Defining the learning curve for transanal total mesorectal excision for rectal adenocarcinoma.

BACKGROUND: Early observational data suggest that this approach is safe and feasible, but it is technically challenging and the learning curve has not yet been determined. The objective of this study was to determine the number of cases required achieve proficiency in transanal total mesorectal excision (TA-TME) for rectal adenocarcinoma. METHODS: All TA-TME cases performed from 03/2012-01/2017 at a single high-volume tertiary care institution for rectal adenocarcinoma were included. A cumulative summation (CUSUM) analysis was performed to determine the number of cases required to reach proficiency, defined as high-quality TME (complete or near-complete mesorectal envelope, negative distal (DRM), and circumferential resection (> 1 mm; CRM) margin). The acceptable and unacceptable rates of good quality TME were defined based on the incidence of high-quality TME in laparoscopic (unacceptable rate = 81.7%) and open (acceptable rate = 86.9%) arms of the ACOSOG Z6051 trial. RESULTS: A total of 87 consecutive cases were included with mean tumor height 4.8 cm (SD 2.7) and 80% (70/87) received neoadjuvant chemoradiation. Post-operative morbidity occurred in 44% (38/87) of cases, including 21% (18/87) readmissions. Median length of stay was 4 days [IQR 3-8]. A good quality TME was performed in 95% (83/87) of cases including 98% (85/87) negative CRM, 99% (86/87) negative DRM, and 99% (86/87) complete or near-complete mesorectal envelope. CUSUM analysis reported that the good quality TME rate reaches an acceptable rate after 51 cases overall, and 45 cases if abdominoperineal resections are excluded. CONCLUSION: TA-TME is a complex technique that requires a minimum of 45-51 cases to reach an acceptable incidence of high-quality TME and lower operative duration.

Achieving Opioid-Free Major Colorectal Surgery: Is It Possible?

INTRODUCTION: Opioid analgesia remains the mainstay of postoperative pain management strategies despite being associated with many adverse effects. A specific opioid-free protocol was designed to limit opioid usage. OBJECTIVE: The aim of the study was to audit the opioid-free rate within this protocol and to identify factors that might contribute to opioid-free surgery. METHODS: A retrospective study of all elective patients receiving abdominal colorectal surgery at the Center for Colon and Rectal Surgery at AdventHealth over 6 months was performed. Data on demographics, indications, perioperative management, outcomes, and inpatient and outpatient analgesic requirements were collected with subsequent analysis. RESULTS: A total of 303 consecutive patient records were analyzed. Approximately two-thirds (67.7%) of patients did not receive narcotics once they left the postanesthesia care unit as an inpatient. One-third of patients (32.0%) did not receive narcotic analgesia within 30 days of surgery as an outpatient. Patients in the opioid-free cohort were significantly older and had a malignant indication, less perioperative morbidity, and a shorter length of stay. CONCLUSIONS: Our study demonstrates that opioid-free analgesia is indeed possible in major colorectal surgery. Study limitations include its retrospective nature and that it is from a single institution. Despite these limitations, this study provides proof of concept that opioid-free colorectal surgery is possible within a specific protocol.

Surgical Quality Assurance in COLOR III: Standardization and Competency Assessment in a Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to develop an objective and reliable surgical quality assurance system (SQA) for COLOR III, an international multicenter randomized controlled trial (RCT) comparing transanal total mesorectal excision (TaTME) with laparoscopic approach for rectal cancer. BACKGROUND OF SUMMARY DATA: SQA influences outcome measures in RCTs such as lymph nodes harvest, in-hospital mortality, and locoregional cancer recurrence. However, levels of SQA are variable. METHOD: Hierarchical task analysis of TaTME was performed. A 4-round Delphi methodology was applied for standardization of TaTME steps. Semistructured interviews were conducted in round 1 to identify key steps and tasks, which were rated as mandatory, optional, or prohibited in rounds 2 to 4 using questionnaires. Competency assessment tool (CAT) was developed and its content validity was examined by expert surgeons. Twenty unedited videos were assessed to test reliability using generalizability theory. RESULTS: Eighty-three of 101 surgical tasks identified reached 70% agreement (26 mandatory, 56 optional, and 1 prohibited). An operative guide of standardized TaTME was created. CAT is matrix of 9 steps and 4 performance qualities: exposure, execution, adverse event, and end-product. The overall G-coefficient was 0.883. Inter-rater and interitem reliability were 0.883 and 0.986. To enter COLOR III, 2 unedited TaTME and 1 laparoscopic TME videos were submitted and assessed by 2 independent assessors using CAT. CONCLUSION: We described an iterative approach to develop an objective SQA within multicenter RCT. This approach provided standardization, the development of reliable and valid CAT, and the criteria for trial entry and monitoring surgical performance during the trial.

