Surgical quality surrogates do not predict colon cancer survival in the setting of technical credentialing: a report from the prospective COST trial.

OBJECTIVE: We tested the hypothesis that the 12 lymph node (LN) count and other surgical variables would not predict survival in a setting where surgical techniques were standardized and surgeons were credentialed and audited. BACKGROUND: The National Quality Forum has adopted the 12-node minimum as a surgical quality metric due to the strong association between node count and survival. METHODS: We performed a secondary analysis of data from the Clinical Outcomes of Surgical Therapy (COST) multicenter randomized trial testing laparoscopic versus open colectomy. Surgeons were credentialed and video-audited for adherence to technical standards. Patients with noninvasive and stage IV disease were excluded, leaving 787 subjects (267 stage I, 284 stage II, and 236 stage III). Median age was 70 years and 50% were male. The overall 5-year survival was 77.2%. RESULTS: Five-year overall and disease-free survival was not influenced by LN count (< 12 vs ≥ 12), sex, tumor location (right vs left vs sigmoid), surgical technique (laparoscopic vs open), total bowel length, proximal margin, distal margin, radial margin, or mesenteric length (P > 0.05 for all). Univariate predictors of survival included age and cancer stage, and these remained significant in the multivariate model. Across all stages of disease, after adjusting for age and stage, LN count did not predict overall or disease-free survival (P = 0.60). CONCLUSIONS: Despite the known association between LN count and survival, we could not confirm an association between surgical surrogates and cancer outcomes. We postulate that standardization, credentialing, and monitoring may be more important than traditional surgical quality surrogates.

Adoption of laparoscopic colectomy: results and implications of ASCRS hands-on course participation.

INTRODUCTION: Beginning in 2003, the American Society of Colon and Rectal Surgeons has annually sponsored a laparoscopic colon and rectal surgery instructional course using a cadaver model. This study reports the adoption rate and postcourse practice patterns of participants. METHODS: All prior participants of hands-on courses from 2003 to 2005 were asked to participate in a 25-question survey. Questions probed practice setting, prior laparoscopic experience, motivation for course participation, time to, indication for, and type of first laparoscopic colectomy, experience prior to cancer resection, factors facilitating skill acquisition, and impact on practice from course completion. RESULTS: A total of 43 of 63 participants completed the survey and 53% had performed at least 1 laparoscopic colon resection prior to the course. A laparoscopic colon resection was performed within 1 week of the course by 52% of participants and within 1 month by 90%. Laparoscopic colectomy was performed frequently postcourse with 42% performing between 1 and 5 laparoscopic colectomies/month and 42% between 5 and 10. Hand-assisted technologies lowered the threshold for performance of first laparoscopic colectomy for 62% of participants. Cancer resection was the first procedure for 31% and 36% performed between 5 and 10 colectomies prior to cancer resection. Most important factor in particular course selection was a cadaver model (77%). A majority of the participants would require course completion prior to granting hospital privileges (73%) and would recommend the course to other surgeons (97%). CONCLUSIONS: Cadaver course completion enables rapid integration of laparoscopic colon resection into clinical practice. Experience prior to laparoscopic resection of cancer is modest. Hand-assisted technologies promote technique acquisition.

Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society.

