Cost Effectiveness of Watch and Wait Versus Resection in Rectal Cancer Patients with Complete Clinical Response to Neoadjuvant Chemoradiation.

BACKGROUND: Watch and wait (WW) protocols have gained increasing popularity for patients diagnosed with locally advanced rectal cancer and presumed complete clinical response after neoadjuvant chemoradiation. While studies have demonstrated comparable survival and recurrence rates between WW and radical surgery, the decision to undergo surgery has significant effects on patient quality of life. We sought to conduct a cost-effectiveness analysis comparing WW with abdominoperineal resection (APR) and low anterior resection (LAR) among patients with stage II/III rectal cancer. METHODS: In this comparative-effectiveness study, we built Markov microsimulation models to simulate disease progression, death, costs, and quality-adjusted life-years (QALYs) for WW or APR/LAR. We assessed cost effectiveness using the incremental cost-effectiveness ratio (ICER), with ICERs under $100,000/QALY considered cost effective. Probabilities of disease progression, death, and health utilities were extracted from published, peer-reviewed literature. We assessed costs from the payer perspective. RESULTS: WW dominated both LAR and APR at a willingness to pay (WTP) threshold of $100,000. Our model was most sensitive to rates of distant recurrence and regrowth after WW. Probabilistic sensitivity analysis demonstrated that WW was the dominant strategy over both APR and LAR over 100% of iterations across a range of WTP thresholds from $0-250,000. CONCLUSIONS: Our study suggests WW could reduce overall costs and increase effectiveness compared with either LAR or APR. Additional clinical research is needed to confirm the clinical efficacy and cost effectiveness of WW compared with surgery in rectal cancer.

Rapid tumor-labeling kinetics with a site-specific near-infrared anti-CEA nanobody in a patient-derived orthotopic xenograft mouse model of colon cancer.

BACKGROUND/OBJECTIVES: Nanobodies are the smallest biologic antigen-binding fragments derived from camelid-derived antibodies. Nanobodies effect a peak tumor signal within minutes of injection and present a novel opportunity for fluorescence-guided surgery (FGS). The present study demonstrates the efficacy of an anti-CEA nanobody conjugated to near-infrared fluorophore LICOR-IRDye800CW for rapid intraoperative tumor labeling of colon cancer. METHODS: LS174T human colon cancer cells or fragments of patient-derived colon cancer were implanted subcutaneously or orthotopically in nude mice. Anti-CEA nanobodies were conjugated with IRDye800CW and 1-3 nmol were injected intravenously. Mice were serially imaged over time. Peak fluorescence signal and tumor-to-background ratio (TBR) were recorded. RESULTS: Colon cancer tumors were detectable using fluorescent anti-CEA nanobody within 5 min of injection at all three doses. Maximal fluorescence intensity was observed within 15 min-3 h for all three doses with TBR values ranging from 1.3 to 2.3. In the patient-derived model of colon cancer, fluorescence was detectable with a TBR of 4.6 at 3 h. CONCLUSIONS: Fluorescent anti-CEA nanobodies rapidly and specifically labeled colon cancer in cell-line-based and patient-derived orthotopic xenograft (PDOX) models. The kinetics of nanobodies allow for same day administration and imaging. Anti-CEA-nb-800 is a promising and practical molecule for FGS of colon cancer.

3D-Printed Ostomy Flange Stabilizer.

BACKGROUND: One of the coauthors with tetraplegia (quadriplegia) and a colostomy invented an ostomy flange stabilizer to act as a temporary backplate and aid in pouch changes. DEVICE DEVELOPMENT: In an interactive design process, a 3D-printed ostomy flange stabilizer device was created. The resulting device can be adapted to 3 standard stoma appliance sizes. The stabilizer is reversible, allowing right- and left-handed people to use it on right- or left-sided stomas. Anyone with a 3D printer can print this device from an open-access Web site. CONCLUSION: This device may be of use to many with ostomies and especially those with impaired dexterity.A 3D-printed ostomy flange stabilizer is described. 3D printing allows patient inventions to be disseminated without commercialization.