Minimally invasive surgery for stage III colon adenocarcinoma is associated with less delay to initiation of adjuvant systemic therapy and improved survival.

BACKGROUND: Minimally invasive surgery (MIS) may improve surgical recovery and reduce time to adjuvant systemic therapy after colon cancer resection. The objective of this study was to determine the effect of MIS on the initiation of adjuvant systemic therapy and survival in patients with stage III colon cancer. METHODS: The 2010-2014 National Cancer Database was queried for patients with resected stage III colon adenocarcinoma, and divided into MIS, which included laparoscopic and robotic approaches, and open surgery. Propensity-score matching was used to balanced open and MIS groups. The main outcome measures were delayed initiation of adjuvant systemic therapy (defined as > 8 weeks after surgery) and 5-year overall survival (OS). Multiple Cox regression was performed to identify independent predictors for 5-year OS, including an interaction between delayed systemic therapy and MIS, and adjusted for clustering at the hospital level. RESULTS: There were 86,680 patients that were included in this study. Overall, 45% (38,713) underwent MIS colectomy, of which 93% underwent laparoscopic and 7% robotic surgery. After matching, 33,183 open patients were balanced to 33,183 MIS patients. Patient, tumor, and facility characteristics were similar in the matched cohort. More patients in the MIS group received adjuvant therapy within 8 weeks of surgery (49% vs. 42%, p < 0.001), and fewer MIS patients did not receive any systemic therapy (30% vs. 35%, p < 0.001). Delayed initiation of systemic therapy > 8 weeks was associated with worse 5-year OS (HR 1.27, 95%CI 1.19-1.36). MIS was independently associated with improved survival (HR 0.92, 95%CI 0.86-0.97). This relationship remained even if 90-day mortality was excluded. CONCLUSIONS: MIS approaches are associated with less delay to the initiation of adjuvant systemic therapy and improved survival in patients with stage III colon adenocarcinoma. Surgeons should favor MIS approaches for the treatment of stage III colon adenocarcinoma whenever possible.

Transanal Minimally Invasive Surgery for Local Excision of Benign and Malignant Rectal Neoplasia: Outcomes From 200 Consecutive Cases With Midterm Follow Up.

OBJECTIVE: This study describes the outcomes for 200 consecutive transanal minimally invasive surgery (TAMIS) local excision (LE) for rectal neoplasia. BACKGROUND: TAMIS is an advanced transanal platform that can result in high quality LE of rectal neoplasia. METHODS: Consecutive patients from July 1, 2009 to December 31, 2015 from a prospective institutional registry were analyzed. Indication for TAMIS LE was endoscopically unresectable benign lesions or histologically favorable early rectal cancers. The primary endpoints were resection quality, neoplasia recurrence, and oncologic outcomes. Kaplan-Meier survival analyses were used to describe disease-free survival (DFS) for patients with rectal adenocarcinoma that did not receive immediate salvage radical surgery. RESULTS: There were 200 elective TAMIS LE procedures performed in 196 patients for 90 benign and 110 malignant lesions. Overall, a 7% margin positivity and 5% fragmentation rate was observed. The mean operative time for TAMIS was 69.5 minutes (SD 37.9). Postoperative morbidity was recorded in 11% of patients, with hemorrhage (9%), urinary retention (4%), and scrotal or subcutaneous emphysema (3%) being the most common. The mean follow up was 14.4 months (SD 17.4). Local recurrence occurred in 6%, and distant organ metastasis was noted in 2%. Mean time to local recurrence for malignancy was 16.9 months (SD 13.2). Cumulative DFS for patients with rectal adenocarcinoma was 96%, 93%, and 84% at 1-, 2-, and 3-years. CONCLUSIONS: For carefully selected patients, TAMIS for local excision of rectal neoplasia is a valid option with low morbidity that maintains the advantages of organ preservation.