Adenomatous polyps are the most common neoplastic findings uncovered in people who undergo colorectal screening or have a diagnostic workup for symptoms. It was common practice in the 1970s for these patients to have annual follow-up surveillance examinations to detect additional new adenomas as well as missed synchronous adenomas. As a result of the National Polyp Study report in 1993, which demonstrated clearly in a randomized design that the first postpolypectomy examination could be deferred for 3 years, guidelines published by a gastrointestinal consortium in 1997 recommended that the first follow-up surveillance be 3 years after polypectomy for most patients. In 2003, these guidelines were updated, colonoscopy was recommended as the only follow-up examination, and stratification at baseline into lower and higher risk for subsequent adenomas was suggested. The 1997 and 2003 guidelines dealt with both screening and surveillance. However, it has become increasingly clear that postpolypectomy surveillance is now a large part of endoscopic practice, draining resources from screening and diagnosis. In addition, surveys have demonstrated that a large proportion of endoscopists are conducting surveillance examinations at shorter intervals than recommended in the guidelines. In the present paper, a careful analytic approach was designed addressing all evidence available in the literature to delineate predictors of advanced pathology, both cancer and advanced adenomas, so that patients can be more definitely stratified at their baseline colonoscopy into those at lower or increased risk for a subsequent advanced neoplasia. People at increased risk have either three or more adenomas, or high-grade dysplasia, or villous features, or an adenoma > or =1 cm in size. It is recommended that they have a 3-year follow-up colonoscopy. People at lower risk who have one or two small (< 1 cm) tubular adenomas with no high-grade dysplasia can have a follow-up in 5 to 10 years, whereas people with hyperplastic polyps only should have a 10-year follow-up as average-risk people. Recent papers have reported a significant number of missed cancers by colonoscopy. However, high-quality baseline colonoscopy with excellent patient preparation and adequate withdrawal time should minimize this and reduce clinicians' concerns. These guidelines were developed jointly by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society to provide a broader consensus and thereby increase utilization of the recommendations by endoscopists. Adoption of these guidelines nationally can have a dramatic impact on shifting available resources from intensive surveillance to screening. It has been shown that the first screening colonoscopy and polypectomy produces the greatest effects on reducing the incidence of colorectal cancer in patients with adenomatous polyps.

Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and US Multi-Society Task Force on Colorectal Cancer.

Patients with resected colorectal cancer are at risk for recurrent cancer and metachronous neoplasms in the colon. This joint update of guidelines by the American Cancer Society (ACS) and US Multi-Society Task Force on Colorectal Cancer addresses only the use of endoscopy in the surveillance of these patients. Patients with endoscopically resected Stage I colorectal cancer, surgically resected Stage II and III cancers, and Stage IV cancer resected for cure (isolated hepatic or pulmonary metastasis) are candidates for endoscopic surveillance. The colorectum should be carefully cleared of synchronous neoplasia in the perioperative period. In nonobstructed colons, colonoscopy should be performed preoperatively. In obstructed colons, double contrast barium enema or computed tomography colonography should be done preoperatively, and colonoscopy should be performed 3 to 6 months after surgery. These steps complete the process of clearing synchronous disease. After clearing for synchronous disease, another colonoscopy should be performed in 1 year to look for metachronous lesions. This recommendation is based on reports of a high incidence of apparently metachronous second cancers in the first 2 years after resection. If the examination at 1 year is normal, then the interval before the next subsequent examination should be 3 years. If that colonoscopy is normal, then the interval before the next subsequent examination should be 5 years. Shorter intervals may be indicated by associated adenoma findings (see Postpolypectomy Surveillance Guideline). Shorter intervals are also indicated if the patient's age, family history, or tumor testing indicate definite or probable hereditary nonpolyposis colorectal cancer. Patients undergoing low anterior resection of rectal cancer generally have higher rates of local cancer recurrence, compared with those with colon cancer. Although effectiveness is not proven, performance of endoscopic ultrasound or flexible sigmoidoscopy at 3- to 6-month intervals for the first 2 years after resection can be considered for the purpose of detecting a surgically curable recurrence of the original rectal cancer.

Guidelines for colonoscopy surveillance after cancer resection: a consensus update by the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer.