General surgery training in the era of robotic surgery: a qualitative analysis of perceptions from resident and attending surgeons.

BACKGROUND: The use of the surgical robot has increased annually since its introduction, especially in general surgery. Despite the tremendous increase in utilization, there are currently no validated curricula to train residents in robotic surgery, and the effects of robotic surgery on general surgery residency training are not well defined. In this study, we aim to explore the perceptions of resident and attending surgeons toward robotic surgery education in general surgery residency training. METHODS: We performed a qualitative thematic analysis of in-person, one-on-one, semi-structured interviews with general surgery residents and attending surgeons at a large academic health system. Convenient and purposeful sampling was performed in order to ensure diverse demographics, experiences, and opinions were represented. Data were analyzed continuously, and interviews were conducted until thematic saturation was reached, which occurred after 20 residents and seven attendings. RESULTS: All interviewees agreed that dual consoles are necessary to maximize the teaching potential of the robotic platform, and the importance of simulation and simulators in robotic surgery education is paramount. However, further work to ensure proper access to simulation resources for residents is necessary. While most recognize that bedside-assist skills are essential, most think its educational value plateaus quickly. Lastly, residents believe that earlier exposure to robotic surgery is necessary and that almost every case has a portion that is level-appropriate for residents to perform on the robot. CONCLUSIONS: As robotic surgery transitions from novelty to ubiquity, the importance of effective general surgery robotic surgery training during residency is paramount. Through in-depth interviews, this study provides examples of effective educational tools and techniques, highlights the importance of simulation, and explores opinions regarding the role of the resident in robotic surgery education. We hope the insights gained from this study can be used to develop and/or refine robotic surgery curricula.

Piles of Money: "Hemorrhoids" Are a Billion-Dollar Industry.

Two persistent problems confront anyone wishing to gauge the public-health cost and impact of hemorrhoids. First, there is the slipperiness of the term "hemorrhoids," which both patients and physicians use with imprecision. Second, there is endoscopic over-diagnosis of prominent anal cushions as internal hemorrhoids. While these factors both inflate the apparent cost of hemorrhoids, the fact remains that hemorrhoid diagnosis and treatment has become a billion-dollar industry.

Expectant Management of High-Grade Anal Dysplasia in People with HIV: Long-term Data.

BACKGROUND: Both ablation and expectant management of high-grade squamous intraepithelial lesions have been proposed. Expectant management would be reasonable if 1) the rate of high-grade squamous epithelial lesion progression to anal squamous cell carcinoma were low, and 2) anal squamous cell carcinoma arising under surveillance had a better prognosis than anal squamous cell carcinoma presenting without an identified precursor. OBJECTIVE: This study aims to quantify aspects of high-grade squamous epithelial lesion/anal squamous cell carcinoma clinical evolution in a surgical practice. DESIGN: This is a retrospective cohort study. SETTINGS: This study was performed in 1 colorectal surgeon's practice over a 20-year period. PATIENTS: Consecutive patients with high-grade squamous intraepithelial lesion and anal squamous cell carcinoma were included. MAIN OUTCOME MEASURES: We looked at the rate and timing of progression to anal squamous cell carcinoma, and the stage, treatment, and outcome of anal squamous cell carcinoma. We reviewed a comparison group of HIV-positive patients presenting de novo with anal squamous cell carcinoma (no prior history of high-grade squamous intraepithelial lesion). RESULTS: With consideration of only HIV-positive patients, 341 patients had a mean 5.6 years follow-up from high-grade squamous intraepithelial lesion diagnosis to the most recent documented anal examination. Twenty-four of these surveillance patients developed anal squamous cell carcinoma, yielding a progression rate of 1.3% per patient-year. Mean follow-up was 7.3 years from the initial cancer diagnosis to the most recent contact. Forty-seven patients who presented de novo with anal squamous cell carcinoma developed 74 lesions, with a mean follow-up of 5.7 years after initial diagnosis. This de novo group had higher anal squamous cell carcinoma-specific mortality (3% per patient-year vs 0.05%). Our study did not show a significantly higher rate of high stage (stage III or IV) at anal squamous cell carcinoma diagnosis in the de novo group in comparison with the surveillance group (25.5% vs 8.3% (p = 0.09)). LIMITATIONS: This study was retrospective in nature and had a predominately male population. CONCLUSIONS: The progression of untreated high-grade squamous intraepithelial lesion to anal squamous cell carcinoma approximates 1% per patient-year. Anal squamous cell carcinoma developing under surveillance tends to be of an earlier stage and to require fewer major interventions than anal squamous cell carcinoma presenting de novo. Cancer-specific mortality was lower for malignancies that developed under surveillance. We suggest that expectant management of patients with high-grade squamous intraepithelial lesion is a rational strategy for preventing anal cancer morbidity. See Video Abstract at http://links.lww.com/DCR/A699.

