Venous invasion detectable only by elastic stain shows weak prognostic value in colon cancer.

AIMS: Large venous invasion (VI) is prognostically significant in colon cancer. The increased use of elastic stains by pathologists results in higher VI detection rates compared to routine stains alone. This study assesses the prognostic value of VI detected by elastic versus routine stains. METHODS AND RESULTS: Colon cancers resected between 2014 and 2017 underwent pathology slide review for VI. Cases without VI on routine stain were stained by elastic trichrome and re-examined. Demographic, clinical, pathological and outcome data were gathered by retrospective review. Kaplan-Meier curves with log-rank tests were performed for survival categorised by VI status. Cox regression was performed for multivariate analysis. Of 277 cases, 97 (35%) showed VI by routine stain alone, with an additional 58 (21%) discovered by subsequent elastic stains. Thus, elastic trichrome increased VI detection by 60%. However, only VI detected by routine stain showed worse overall survival (P < 0.001). VI detected by elastic stain only was not prognostically different from cases without VI (P = 0.428). For stage 2 cancers, VI was not prognostically significant regardless of method of detection. For stage 3 cases, only VI detected by routine stain was prognostic for overall survival (P = 0.002) with a hazard ratio of 4.04 by multivariate regression (P = 0.028). CONCLUSIONS: VI detectable only by elastic stains do not show prognostic significance for survival in colon cancer. For pathologists with high baseline VI detections rates on routine stain, reflexive use of elastic stain may be of limited value.

A systematic review and meta-analysis of oncological outcomes with transanal total mesorectal excision for rectal cancer.

AIM: Transanal total mesorectal (taTME) excision is a method used to assist in the radical removal of the rectum. By adopting the concept of natural orifice surgery, it offers potential benefits over conventional techniques. Early enthusiasm for this strategy led to its rapid and widespread adoption. The imposing of a local moratorium was precipitated by the discovery in Norway of an uncommon multifocal pattern of locoregional recurrence. The aim of this systematic review and meta-analysis was to determine the incidence of local recurrence after taTME for rectal cancer. METHOD: Conforming to the Cochrane Handbook for Systematic Reviews of Interventions and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines checklist, a systematic review and meta-analysis was conducted. This included case series and comparative studies between taTME and preferentially laparoscopic procedures published between 2010 and 2021. RESULTS: There were a total of 1175 studies retrieved. After removal and screening for quality and relevance, the final analysis contained 40 studies. The local recurrence rate following taTME was 3.4% (95% CI 2.9%-3.9%, I2 = 0%) in 4987 patients with follow-up durations ranging from 0.7 to 5.5 years. Compared with laparoscopic TME, local recurrence was not statistically different for the taTME group (p = 0.076); however, it was less probable (OR = 0.51, 95% CI 0.24-1.09, I2 = 0%). Systemic recurrence and circumferential resection margin status were secondary outcomes; however, the differences were not statistically significant. CONCLUSION: Our data suggest that the local recurrence for regular laparoscopic and transanal TME surgeries may be comparable, suggesting that taTME can be performed without influencing locoregional oncological outcomes in patients treated at specialized institutions and who have been cautiously selected.

The impact of robotic rectal cancer surgery at a Canadian regional cancer centre: a retrospective cohort study.

BACKGROUND: Although robotic surgery has several advantages over other minimally invasive surgery (MIS) techniques for rectal cancer surgery, the uptake in Canada has been limited owing to a perceived increase in cost and lack of training. The objective of this study was to determine the impact of access to robotic surgery in a Canadian setting. METHODS: We conducted a retrospective cohort study involving consecutive adults undergoing surgical resection for rectal cancer between 2017 and 2020. The primary exposure was access to robotic surgery. Outcomes included MIS utilization, short-term outcomes, total cost of care, and quality of surgical resection. We completed univariate and multivariate analyses. RESULTS: We included 171 individuals in this cohort study (85 in the prerobotic period and 86 in the robotic period). The 2 groups had similar baseline characteristics. A higher proportion of individuals underwent successful MIS in the robotic phase (86% v. 46%, p < 0.001). Other benefits included a shorter mean length of hospital stay (5.1 d v. 9.2 d, p < 0.001). The quality of surgical resection was similar between groups. The total cost of care was $16 746 in the robotic period and $18 808 in the prerobotic period (mean difference -$1262, 95% confidence interval -$4308 to $1783; p = 0.4). CONCLUSION: Access to robotic rectal cancer surgery increased successful completion of MIS and shortened hospital stay, with a similar total cost of care. Robotic rectal cancer surgery can enhance patient outcomes in the Canadian setting.

