (based on frequent reports of tumor recurrences within surgical wounds) prompted a controlled trial evaluation. METHODS: We conducted a noninferiority trial at 48 institutions and randomly assigned 872 patients with adenocarcinoma of the colon to undergo open or laparoscopically assisted colectomy performed by credentialed surgeons. The median follow-up was 4.4 years. The primary end point was the time to tumor recurrence. RESULTS: At three years, the rates of recurrence were similar in the two groups--16 percent among patients in the group that underwent laparoscopically assisted surgery and 18 percent among patients in the open-colectomy group (two-sided P=0.32; hazard ratio for recurrence, 0.86; 95 percent confidence interval, 0.63 to 1.17). Recurrence rates in surgical wounds were less than 1 percent in both groups (P=0.50). The overall survival rate at three years was also very similar in the two groups (86 percent in the laparoscopic-surgery group and 85 percent in the open-colectomy group; P=0.51; hazard ratio for death in the laparoscopic-surgery group, 0.91; 95 percent confidence interval, 0.68 to 1.21), with no significant difference between groups in the time to recurrence or overall survival for patients with any stage of cancer. Perioperative recovery was faster in the laparoscopic-surgery group than in the open-colectomy group, as reflected by a shorter median hospital stay (five days vs. six days, P<0.001) and briefer use of parenteral narcotics (three days vs. four days, P<0.001) and oral analgesics (one day vs. two days, P=0.02). The rates of intraoperative complications, 30-day postoperative mortality, complications at discharge and 60 days, hospital readmission, and reoperation were very similar between groups. CONCLUSIONS: In this multi-institutional study, the rates of recurrent cancer were similar after laparoscopically assisted colectomy and open colectomy, suggesting that the laparoscopic approach is an acceptable alternative to open surgery for colon cancer.

Care after colonic operation--is it evidence-based? Results from a multinational survey in Europe and the United States.

BACKGROUND: Despite clinical evidence showing that steps can be taken perioperatively to enhance postoperative recovery and decrease morbidity in colonic operation patients, there is no comprehensive information on how widespread such practices are, or the combination of such steps into effective multimodal rehabilitation (fast-track) colonic surgery programs to decrease hospital stay. This survey investigated clinical practice around colonic operations across Europe and the United States. METHODS: The survey was conducted in 295 hospitals in the United Kingdom, France, Germany, Italy, Spain, and the United States. Details of perioperative care and postoperative recovery were recorded for 1,082 patients who had undergone elective colonic operations and who were discharged (or died) over a 2-week period (United States: up to 4 weeks). RESULTS: Preoperative bowel clearance was used in >85% of patients. A nasogastric tube was left in situ postoperatively in 40% versus 66% of patients in the United States and Europe, respectively, and was removed about 3 days postoperatively. It took 3 to 4 days until 50% of the patients first tolerated liquids and 4 to 5 days until 50% of patients were eating and having a bowel movement. Postoperative ileus was found to persist for over 5 days in approximately 45% of patients. Mean length of postoperative hospital stay was over 10 days in the United Kingdom, France, Germany, Italy, and Spain, and 7 days in the United States, compared with 2 to 5 days reported in trials of fast-track colonic surgery programs. CONCLUSIONS: Strategies that can contribute to improved recovery and reduced complications after colonic operations do not appear to be applied optimally in clinical practice across Europe and the United States. These findings indicate a potential for major improvements in outcomes and reduction of costs if peri- and postoperative care can be adjusted to be in line with published evidence.