Impact of Tumor Deposits on Oncologic Outcomes in Stage III Colon Cancer.

BACKGROUND: The prognosis of tumor deposits in stage III colon adenocarcinoma is poorly described. OBJECTIVE: The purpose of this study was to determine the impact of tumor deposits on oncologic outcomes in patients with stage III colon cancer. DESIGN: This was a multicenter retrospective cohort study. SETTINGS: The 2010 to 2014 National Cancer Database was queried for patients with resected stage III colon adenocarcinoma on final pathology. PATIENTS: Patients were divided into 3 groups: lymph nodes+tumor deposits-, lymph nodes+tumor deposits+, and lymph nodes-tumor deposits+. MAIN OUTCOME MEASURES: The main outcome was 5-year overall survival. RESULTS: Of 74,577 patients, there were 55,800 patients with lymph nodes+tumor deposits-, 13,740 patients with lymph nodes+tumor deposits+, and 5037 patients with lymph nodes-tumor deposits+. The groups had similar patient and facility characteristics, but patients with lymph nodes+tumor deposits+ had more advanced tumor characteristics. Patients with lymph nodes-tumor deposits+ were less likely to receive adjuvant systemic therapy (52% vs 74% lymph nodes+tumor deposits- and 75% lymph nodes+tumor deposits+, p < 0.001) and had a longer delay to initiation of adjuvant treatment (>8 weeks; 43% vs 33% lymph nodes+tumor deposits- and 33% lymph nodes+tumor deposits+, p < 0.001). Patients with lymph nodes+tumor deposits+ had the lowest 5-year overall survival (46.0% vs 63.4% lymph nodes+tumor deposits- vs 61.9% lymph nodes-tumor deposits+, p < 0.001). On multivariate analysis, patients with lymph nodes-tumor deposits+ had similar 5-year overall survival compared with patients with lymph nodes+tumor deposits- with ≤3 positive lymph nodes (HR, 0.93; 95% CI, 0.87-1.01). Patients with lymph nodes+tumor deposits+ had worse prognosis regardless of the number of involved lymph nodes (≤3 +lymph nodes: HR, 1.37; 95% CI, 1.28-1.47 and ≥4 +lymph nodes: HR, 1.30; 95% CI, 1.22-1.38). Of those not receiving adjuvant treatment, patients with lymph nodes-tumor deposits+ were younger and had more adverse tumor features than lymph node+ disease. Lymph nodes-tumor deposits+ was independently associated with less delivery of adjuvant systemic therapy (OR, 0.81; 95% CI, 0.80-0.82). LIMITATIONS: This study was limited by its retrospective analysis of a prospective database. CONCLUSIONS: The prognosis of patients with N1c disease is similar to nodal involvement without tumor deposits, yet these patients were less likely to receive adjuvant systemic therapy. Improvement in the delivery of appropriate care in these patients may increase survival and should be a target of future quality initiatives. See Video Abstract at http://links.lww.com/DCR/A666.

Establishing the learning curve of transanal minimally invasive surgery for local excision of rectal neoplasms.