Incidence, Timing, and Outcomes of Venous Thromboembolism in Patients Undergoing Surgery for Esophagogastric Cancer: A Population-Based Cohort Study.

BACKGROUND: Abdominal surgery and chemotherapy are well-established risk factors for venous thromboembolism (VTE) in patients with cancer, but their specific contribution in patients with esophageal and gastric cancer is unclear. We aim to quantify the risk of VTE, identify risk factors associated with VTE, and determine the association between VTE and survival in patients undergoing surgery for esophageal or gastric cancer. METHODS: A retrospective, population-based cohort study was conducted using linked administrative healthcare databases. We used the Ontario Cancer Registry to identify patients with esophageal or gastric cancer between January 1, 2007 and December 31, 2016 who underwent surgical resection. Incidence of first VTE event was identified using International Classification of Diseases 9 and 10 codes. VTE incidence was calculated at clinically relevant time points 180 days before and after surgery. Logistic regression was used to identify factors associated with VTE with odds ratios (OR) and 95% confidence intervals (CI) reported. Cox proportional hazards regression models were used to estimate associations between covariates and survival. Kaplan-Meier method was used to compare overall (OS) and cancer-specific survival (CSS) by VTE status. RESULTS: A total of 4894 patients had esophagectomy or gastrectomy, of which 8% (n = 383/4894) had VTE. VTE risk was 2.5% (n = 123/4894) 180 days before surgery, 2.8% (n = 138/4894) within 30 days of surgery, and 2.5% (n = 122/4894) from 31 to ≤ 180 days after surgery. Of the patients with VTE within 30 days of surgery, 34% (n = 47/138) were diagnosed after discharge from hospital. Receipt of preoperative chemotherapy was associated with VTE 180 days before surgery (odds ratio [OR] 3.84, 95% confidence interval [CI] 2.41, 6.11). Increased hospital length of stay (LOS) was associated with VTE 30 days after surgery (OR 1.08, 95% CI 1.02, 1.14, per week). Patients with VTE had inferior median OS and CSS (2.2 vs. 3.7 years; 2.3 vs. 4.4 years, respectively). In adjusted models VTE was associated with inferior OS (HR 1.36, 95% CI 1.13, 1.63) and CSS (HR 1.42, 95% CI 1.16, 1.75). CONCLUSIONS: The highest risk of VTE is within 30 days of surgery with one third of patients diagnosed after discharge from hospital. Longer hospital LOS and receipt of preoperative chemotherapy are associated with increased risk of VTE. VTE is an independent risk factor for inferior survival in patients with esophageal or gastric cancer.

Transanal total mesorectal excision for abdominoperineal resection is associated with poor oncological outcomes in rectal cancer patients: A word of caution from a multicentric Canadian cohort study.

AIM: The main objective of this study was to compare the oncological outcomes of patients undergoing abdominoperineal resection (APR) versus low anterior resection (LAR) through a transanal total mesorectal excision (taTME) approach. METHOD: A total of 360 adult patients with a diagnosis of rectal cancer were enrolled at participating centres from the Canadian taTME Expert Collaboration. Forty-three patients received taTME-APR and received 317 taTME-LAR. Demographic, operative, pathological and follow-up data were collected and merged into a single database. Results are presented as hazard ratio (HR) and 95% confidence interval. All analyses were performed in the R environment (v.3.6). RESULTS: The proportion of patients with a positive circumferential radial margin status was higher in the taTME-APR group than the taTME-LAR group (21% vs. 9%, p = 0.001). Complete TME was achieved in 91% of those undergoing APR compared with 96% of those undergoing LAR (p = 0.25). APR was associated with a greater rate of local recurrence relative to LAR, although it was not significant [crude HR = 3.53 (95% CI 0.92-13.53)]. Circumferential margin positivity was significantly associated with a higher rate of systemic recurrence [crude HR = 3.59 (95% CI 1.38-9.3)]. CONCLUSION: Our results demonstrate inferior outcomes in those undergoing taTME-APR compared with taTME-LAR. The use of this technique for this particular indication needs to be carefully considered.