Precision Medicine for CRC Patients in the Veteran Population: State-of-the-Art, Challenges and Research Directions.

Colorectal cancer (CRC) accounts for ~9% of all cancers in the Veteran population, a fact which has focused a great deal of the attention of the VA's research and development efforts. A field-based meeting of CRC experts was convened to discuss both challenges and opportunities in precision medicine for CRC. This group, designated as the VA Colorectal Cancer Cell-genomics Consortium (VA4C), discussed advances in CRC biology, biomarkers, and imaging for early detection and prevention. There was also a discussion of precision treatment involving fluorescence-guided surgery, targeted chemotherapies and immunotherapies, and personalized cancer treatment approaches. The overarching goal was to identify modalities that might ultimately lead to personalized cancer diagnosis and treatment. This review summarizes the findings of this VA field-based meeting, in which much of the current knowledge on CRC prescreening and treatment was discussed. It was concluded that there is a need and an opportunity to identify new targets for both the prevention of CRC and the development of effective therapies for advanced disease. Also, developing methods integrating genomic testing with tumoroid-based clinical drug response might lead to more accurate diagnosis and prognostication and more effective personalized treatment of CRC.

Twenty Years of a Veterans' Spinal Cord Injury Colorectal Clinic: Flexible Sigmoidoscopy and Multiple Hemorrhoid Ligation.

BACKGROUND: Colorectal and anal problems arise in chronic spinal cord injury care. We review 20 years of experience in a colorectal clinic at a veterans medical center treating mostly male veterans who have spinal cord injury. OBJECTIVE: We aim to show the results of colorectal interventions in a population with chronic spinal cord injury. DESIGN: This study is a retrospective records review. SETTINGS: This study was conducted at a Department of Veterans Affairs regional spinal cord injury center. PATIENTS: Six hundred forty-one individuals (625 males) made 1208 visits. Mean age was 56 ± 13 years; ages ranged from 21 to 90 years. INTERVENTIONS: Flexible sigmoidoscopy was done for diagnosis and screening, and hemorrhoid ligation was performed for symptomatic hemorrhoids. MAIN OUTCOME MEASURES: The primary outcomes measured were the frequency, timing, and results of procedures. RESULTS: Five hundred forty-eight people had 781 flexible sigmoidoscopies. At first examination, mean age was 65 ± 12 and the duration of injury was 19 ± 15 years. Sixty examinations (7.7%) displayed poor preparation. The interval between adequate-prepared examinations was 5.7 ± 2.0 years. The adenoma detection rate was 4.7%. Two hundred fifteen people had 406 hemorrhoid ligations. At first banding, the mean age was 52 ± 13 and the duration of injury was 20 ± 15 years. Mean number of ligations per procedure was 4.9 ± 2.0; a range of 1 to 20. Nine hemorrhoid operations were done in this period. Regarding the futility of procedures, 250 people died, with a mean age at death of 69 ± 11. The median time between any procedure and death was 4.4 years. Seventeen procedures were done within 6 months of death; these deaths were either unexpected or because of conditions identified at or after the procedure. LIMITATIONS: This was a retrospective review of a single institution, it involved a mostly male population, and it used a subjective assessment of bowel preparation. CONCLUSIONS: In a spinal cord injury colorectal clinic, sigmoidoscopy can keep screening current, with an acceptable level of poor preparation. The adenoma detection rate may or may not be adequate. Hemorrhoid ligation can be expanded beyond its limits in the non-spinal cord-injured population, including multiple and external banding, taking the place of an operation in most cases. These procedures are well tolerated and rarely futile.