INTRODUCTION: Transanal minimally invasive surgery (TAMIS) is an endoscopic operating platform for local excision of rectal neoplasms. However, it may be technically demanding, and its learning curve has yet to be adequately defined. The objective of this study was to determine the number of TAMIS procedures for the local excision of rectal neoplasm required to reach proficiency. METHODS AND PROCEDURES: All TAMIS cases performed from 07/2009 to 12/2016 at a single high-volume tertiary care institution for local excision of benign and malignant rectal neoplasia were identified from a prospective database. A cumulative summation (CUSUM) analysis was performed to determine the number of cases required to reach proficiency. The main proficiency outcome was rate of margin positivity (R1 resection). The acceptable and unacceptable R1 rates were defined as the R1 rate of transanal endoscopic microsurgery (TEM-10%) and traditional transanal excision (TAE-26%), which was obtained from previously published meta-analyses. Comparisons of patient, tumor, and operative characteristics before and after TAMIS proficiency were performed. RESULTS: A total of 254 TAMIS procedures were included in this study. The overall R1 resection rate was 7%. The indication for TAMIS was malignancy in 57%. CUSUM analysis reported that TAMIS reached an acceptable R1 rate between 14 and 24 cases. Moving average plots also showed that the mean operative times stabilized by proficiency gain. The mean lesion size was larger after proficiency gain (3.0 cm (SD 1.5) vs. 2.3 cm (SD 1.3), p = 0.008). All other patient, tumor, and operative characteristics were similar before and after proficiency gain. CONCLUSIONS: TAMIS for local excision of rectal neoplasms is a complex procedure that requires a minimum of 14-24 cases to reach an acceptable R1 resection rate and lower operative duration.

Uptake of Transanal Total Mesorectal Excision in North America: Initial Assessment of a Structured Training Program and the Experience of Delegate Surgeons.

BACKGROUND: Transanal total mesorectal excision is a new approach to curative-intent rectal cancer surgery. Training and surgeon experience with this approach has not been assessed previously in America. OBJECTIVE: The purpose of this study was to characterize a structured training program and to determine the experience of delegate surgeons. DESIGN: Data were assimilated from an anonymous, online survey delivered to attendees on course completion. Data on surgeon performance during hands-on cadaveric dissection were collected prospectively. SETTINGS: This study was conducted at a single tertiary colorectal surgery referral center, and cadaveric hands-on training was conducted at a specialized surgeon education center. MAIN OUTCOME MEASURES: The main outcome measurement was the use of the course and surgeon experience posttraining. RESULTS: During a 12-month period, eight 2-day transanal total mesorectal excision courses were conducted. Eighty-one colorectal surgeons successfully completed the course. During cadaveric dissection, 71% achieved a complete (Quirke 3) specimen; 26% were near complete (Quirke 2), and 3% were incomplete (Quirke 1). A total of 9.1% demonstrated dissection in the incorrect plane, whereas 4.5% created major injury to the rectum or surrounding structures, excluding the prostate. Thirty eight (46.9%) of 81 surgeon delegates responded to an online survey. Of survey respondents, 94.6% believed training should be required before performing transanal total mesorectal excision. Posttraining, 94.3% of surgeon delegates planned to use transanal total mesorectal excision for distal-third rectal cancers, 74.3% for middle-third cancers, and 8.6% for proximal-third cancers. The most significant complication reported was urethral injury; 5 were reported by the subset of survey respondents who had performed this operation postcourse. LIMITATIONS: The study was limited by inherent reporting bias, including observer and recall biases. CONCLUSIONS: Although this structured training program for transanal total mesorectal excision was found to be useful by the majority of respondents, the risk of iatrogenic injury after training remains high, suggesting that this training pedagogy alone is insufficient. See Video Abstract at http://links.lww.com/DCR/A335.

Stereotactic navigation for TAMIS-TME: opening the gateway to frameless, image-guided abdominal and pelvic surgery.

BACKGROUND: Frameless stereotaxy is an established method for real-time image-guided surgical navigation in neurological surgery. Though this is capable of providing sub-millimeter accuracy, it has not been used by other surgical specialists. METHODS AND PROCEDURE: A patient with locally advanced, distal rectal cancer and tumor abutting the prostate was selected for transanal TME using TAMIS, with intra-operative CT-guided navigation to ensure an R0 resection. RESULTS: The use of stereotactic TAMIS-TME was successfully performed with an accuracy of ±4 mm. The surgical specimen revealed an R0 resection, and this new approach aided in achieving adequate resection margins. CONCLUSION: This is the first report of the use of frameless stereotactic navigation beyond the scope of neurosurgery. Stereotactic navigation for transanal total mesorectal excision is shown to be feasible. Stereotactic navigation may potentially be applied toward other pelvic and fixed abdominal organs, thereby opening the gateway for a broader use by the general surgeon.