The impact of robotic surgery on a tertiary care colorectal surgery program, an assessment of costs and short term outcomes: A Canadian perspective.

BACKGROUND: Robotic surgery for colorectal pathology has gained interest as it can overcome technical challenges and limitations of traditional laparoscopic surgery. A lack of training and costs have been cited as reasons for limiting its use in Canada. The objective of this paper was to assess the impact of robotic surgery on outcomes and costs in a Canadian setting. METHODS: This is a retrospective study of consecutive patients undergoing left sided colorectal surgery ("Pre-Robotic Phase" n = 145 vs. "Post Robotic Phase" n = 150) and a single tertiary care centre in Ontario, Canada. Utilization and success of minimally invasive surgery (MIS), length of stay, complications and hospital costs were compared. Univariate and Multivariate analysis was used for these comparisons. RESULTS: Characteristics, diagnosis and type of resection were similar between groups. Robotic Implementation resulted in higher rates of successful MIS (i.e. attempt at MIS without conversion) (85% vs. 47%, P < 0.001), shorter mean length of stay (4.7 days vs. 8.4 days, P < 0.001), and similar mean operative times (3.9 h vs. 3.9 h, P = 0.93). Emergency Department visits were fewer in the Robotic Phase (24% vs. 34%, P = 0.04), with no difference in readmission, anastomotic leak or unplanned reoperation. After robotic implementation, the mean total hospital costs decreased, but this was not statistically significant (-$1453, 95% CI -$3974 to +$1068, P = 0.25). Regression analysis, adjusting for age, gender, obesity, ASA and procedure showed similar findings (Robotic Phase -$657, 95% CI -$3038 to +$1724, vs Pre Robotic Phase [Reference], P = 0.59). INTERPRETATION: Implementation of a robotic colorectal surgery program in a Canadian tertiary care centre showed improved clinical outcomes, without a significant increase in the cost of care. Although this study is from a single institution, we have demonstrated that robotic colorectal surgery is feasible and can be cost effective in the right setting.

SAGES TAVAC safety and efficacy analysis confocal laser endomicroscopy.

BACKGROUND: Confocal laser endomicroscopy (CLE) is a novel endoscopic adjunct that allows real-time in vivo histological examination of mucosal surfaces. By using intravenous or topical fluorescent agents, CLE highlights certain mucosal elements that facilitate an optical biopsy in real time. CLE technology has been used in different organ systems including the gastrointestinal tract. There has been numerous studies evaluating this technology in gastrointestinal endoscopy, our aim was to evaluate the safety, value, and efficacy of this technology in the gastrointestinal tract. METHODS: The Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Technology and Value Assessment Committee (TAVAC) performed a PubMed/Medline database search of clinical studies involving CLE in May of 2018. The literature search used combinations of the keywords: confocal laser endomicroscopy, pCLE, Cellvizio, in vivo microscopy, optical histology, advanced endoscopic imaging, and optical diagnosis. Bibliographies of key references were searched for relevant studies not covered by the PubMed search. Case reports and small case series were excluded. The manufacturer's website was also used to identify key references. The United States Food and Drug Administration (U.S. FDA) Manufacturer And User facility and Device Experience (MAUDE) database was searched for reports regarding the device malfunction or injuries. RESULTS: The technology offers an excellent safety profile with rare adverse events related to the use of fluorescent agents. It has been shown to increase the detection of dysplastic Barrett's esophagus, gastric intraepithelial neoplasia/early gastric cancer, and dysplasia associated with inflammatory bowel disease when compared to standard screening protocols. It also aids in the differentiation and classification of colorectal polyps, indeterminate biliary strictures, and pancreatic cystic lesions. CONCLUSIONS: CLE has an excellent safety profile. CLE can increase the diagnostic accuracy in a number of gastrointestinal pathologies.