Patients with resected colorectal cancer are at risk for recurrent cancer and metachronous neoplasms in the colon. This joint update of guidelines by the American Cancer Society and the US Multi-Society Task Force on Colorectal Cancer addresses only the use of endoscopy in the surveillance of these patients. Patients with endoscopically resected Stage I colorectal cancer, surgically resected Stages II and III cancers, and Stage IV cancer resected for cure (isolated hepatic or pulmonary metastasis) are candidates for endoscopic surveillance. The colorectum should be carefully cleared of synchronous neoplasia in the perioperative period. In nonobstructed colons, colonoscopy should be performed preoperatively. In obstructed colons, double-contrast barium enema or computed tomography colonography should be performed preoperatively, and colonoscopy should be performed 3 to 6 months after surgery. These steps complete the process of clearing synchronous disease. After clearing for synchronous disease, another colonoscopy should be performed in 1 year to look for metachronous lesions. This recommendation is based on reports of a high incidence of apparently metachronous second cancers in the first 2 years after resection. If the examination at 1 year is normal, then the interval before the next subsequent examination should be 3 years. If that examination is normal, then the interval before the next subsequent examination should be 5 years. Shorter intervals may be indicated by associated adenoma findings (see "Guidelines for Colonoscopy Surveillance After Polypectomy: A Consensus Update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society"). Shorter intervals also are indicated if the patient's age, family history, or tumor testing indicate definite or probable hereditary nonpolyposis colorectal cancer. Patients undergoing low anterior resection of rectal cancer generally have higher rates of local cancer recurrence compared with those with colon cancer. Although effectiveness is not proven, performance of endoscopic ultrasound or flexible sigmoidoscopy at 3- to 6-month intervals for the first 2 years after resection can be considered for the purpose of detecting a surgically curable recurrence of the original rectal cancer.

Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society.

Adenomatous polyps are the most common neoplastic findings discovered in people who undergo colorectal screening or who have a diagnostic work-up for symptoms. It was common practice in the 1970s for these patients to have annual follow-up surveillance examinations to detect additional new adenomas and missed synchronous adenomas. As a result of the National Polyp Study report in 1993, which showed clearly in a randomized design that the first postpolypectomy examination could be deferred for 3 years, guidelines published by a gastrointestinal consortium in 1997 recommended that the first follow-up surveillance take place 3 years after polypectomy for most patients. In 2003 these guidelines were updated and colonoscopy was recommended as the only follow-up examination, stratification at baseline into low risk and higher risk for subsequent adenomas was suggested. The 1997 and 2003 guidelines dealt with both screening and surveillance. However, it has become increasingly clear that postpolypectomy surveillance is now a large part of endoscopic practice, draining resources from screening and diagnosis. In addition, surveys have shown that a large proportion of endoscopists are conducting surveillance examinations at shorter intervals than recommended in the guidelines. In the present report, a careful analytic approach was designed to address all evidence available in the literature to delineate predictors of advanced pathology, both cancer and advanced adenomas, so that patients can be stratified more definitely at their baseline colonoscopy into those at lower risk or increased risk for a subsequent advanced neoplasia. People at increased risk have either 3 or more adenomas, high-grade dysplasia, villous features, or an adenoma 1 cm or larger in size. It is recommended that they have a 3-year follow-up colonoscopy. People at lower risk who have 1 or 2 small (<1 cm) tubular adenomas with no high-grade dysplasia can have a follow-up evaluation in 5-10 years, whereas people with hyperplastic polyps only should have a 10-year follow-up evaluation, as for average-risk people. There have been recent studies that have reported a significant number of missed cancers by colonoscopy. However, high-quality baseline colonoscopy with excellent patient preparation and adequate withdrawal time should minimize this and reduce clinicians concerns. These guidelines were developed jointly by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society to provide a broader consensus and thereby increase the use of the recommendations by endoscopists. The adoption of these guidelines nationally can have a dramatic impact on shifting available resources from intensive surveillance to screening. It has been shown that the first screening colonoscopy and polypectomy produces the greatest effects on reducing the incidence of colorectal cancer in patients with adenomatous polyps.

Reoperation following minimally invasive surgery: are the "rules" different?