Transanal Minimally Invasive Surgery.

Transanal minimally invasive surgery (TAMIS) was first described in 2010 as a crossover between single-incision laparoscopic surgery and transanal endoscopic microsurgery (TEM) to allow access to the proximal and mid-rectum for resection of benign and early-stage malignant rectal lesions. The TAMIS technique can also be used for noncurative intent surgery of more advanced lesions in patients who are not candidates for radical surgery. Proper workup and staging should be done before surgical decision-making. In addition to the TAMIS port, instrumentation and set up include readily available equipment found in most operating suites. TAMIS has proven its usefulness in a wide range of applications outside of local excision, including repair of rectourethral fistula, removal of rectal foreign body, control of rectal hemorrhage, and as an adjunct in total mesorectal excision for rectal cancer. TAMIS is an easily accessible, technically feasible, and cost-effective alternative to TEM.

Sphincter-sparing surgery for adenocarcinoma of the distal 3 cm of the true rectum: results after neoadjuvant therapy and minimally invasive radical surgery or local excision.

BACKGROUND: Ideal treatment of rectal cancer includes controlling the cancer; minimizing trauma, morbidity, and mortality; and avoiding a colostomy with preservation of adequate function. These goals become more challenging the further distal in the rectum the cancer is located. We sought to determine whether minimally invasive sphincter-preservation surgery (SPS) can accomplish good cancer control, maintaining sphincter function with minimal morbidity and mortality in rectal cancers of the distal 3 cm after receiving neoadjuvant chemoradiotherapy. METHODS: We retrospectively reviewed a prospectively maintained rectal cancer database of a single colorectal surgeon to identify all patients with cancers of the distal 3 cm undergoing SPS via a laparoscopic total mesorectal excision or transanal endoscopic microsurgery (TEM). All patients received neoadjuvant chemoradiotherapy. Patient data, including demographics, initial tumor characteristics, staging, radiation dose, perioperative morbidity and mortality, and local recurrence (LR) and survival, were analyzed. RESULTS: A total of 161 patients (108 men) underwent SPS via 3 techniques: transanal abdominal transanal proctosigmoidectomy (TATA, n = 106), TEM (n = 49), or ultralow anterior resection (LAR, n = 6). Average age was 62 years (range 22-90 years). The mean levels in rectum from the anorectal ring were as follows: TATA, 1.3 cm (range -1.0 to 3.0 cm), TEM, 1.5 cm (range -0.5 to -3.0 cm), and LAR, 2.9 cm (range 2.5-3.0 cm) (p > 0.05). Preoperative T stage was as follows: T3, n = 108 (TATA 83, TEM 20, LAR 5), T2, n = 48 (TATA 22, TEM 25, LAR 1), T1, n = 3 (TATA 1, TEM 2), and T4, n = 2 (both TEM). All patients received concomitant 5-fluorouracil-based chemotherapy and radiotherapy (mean, 5300 cGy; range 3,000-7,295 cGy). The mean estimated blood loss was 376 ml (range 10-3,600 ml). There were no mortalities. Morbidity rates were as follows: LAR, 0; TATA, 13.2%; and TEM, 32 % (wound disruption: major, 10%; minor, 16%). Pathologic staging was as follows: ypCR: uT2, 34%, and uT3, 19%. Overall LR was 3.7%. By procedure, the follow-up, LR, and KM5YAS, respectively, were: TATA, 37.9 months, 3 and 95%; TEM, 36.3 months, 6 and 88%; and LAR, 63.1 months, 0 and 75% (p > 0.05). CONCLUSIONS: This study demonstrates positive oncologic outcomes, low LR rates, and high KM5YS after minimally invasive SPS. A colostomy-free lifestyle and cancer control make the minimally invasive surgical approach an excellent treatment option for complex distal rectal cancers.