A Snapshot of the International Views of the Treatment of Rectal Cancer Patients, a Multi-regional Survey: International Tendencies in Rectal Cancer.

BACKGROUND: Management of rectal cancer has a number of potentially appropriate alternatives for each patient. Despite acceptance of standards, practices may vary among regions. There is significant paucity of data in this area. The objective was to create a snapshot of the regional differences. DESIGN: This online survey included 10 questions. Enquiries focused on controversial topics, on surgeon and hospital volume, surgical margins, appropriateness of surgical approaches and techniques, watch-and-wait strategies, and total neoadjuvant therapy. Major colorectal surgery societies around the world were asked to invite their members to complete the survey. OUTCOME MEASURES: Frequency of responses across regions within each question was compared by Fisher's exact test. RESULTS: Seven hundred and fifty-three participants from 60 countries responded. Eight regions were identified, and four had sufficient representation for comparisons. Similarities and differences in the therapies among these regions were identified. Robotic surgery penetrance is higher in North America, and watch and wait is more accepted in South America. Patients in Oceania are more likely to be diverted; Europe has more usage of taTME. DISCUSSION: This online survey was practical as a mean to provide a rapid assessment of the international picture on consistency and variability of rectal cancer patients' care, and to potentially identify opportunities to standardized care to patients. Medical surveys have inherent limitations; pertinence to our study is selection bias. CONCLUSIONS: The management of rectal cancer varies among different regions. Identification of differences is important when considering global efforts to improve management and interpret data.

Current Evidence for Minimally Invasive Surgery During the COVID-19 Pandemic and Risk Mitigation Strategies: A Narrative Review.

OBJECTIVE: Our objective was to review the literature surrounding the risks of viral transmission during laparoscopic surgery and propose mitigation measures to address these risks. SUMMARY BACKGROUND DATA: The SARS-CoV-2 pandemic has caused surgeons the world over to re-evaluate their approach to surgical procedures given concerns over the risk of aerosolization of viral particles and exposure of operating room staff to infection. International society guidelines advise against the use of laparoscopy; however, the evidence on this topic is scant and recommendations are based on the perceived most cautious course of action. METHODS: We conducted a narrative review of the existing literature surrounding the risks of viral transmission during laparoscopic surgery and balance these risks against the benefits of minimally invasive approaches. We also propose mitigation measures to address these risks that we have adopted in our institution. RESULTS AND CONCLUSION: While it is currently assumed that open surgery minimizes operating room staff exposure to the virus, our findings reveal that this may not be the case. A well-informed, evidence-based opinion is critical when making decisions regarding which operative approach to pursue, for the safety and well-being of the patient, the operating room staff, and the healthcare system at large. Minimally invasive surgical approaches offer significant advantages with respect to both patient care, and the mitigation of the risk of viral transmission during surgery, provided the appropriate equipment and expertise are present.

Canadian taTME expert collaboration (CaTaCO) position statement.

INTRODUCTION: Transanal total mesorectal excision (taTME) is a novel approach to surgery for rectal cancer. The technique has gained significant popularity in the surgical community due to the promising ability to overcome technical difficulties related to the access of the distal pelvis. Recently, Norwegian surgeons issued a local moratorium related to potential issues with the safety of the procedure. Early adopters of taTME in Canada have recognized the need to create guidelines for its adoption and supervision. The objective of the statement is to provide expert opinion based on the best available evidence and authors' experience. METHODS: The procedure has been performed in Canada since 2014 at different institutions. In 2016, the first Canadian taTME congress was held in the city of Toronto, organized by two of the authors. In early 2019, a multicentric collaborative was established [The Canadian taTME expert Collaboration] which aimed at ensuring safe performance and adoption of taTME in Canada. Recently surgeons from 8 major Canadian rectal cancer centers met in the city of Toronto on December 7 of 2019, to discuss and develop a position statement. There in person, meeting was followed by 4 rounds of Delphi methodology. RESULTS: The generated document focused on the need to ensure a unified approach among rectal cancer surgeons across the country considering its technical complexity and potential morbidity. The position statement addressed four domains: surgical setting, surgeons' requirements, patient selection, and quality assurance. CONCLUSIONS: Authors agree transanal total mesorectal excision is technically demanding and has a significant risk for morbidity. As of now, there is uncertainty for some of the outcomes. We consider it is possible to safely adopt this operation and obtain adequate results, however for this purpose it is necessary to meet specific requirements in different domains.