Preoperative malnutrition assessments as predictors of postoperative mortality and morbidity in colorectal cancer: an analysis of ACS-NSQIP.

BACKGROUND: Nutritional status is an important factor in predicting the risk associated with surgery for cancer patients. This is especially true in colorectal cancer. Many nutritional assessments are used in clinical practice, but those assessments are rarely evaluated for their ability to predict postoperative outcome. METHODS: This is a retrospective, multi-institutional study of the ACS-NSQIP database, investigating preoperative nutrition status and its association with postoperative mortality and morbidity. RESULTS: The prevalence of malnutrition is higher in colorectal cancer, when compared with other most common cancers. Among 42,483 colorectal cancer patients postoperative mortality was significantly associated with hypoalbuminemia (hazard ratio = 3.064, p < 0.001), body weight loss (hazard ratio = 1.229, p = 0.033) and body mass index of <18.5 kg/m(2) (hazard ratio = 1.797, p < 0.001). Only hypoalbuminemia significantly predicted all postoperative complications, even in further multivariate logistic regression analyses (p < 0.001). Multiple regression analysis showed that the hypoalbuminemia group had the highest coefficient in significant association with length of total hospital stay (B = 3.585, p < 0.001) and overall complication (B = 0.119, p < 0.001). CONCLUSIONS: In colorectal cancer, malnutrition significantly contributes to postoperative mortality, morbidity and length of total hospital stay. Hypoalbuminemia, with levels below 3.5 g/dl, serves as an excellent assessment tool and preoperative predictor of postoperative outcomes.

ACG clinical guideline: management of benign anorectal disorders.

These guidelines summarize the definitions, diagnostic criteria, differential diagnoses, and treatments of a group of benign disorders of anorectal function and/or structure. Disorders of function include defecation disorders, fecal incontinence, and proctalgia syndromes, whereas disorders of structure include anal fissure and hemorrhoids. Each section reviews the definitions, epidemiology and/or pathophysiology, diagnostic assessment, and treatment recommendations of each entity. These recommendations reflect a comprehensive search of all relevant topics of pertinent English language articles in PubMed, Ovid Medline, and the National Library of Medicine from 1966 to 2013 using appropriate terms for each subject. Recommendations for anal fissure and hemorrhoids lean heavily on adaptation from the American Society of Colon and Rectal Surgeons Practice Parameters from the most recent published guidelines in 2010 and 2011 and supplemented with subsequent publications through 2013. We used systematic reviews and meta-analyses when available, and this was supplemented by review of published clinical trials.

Migration of vascular embolisation material from the intravascular space to surrounding interstitial tissues in arteriovenous malformations.

We present the case of a young man active duty in the military who initially presented with pelvic pain and fullness during sexual activity. Extensive workup showed a large pelvic arteriovenous malformation (AVM). He underwent over 10 interventional radiology procedures to embolise his AVM and suffered multiple postoperative complications resulting in exploratory laparotomies, bowel resections and ultimately a colostomy. Six years after his embolisation procedures, he was found on imaging to have gluteal fluid collections with metallic particles, presumed to be migrated Onyx from his angioembolisations as a result of non-target embolisation. Current literature does not document other instances of Onyx material migrating from an intravascular source to interstitial tissue.

Recent smoking is a risk factor for anal abscess and fistula.