This article discusses various indications for reoperation and how employing laparoscopy at primary operation might affect the incidence, presentation, and treatment of common complications. The abdomen is likely to be far less hostile after laparoscopic surgery than after laparotomy. Adhesions to the anterior abdominal wall are minimal or absent. As a result, relaparoscopy is a reasonable diagnostic and often successful treatment modality in patients suspected of having intra-abdominal complications following laparoscopic operation. Laparoscopic success in dealing with acute bowel obstruction after laparoscopic surgery is related to the paucity of adhesions and unique mechanisms of obstruction that are localized and amenable to minimal dissection. The same mechanisms are also responsible for the increased risk of bowel necrosis associated with bowel obstruction after laparoscopic surgery. Limited experience with successful laparoscopic management of bleeding and anastomotic leak has been reported with the caveat that if the bleeding or contamination is excessive, cannot be identified and controlled quickly, or is unresponsive to a reasonable and brief effort using laparoscopy, a prompt laparotomy is indicated. Based on the current literature, it is reasonable to conclude that laparoscopic approaches to primary Crohn's disease and relaparoscopy for recurrence are an appropriate (perhaps the most appropriate) management strategy. Also, laparoscopic restorative proctocolectomy and ileal pouch-anal anastomosis after laparoscopic subtotal colectomy is the preferred treatment for toxic ulcerative colitis. We conclude that laparoscopic reoperative surgery is feasible for the treatment of many complications following laparoscopic major abdominal surgery and bowel resection.

Screening methods for high-grade dysplasia in patients with anal condyloma.

UNLABELLED: Human papilloma virus (HPV) is one of the most common sexually transmitted diseases in the United States. HPV infection can cause anal condylomas and is a risk factor for dysplasia. High-grade dysplasia may progress to squamous cell carcinoma. Currently, biopsy and histological examination are required to grade dysplasia. The purpose of this study is to determine whether anal cytology, morphological characteristics, and/or the presence of high-risk oncogenic HPV-types are effective noninvasive methods to detect high-risk anal condylomas. PATIENTS AND METHODS: From November 2003 to June 2004, all patients with anal condyloma were prospectively evaluated for anal cytology, high-risk oncogenic HPV-types, and tissue biopsies. The Bethesda classification system was used to classify cytologic findings and histological examination, which were grouped as high-risk (HRL) and low-risk (LRL) lesions. Histology results served as true disease for all comparisons. RESULTS: Forty-seven patients with anal condyloma were studied; 43 (91.5%) were men, and the mean age was 39 +/- 11 years. Histology showed 19 (40.5%) patients with HRL, and 28 (59.5%) patients with LRL. Cytology correctly identified 8 patients with HRL and 27 patients with LRL (sensitivity 42% and specificity 96%). High-risk oncogenic HPV-types were found in 84.2% of HRL and 39.3% of LRL (P = 0.0029). Combining cytology with oncogenic HPV-testing, the sensitivity of detecting HRL increased to 89%, and specificity decreased to 42%. CONCLUSION: Anal cytology alone is not accurate for detecting HRL in patients with anal condylomas. Combining oncogenic HPV-testing with cytology is more sensitive in detecting HRL in patients with anal condyloma, and therefore, a more effective screening tool.

Practice parameters for the management of rectal cancer (revised).

The American Society of Colon and Rectal Surgeons is dedicated to assuring high-quality patient care by advancing the science, prevention, and management of disorders and diseases of the colon, rectum, and anus. The Standards Committee is composed of Society members who are chosen because they have demonstrated expertise in the specialty of colon and rectal surgery. This Committee was created to lead international efforts in defining quality care for conditions related to the colon, rectum, and anus. This is accompanied by developing Clinical Practice Guidelines based on the best available evidence. These guidelines are inclusive, and not prescriptive. Their purpose is to provide information on which decisions can be made, rather than dictate a specific form of treatment. These guidelines are intended for the use of all practitioners, health care workers, and patients who desire information about the management of the conditions addressed by the topics covered in these guidelines. It should be recognized that these guidelines should not be deemed inclusive of all proper methods of care or exclusive of methods of care reasonably directed to obtaining the same results. The ultimate judgment regarding the propriety of any specific procedure must be made by the physician in light of all of the circumstances presented by the individual patient.