Large rectal diverticulum in the setting of pelvic organ prolapse treated with robotic ventral mesh rectopexy: a case report.

Background: Rectal diverticula are a very rare occurrence compared to diverticula of the colon. They are reported to account for only 0.08% of all diverticulosis. Diverticula of the rectum can be caused by congenital or acquired factors. The majority are asymptomatic, diagnosed incidentally, and require no treatment. The low incidence of rectal diverticulosis may be attributed to the unique anatomical structure and physiological environment of the rectum. However, complications can arise and may necessitate surgical or endoscopic treatment. Case Description: We report the case of a 72-year-old female with a history of diabetes mellitus, hyperlipidemia, and hypothyroidism who presented to the colorectal surgery clinic with symptoms of constipation of nearly a 50-year duration. The patient underwent an anorectal exam under anesthesia which revealed a 3 cm defect in the left levator muscles with herniated rectal wall. A large left lateral rectal diverticulum was diagnosed during the work-up for pelvic organ prolapse on defecography. She underwent robotic assisted ventral mesh rectopexy and recovered uneventfully. After 1 year of follow-up, the patient is asymptomatic, and the control colonoscopy shows no signs of the rectal diverticulum. Conclusions: Rectal diverticula can present in the setting of pelvic organ prolapse and can be safely managed with ventral mesh rectopexy.

Evolving the management of acute perioperative pain towards opioid free protocols: a narrative review.

Objective: Identification of pain as the fifth vital sign has resulted in over-prescription and overuse of opioids in the US, with addiction reaching epidemic proportions. In Europe, and more recently in the US, a shift has occurred with the global adoption of multimodal analgesia (MMA), which seeks to minimize perioperative opioid use. Improved functional outcomes and reduced healthcare utilization costs have been demonstrated with MMA, but wide scale use of opioids in pain management protocols continues. As a next step in the pain management evolution, opioid-free analgesia (OFA) MMA strategies have emerged as feasible in many surgical settings.Methods: Articles were limited to clinical studies and meta-analyses focusing on comparisons between opioid-intensive and opioid-free/opioid-sparing strategies published in English.Results: In this review, elimination or substantial reduction in opioid use with OFA strategies for perioperative acute pain are discussed, with an emphasis on improved pain control and patient satisfaction. Improved functional outcomes and patient recovery, as well as reduced healthcare utilization costs, are also discussed, along with challenges facing the implementation of such strategies.Conclusions: Effective MMA strategies have paved the way for OFA approaches to postoperative pain management, with goals to reduce opioid prescriptions, improve patient recovery, and reduce overall healthcare resource utilization and costs. However, institution-wide deployment and adoption of OFA is still in early stages and will require personalization and better management of patient expectations.

Examining the relationship between lymph node harvest and survival in patients undergoing colectomy for colon adenocarcinoma.

BACKGROUND: Current standards for lymph node harvest in colorectal cancer surgery may be inadequate. Higher lymph node yield may improve survival, but the number of lymph nodes needed to optimize survival is unknown. The objective of this study was to examine the relationship between lymph node yield and overall survival in patients undergoing colectomy for nonmetastatic colon adenocarcinoma. METHODS: The 2010 to 2014 National Cancer Database was queried for patients undergoing colectomy for nonmetastatic colon adenocarcinoma. Adjusted restricted cubic splines were used to model the nonlinear relationship between lymph node harvest and overall survival. Cox proportional hazard determined independent predictors of overall survival. RESULTS: A total of 261,423 patients were included. Restricted cubic splines demonstrated that the adjusted improvements in overall survival stabilized after 24 nodes. Patients were divided into: <12, 12 to 23, and ≥24 nodes. On survival analysis, patients with ≥24 nodes had better survival across all N stages compared to other groups (P < .001). Lymph node harvest ≥24 nodes was independently associated with improved overall survival compared to 12 to 23 nodes (hazard ratio 0.82; 95% confidence interval, 0.80-0.85). CONCLUSION: Lymph node harvest ≥24 nodes is associated with improved survival in colorectal cancer patients. These data may provide indirect evidence for a more extensive lymphadenectomy for colon cancer.