BACKGROUND: Smoking is a risk factor for inflammatory, fistulizing cutaneous diseases. It seems reasonable that smoking might be a risk factor for anal abscess/fistula. OBJECTIVE: This study aimed to test the hypothesis that recent smoking is a risk factor for development of anal abscess/fistula. DESIGN: This is a case-control study. SETTINGS: This study was conducted at a Department of Veterans Affairs general surgical clinic. PATIENTS: Included in the study were 931 patients visiting the general surgical clinic over a 6-month period. INTERVENTIONS: A tobacco use questionnaire was administered. MAIN OUTCOME MEASURES: Patients with anal abscess/fistula history were compared with controls, who had all other general surgical conditions. To investigate the temporal relation between smoking and the clinical onset of anal abscess/fistula, we compared the group consisting of current smokers and former smokers who had recently quit, against the group consisting of nonsmokers and former smokers who had quit a longer time ago (ie, not recently). We excluded patients with IBD and HIV. RESULTS: Cases and controls were comparable in age (57 and 59 y) and sex (93% and 97% male). After exclusions, there were 74 anal abscess/fistula cases and 816 controls. Among the anal abscess/fistula cases, 36 patients had smoked within 1 year before the onset of anal abscess/fistula symptoms, and 38 had not smoked within the prior year; among controls, 249 had smoked within 1 year before seeking surgical treatment, and 567 had not (OR 2.15, 95% CI 1.34-3.48, 2-tail P = .0025). Using a 5-year cutoff for recent smoking, the association was less pronounced but still significant (OR 1.72, 95% CI 1.03-2.86, P = .0375), and the association was insignificant at 10 years (OR 1.34, 95% CI 0.78-2.21, P = .313). LIMITATIONS: Limitations of the study included self-selection bias, recall bias, convenience sample, and noninvestigation of the dose-response relationship. CONCLUSIONS: Recent smoking is a risk factor for anal abscess/fistula development. As in other smoking-related diseases, the influence of smoking as a risk factor for anal abscess/fistula diminishes to baseline after 5 to 10 years of smoking cessation. Anal abscess/fistula can be added to the list of chronic, inflammatory cutaneous conditions associated with smoking.

Outcomes for a Large Cohort of Patients with Rectal Neuroendocrine Tumors: an Analysis of the National Cancer Database.

BACKGROUND: Rectal neuroendocrine tumors comprise 20% of neuroendocrine tumors in the alimentary tract, but there is controversy surrounding the optimal management of this disease. The purpose of this study is to better define treatment for patients with rectal neuroendocrine tumors. METHODS: Using the National Cancer Database, we analyzed patients with rectal neuroendocrine tumors between 2004 and 2015. Patients with metastatic disease and missing treatment data were excluded. We examined overall survival stratified by tumor size, treatment type, and presence of positive lymph nodes using Kaplan-Meier analysis with log-rank test. Cox proportional hazard regression model was performed to identify factors associated with overall survival. RESULTS: In total, 17,448 patients with rectal neuroendocrine tumors were identified; 16,531 of these patients met inclusion criteria. The majority of patients had tumors ≤ 10 mm (9216 patients, 79.8%), and approximately 90% underwent local excision. The probability of 5-year overall survival was significantly higher for patients with smaller tumors (≤ 10 mm: 94.1% 11-20 mm: 85.7%, > 20 mm: 71.8%; p < 0.001) and those with no positive lymph nodes (91.4% versus 53.3%, p < 0.001). The probability of 5-year overall survival differed based on treatment modality (local excision: 93.6%, radical resection: 79.1%, observation alone: 77.1%; p < 0.001). On multivariable Cox regression, when compared to local excision, radical resection was not associated with a difference in overall survival but observation alone was associated with significantly worse OS (HR = 2.750, p < 0.001). CONCLUSIONS: There is a significant difference in overall survival between patients who underwent local excision versus observation alone. Excision of the tumor should be offered to all patients with rectal neuroendocrine tumors who are appropriate surgical candidates, regardless of the tumor size.