Outcome of HIV-infected patients with invasive squamous-cell carcinoma of the anal canal in the era of highly active antiretroviral therapy.

PURPOSE: Before the development of highly active antiretroviral therapy for the treatment of HIV infection, HIV patients diagnosed with invasive squamous-cell carcinoma of the anal canal carried a very poor prognosis. This study was designed to determine the outcome in a similar group of patients in the era of highly active antiretroviral therapy. METHODS: HIV-positive patients treated for invasive squamous-cell carcinoma of the anal canal at the University of Texas Medical Center affiliated hospitals from 1980 to 2001 were identified from operative data and cancer registries. We reviewed these records and collected data regarding age, CD4 count, highly active antiretroviral therapy, cancer treatment, complications, and survival. The patients were divided into two groups based on the presence or absence of highly active antiretroviral therapy and compared using a Kaplan-Meier approach. RESULTS: Fourteen patients with HIV and invasive squamous-cell carcinoma of the anal canal were identified. Six were in the prehighly active antiretroviral therapy group and eight in the highly active antiretroviral therapy group. All were considered for treatment with chemotherapy and radiation. In the prehighly active antiretroviral therapy group, one patient refused therapy and three were unable to complete the squamous-cell carcinoma therapy as planned because of complications. Four of eight highly active antiretroviral therapy patients were unable to complete the squamous-cell carcinoma therapy as planned. The prehighly active antiretroviral therapy patients had a mean age of 40 years and a mean CD4 count of 190 at the time of diagnosis. The highly active antiretroviral therapy patients had a mean age of 44 years and a mean CD4 count of 255 at the time of diagnosis. The 24-month survival was 17 percent in the prehighly active antiretroviral therapy group and 67 percent in the highly active antiretroviral therapy group (P = 0.0524). All six patients in the prehighly active antiretroviral therapy group died with active squamous-cell carcinoma vs. two in the highly active antiretroviral therapy group. Four of the remaining six patients had no evidence of active squamous-cell carcinoma at the last follow-up visit. CONCLUSIONS: A review of patients with HIV and invasive squamous-cell carcinoma of the anal canal suggests a trend toward a higher CD4 count at the time of diagnosis and improved survival in patients receiving highly active antiretroviral therapy. In this new era, HIV-positive patients should be on highly active antiretroviral therapy. If not, highly active antiretroviral therapy should be initiated, and standard multimodality therapies for invasive squamous-cell carcinoma of the anal canal are recommended.

Identification and validation of genes involved in the pathogenesis of colorectal cancer using cDNA microarrays and RNA interference.

PURPOSE: The purpose of this study was to profile gene expression changes in colorectal tumors to identify new targets and strategies for the management of this disease. EXPERIMENTAL DESIGN: cDNA microarray analysis was used to detect differences in gene expression between normal tissue and colon tumors and polyps isolated from 20 patients. To identify genes that are important in regulating the growth properties of colorectal cancer, RNA interference (RNAi) was used to disrupt expression of several of the overexpressed genes in a colon tumor cell line, HCT116, which showed similar patterns of gene expression as many of the patient tumors. RESULTS: Expression changes of > or =2-fold in approximately one-third of the patients were consistently observed for 2632 of a total of 9592 genes (574 up-regulated genes and 2058 down-regulated genes). Subsequent analysis of 13 genes by quantitative real-time PCR confirmed the reliability of this analysis. RNAi-mediated disruption of the expression of one of these genes, survivin, a potent inhibitor of apoptosis, severely reduced tumor growth both in vitro and in an in vivo xenograft model. CONCLUSIONS: The combined use of microarray analysis and RNAi provides an excellent system to define the role of specific genes that are up-regulated in cancer lead to the increased in vitro and in vivo growth of colon tumors.

Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence.