Laparoscopic colectomy: trends in implementation in Canada and globally

Summary: Comparisons with other high-income countries suggest that Canada has been slower to adopt laparoscopic colectomy (LC). The Canadian Association of General Surgeons sought to evaluate the barriers to adoption of laparoscopic colon surgery and to propose potential intervention strategies to enhance the use of the procedure. Given the clinical benefits of laparoscopic surgery for patients, the increasing needs for surgical care and the desire of Canadian general surgeons to advance their specialty and enhance the care of their patients, it is an important priority to improve the utilization of LC.

Transanal minimally invasive surgery for benign large rectal polyps and early malignant rectal cancers: experience and outcomes from the first Canadian centre to adopt the technique.

BACKGROUND: Transanal minimally invasive surgery (TAMIS) has emerged as a relatively new technique in treating early cancer and benign lesion of the rectum. The technique is likely to be widely adopted, surpassing other comparable techniques owing to its simple setup and cost-effectiveness. We assessed the outcomes of TAMIS at our centre. METHODS: We retrospectively reviewed prospectively collected data on 50 patients who underwent TAMIS for benign, malignant T1 or T2 cancers that were unfit for radical surgery over a 4-year period. Outcomes, including 30-day complications and recurrence, as well as our ability to implement and integrate this technique at our centre were assessed. RESULTS: All 50 TAMIS procedures were successful. The average lesion was 7 cm from the anal verge, the average tumour size was 2.5 cm, the average duration of surgery was 73 minutes, the average length of stay was 1.1 days, and the margin negativity was 84%. Major indications in our series included 25 lesions that were too large for endoscopic resection, 14 early cancers or high-grade dysplasia, 10 margin checks postpolypectomy, 6 cases of recurrent polyposis, and 4 medically unfit patients. There were no deaths. The rate of short-term complications, including rectal bleeding, reoperation and urinary retention, was 16%. The rate of long-term complications, including anal incontinence and stenosis, was 4%. Benign and malignant recurrence rates were 2% and 6%, respectively. Overall long-term requirement for invasive procedures, low anterior resection or abdominoperineal resection, was 12%. CONCLUSION: To our knowledge, this is the first Canadian study showing TAMIS to be an efficient and safe procedure for the treatment of well-selected patients with rectal lesions. Outcomes from our centre are comparable with those found in the literature.

CONTEXTE: La chirurgie transanale mini-invasive (TAMIS) s'est imposée comme une technique relativement nouvelle pour le traitement du cancer précoce et des lésions bénignes du rectum. La technique est en voie d'être adoptée à grande échelle, voire de supplanter d'autres techniques comparables, en raison de sa mise en place facile et de sa rentabilité. Nous avons évalué les résultats de la technique TAMIS dans notre centre. MÉTHODES: Nous avons fait une analyse rétrospective de données recueillies de façon prospective sur 50 patients traités par TAMIS pour cause de cancer T1 ou T2 malin ou bénin et non candidats à la chirurgie radicale, sur une période de 4 ans. Nous avons évalué les résultats, y compris les complications et la récidive sur 30 jours, ainsi que notre capacité d'adopter et d'intégrer cette technique dans notre centre. RÉSULTATS: Les 50 chirurgies TAMIS furent une réussite. La taille moyenne de la lésion était de 7 cm à partir de la marge anale, la taille moyenne de la tumeur était de 2,5 cm, la durée moyenne de la chirurgie était de 73 minutes, la durée moyenne d'hospitalisation était de 1,1 jour et le taux de marges négatives était de 84 %. Parmi les principales indications dans notre série, mentionnons 25 lésions trop grandes pour la résection endoscopique; 14 cancers précoces ou dysplasies de haut grade; 10 vérifications des marges post-polypectomie, 6 cas de récidive de la polypose et 4 patients non candidats au traitement médical. Il n'y a eu aucun décès. Le taux de complications à court terme, incluant le saignement rectal, les interventions répétées et la rétention urinaire, était de 16 %. Le taux de complications à long terme, incluant l'incontinence anale et la sténose anale, était de 4 %. Les taux de récidive bénigne et maligne étaient respectivement de 2 % et de 6 %. Le taux global de besoin à long terme d'une intervention effractive, d'une résection antérieure basse ou d'une résection abdominopérinéale était de 12 %. CONCLUSION: À notre connaissance, notre étude est la première au Canada qui démontre que la technique TAMIS est une intervention efficace et sécuritaire pour le traitement de patients soigneusement choisis atteints de lésions rectales. Les résultats de notre centre sont comparables à ceux trouvés dans la littérature.