We have updated guidelines for screening for colorectal cancer. The original guidelines were prepared by a panel convened by the U.S. Agency for Health Care Policy and Research and published in 1997 under the sponsorship of a consortium of gastroenterology societies. Since then, much has changed, both in the research rature and in the clinical context. The present report summarizes new developments in this field and suggests how they should change practice. As with the previous version, these guidelines offer screening options and encourage the physician and patient to decide together which is the best approach for them. The guidelines also take into account not only the effectiveness of screening but also the risks, inconvenience, and cost of the various approaches. These guidelines differ from those published in 1997 in several ways: we recommend against rehydrating fecal occult blood tests; the screening interval for double contrast barium enema has been shortened to 5 years; colonoscopy is the preferred test for the diagnostic investigation of patients with findings on screening and for screening patients with a family history of hereditary nonpolyposis colorectal cancer; recommendations for people with a family history of colorectal cancer make greater use of risk stratification; and guidelines for genetic testing are included. Guidelines for surveillance are also included. Follow-up of postpolypectomy patients relies now on colonoscopy, and the first follow-up examination has been lengthened from 3 to 5 years for low-risk patients. If this were adopted nationally, surveillance resources could be shifted to screening and diagnosis. Promising new screening tests (virtual colonoscopy and tests for altered DNA in stool) are in development but are not yet ready for use outside of research studies. Despite a consensus among expert groups on the effectiveness of screening for colorectal cancer, screening rates remain low. Improvement depends on changes in patients' attitudes, physicians' behaviors, insurance coverage, and the surveillance and reminder systems necessary to support screening programs.

Emergency surgery for colon carcinoma.

PURPOSE: Emergency surgery for colon cancer is widely thought to be associated with increased likelihood of surgical morbidity and mortality; however, other coexistent factors such as advanced disease, the age of the patient, and medical comorbid conditions may also influence these outcomes. The primary purpose of this study was to identify the relative risk for surgical morbidity and/or mortality conferred by emergency surgery compared with elective surgery for patients with colon cancer. METHODS: An Institutional Review Board-approved, case-control study was performed. During the period from January 1, 1995, to June 30, 2001, a total of 184 primary surgeries for colon cancer were performed. Emergency indications for surgery were defined as peritonitis, intra-abdominal abscess, or complete bowel obstruction at presentation (defined as emesis, distention on examination, and confirmatory plain radiograph films). By this definition, 29 patients (15.7 percent) met the criteria for inclusion. These patients were age and stage matched with 29 patients derived from the remaining 155 patients. Information was collected on surgical morbidity and mortality, length of stay, and survival. RESULTS: Age, medical comorbidities, and stage of disease were well matched between groups. The indications for the 29 emergency surgeries were as follows: 6 for peritonitis, 2 for abscesses, and 21 for complete obstructions. Nine patients did not have their primary tumor removed. Sixteen patients underwent resection and anastomosis; the remaining four patients underwent a Hartmann's procedure. Overall surgical morbidity (64 vs. 24 percent; odds ratio, 5.1; 95 percent confidence interval, 1.7-16) and mortality (34 vs. 7 percent; odds ratio, 7.1; 95 percent confidence interval, 1.4-36.2) were significantly higher for patients undergoing emergency surgery. Among patients surviving surgery, there was no difference in overall survival between patients undergoing emergency compared with elective operation. CONCLUSIONS: Emergency surgery has a strong negative influence (beyond that which is expected based on stage of disease) on immediate surgical morbidity and mortality. The similarity between the two groups in overall survival for patients surviving the perioperative period suggests that the negative impact of emergency surgery is confined to the immediate postoperative period.

Diverticular disease.

Diverticular disease is a common finding in Western countries with an increasing prevalence with age. Many patients with the disorder remain asymptomatic. However, up to 30% of those affected may show clinical signs including pain, bleeding, obstruction, abscess, fistulae and perforation. The purpose of this chapter is to review the epidemiology, pathogenesis, clinical presentation, diagnostic regimens and treatment options for this disorder.