Emergency Colorectal Surgery in Those with Cirrhosis: A Population-based Study Assessing Practice Patterns, Outcomes and Predictors of Mortality.

Background: Those with cirrhosis who require emergency colorectal surgery are at risk for poor outcomes. Although risk predictions models exists, these tools are not specific to colorectal surgery, nor were they developed in a contemporary setting. Thus, the objective of this study was to assess the outcomes in this population and determine whether cirrhosis etiology and/or the Model for End Stage Liver Disease (MELD-Na) is associated with mortality. Methods: This population-based study included those with cirrhosis undergoing emergent colorectal surgery between 2009 and 2017. All eligible individuals in Ontario were identified using administrative databases. The primary outcome was 90-day mortality. Results: Nine hundred and twenty-seven individuals (57%) (male) were included. The most common cirrhosis etiology was non-alcoholic fatty liver disease (NAFLD) (50%) and alcohol related (32%). Overall 90-day mortality was 32%. Multivariable survival analysis demonstrated those with alcohol-related disease were at increased risk of 90-day mortality (hazards ratio [HR] 1.53, 95% confidence interval [CI] 1.2-2.0 vs. NAFLD [ref]). Surgery for colorectal cancer was associated with better survival (HR 0.27, 95%CI 0.16-0.47). In the subgroup analysis of those with an available MELD-Na score (n = 348/927, 38%), there was a strong association between increasing MELD-Na and mortality (score 20+ HR 6.6, 95%CI 3.9-10.9; score 10-19 HR 1.8, 95%CI 1.1-3.0; score <10 [ref]). Conclusion: Individuals with cirrhosis who require emergent colorectal surgery have a high risk of postoperative complications, including mortality. Increasing MELD-Na score is associated with mortality and can be used to risk stratify individuals.

Metabolically Active Zones Involving Fatty Acid Elongation Delineated by DESI-MSI Correlate with Pathological and Prognostic Features of Colorectal Cancer.

Colorectal cancer (CRC) is the second leading cause of cancer deaths. Despite recent advances, five-year survival rates remain largely unchanged. Desorption electrospray ionization mass spectrometry imaging (DESI) is an emerging nondestructive metabolomics-based method that retains the spatial orientation of small-molecule profiles on tissue sections, which may be validated by 'gold standard' histopathology. In this study, CRC samples were analyzed by DESI from 10 patients undergoing surgery at Kingston Health Sciences Center. The spatial correlation of the mass spectral profiles was compared with histopathological annotations and prognostic biomarkers. Fresh frozen sections of representative colorectal cross sections and simulated endoscopic biopsy samples containing tumour and non-neoplastic mucosa for each patient were generated and analyzed by DESI in a blinded fashion. Sections were then hematoxylin and eosin (H and E) stained, annotated by two independent pathologists, and analyzed. Using PCA/LDA-based models, DESI profiles of the cross sections and biopsies achieved 97% and 75% accuracies in identifying the presence of adenocarcinoma, using leave-one-patient-out cross validation. Among the m/z ratios exhibiting the greatest differential abundance in adenocarcinoma were a series of eight long-chain or very-long-chain fatty acids, consistent with molecular and targeted metabolomics indicators of de novo lipogenesis in CRC tissue. Sample stratification based on the presence of lympovascular invasion (LVI), a poor CRC prognostic indicator, revealed the abundance of oxidized phospholipids, suggestive of pro-apoptotic mechanisms, was increased in LVI-negative compared to LVI-positive patients. This study provides evidence of the potential clinical utility of spatially-resolved DESI profiles to enhance the information available to clinicians for CRC diagnosis and prognosis.

Effect of low-level creatinine clearance on short-term postoperative complications in patients with colorectal cancer.

Background: Renal function is closely related to cancer prognosis. Since preoperative renal insufficiency has been identified as a risk factor for postoperative complications, this study aimed to investigate the effect of preoperative creatinine clearance rate (CrCl) on short-term prognosis of patients undergoing colorectal surgery. Methods: A retrospective analysis was conducted of the electronic health records of 526 adult patients who underwent elective colorectal cancer (CRC) surgery from September 2014 to February 2019 at the First Affiliated Hospital of Wenzhou Medical University. Cases were divided into two groups according to CrCl level and clinical variables were compared. Risk factors associated with postoperative complications were evaluated through univariate and multivariate logistic regression analyses. Results: A total of 526 patients met the inclusion criteria. The overall rate of postoperative complications was 28.14%. Overall, the incidence of postoperative complications was significantly higher in the low CrCl patients. A low-level CrCl, multi-organ combined resection, and Charlson comorbidity index (CCI) were independent risk factors for short-term complications in patients with CRC. However, a low CrCl was identified as an independent risk factor for short-term postoperative complications in elderly, but not young patients in a subgroup analysis. Conclusions: Preoperative low-level CrCl, multi-organ combined resection, and CCI were significant risk factors of postoperative complications in CRC patients. Preoperative low-level CrCl and multi-organ combined resection has a poor prognostic impact for elderly patients with CRC. These findings should have important implications for health care decision-making among patients with CRC who are at higher risk for post-operative complications.

Neoadjuvant Chemotherapy, Excision, and Observation for Early Rectal Cancer: The Phase II NEO Trial (CCTG CO.28) Primary End Point Results.

PURPOSE: Organ-sparing therapy for early-stage I/IIA rectal cancer is intended to avoid functional disturbances or a permanent ostomy associated with total mesorectal excision (TME). The objective of this phase II trial was to determine the outcomes and organ-sparing rate of patients with early-stage rectal cancer treated with neoadjuvant chemotherapy followed by transanal excision surgery (TES). METHODS: This phase II trial included patients with clinical T1-T3abN0 low- or mid-rectal adenocarcinoma eligible for endoscopic resection who were treated with 3 months of chemotherapy (modified folinic acid-fluorouracil-oxaliplatin 6 or capecitabine-oxaliplatin). Those with evidence of response proceeded to transanal endoscopic surgery 2-6 weeks later. The primary end point was protocol-specified organ preservation rate, defined as the proportion of patients with tumor downstaging to ypT0/T1N0/X and who avoided radical surgery. RESULTS: Of 58 patients enrolled, all commenced chemotherapy and 56 proceeded to surgery. A total of 33/58 patients had tumor downstaging to ypT0/1N0/X on the surgery specimen, resulting in an intention-to-treat protocol-specified organ preservation rate of 57% (90% CI, 45 to 68). Of 23 remaining patients recommended for TME surgery on the basis of protocol requirements, 13 declined and elected to proceed directly to observation resulting in 79% (90% CI, 69 to 88) achieving organ preservation. The remaining 10/23 patients proceeded to recommended TME of whom seven had no histopathologic residual disease. The 1-year and 2-year locoregional relapse-free survival was, respectively, 98% (95% CI, 86 to 100) and 90% (95% CI, 58 to 98), and there were no distant recurrences or deaths. Minimal change in quality of life and rectal function scores was observed. CONCLUSION: Three months of induction chemotherapy may successfully downstage a significant proportion of patients with early-stage rectal cancer, allowing well-tolerated organ-preserving surgery.