Impact of residual nodal involvement after complete tumor response in patients undergoing neoadjuvant (chemo)radiotherapy for rectal cancer.

BACKGROUND: The management of patients with a complete clinical response after neoadjuvant therapy for rectal adenocarcinoma is controversial. Those who advocate for resection point out the inaccuracy of N-staging with current imaging modalities. The objective of this study is to determine the impact of residual nodal involvement after complete tumor regression after neoadjuvant (chemo)radiotherapy. METHODS: The 2004 to 2014 National Cancer Database was queried for patients undergoing proctectomy for nonmetastatic rectal adenocarcinoma who had received neoadjuvant (chemo)radiotherapy and with ypT0 on final pathology. Patients were grouped based on pathologic nodal stage: ypT0N- and ypT0N+. The main outcome was 5-year overall survival. RESULTS: There were 5,156 patients with ypT0N- and 527 with ypT0N+. Mean lymph node harvest was similar (ypT0N- 12.2 nodes [standard deviation 9.1] vs ypT0N+ 11.6 nodes [standard deviation 10.3]; P = .086). Patients with ypT0N+ were more likely to have had clinically involved nodes (P < .001) and earlier clinical T-stage (P = .002). Overall survival at 5 years was less for patients with ypT0N+ (80% vs 86%, log-rank P = .014). ypT0N+ was independently associated with worse overall survival (hazard ratio 1.74, 95% confidence interval 1.33-2.28). CONCLUSION: Residual nodal involvement despite complete tumor regression was associated with worse 5-year overall survival compared to complete pathologic response. Additional therapy should be considered in the presence of complete clinical tumor regression after neoadjuvant (chemo)radiotherapy.

Lower survival after right-sided versus left-sided colon cancers: Is an extended lymphadenectomy the answer?

INTRODUCTION: Tumour location may affect oncologic outcomes for colon adenocarcinoma due to different levels of vascular ligation and nodal harvest, but the data are equivocal. The objective of this study is to determine the effect of tumor location and lymph node yield on overall survival(OS) in stage I-III colon adenocarcinoma. METHODS: The 2004-2014 National Cancer Database was queried for colectomies for non-metastatic colon adenocarcinoma, excluding transverse colon and rectal cancer. Patients were grouped based on left/right tumor location. Main outcome measure was 5-year OS. Propensity score matching created balanced cohorts. Multilevel survival analysis determined the independent effect of tumor location and nodal harvest on OS. RESULTS: There were 504,958 patients (273,198 right; 231,760 left) in the entire cohort: 26.4% stage-I, 37.3% stage-II, and 36.3% stage-III (equal distribution left/right). After 1:1 matching(n = 297,080), right cancers were associated with worse 5-year overall survival for stage-II (66% vs. 70%, p < 0.001) and -III (56% vs. 60%, p < 0.001) despite similar nodal harvest and proportion receiving systemic therapy. On multivariate analysis, right-sided cancers (HR 1.12, 95%CI 1.06-1.19) had worse OS, independent of stage and nodal harvest. Nodal harvest ≥22 nodes had the highest OS (HR 0.71, 95%CI 0.68-0.75). There was an interaction between right-sided cancer and >22 lymph node harvest towards increased survival (HR 0.86, 95%CI 0.80-0.92). CONCLUSIONS: Right-sided cancers are associated with worse oncologic outcomes compared to left-sided tumors but a higher lymph node yield improves survival. These data provide indirect evidence for a higher lymphatic harvest to improve survival.

Chemoradiation and Local Excision for T2N0 Rectal Cancer Offers Equivalent Overall Survival Compared to Standard Resection: a National Cancer Database Analysis.

BACKGROUND: Local excision (LE) alone is associated with worse survival compared to radical surgery (RS) for T2 rectal cancer, but LE with additional chemoradiation (CRT) may improve outcomes. The objective of this study was to compare combined CRT and LE versus RS for T2 rectal cancer. METHODS: The 2004-2014 National Cancer Database was queried for patients with T2N0M0 rectal cancer undergoing LE with neoadjuvant(NA-CRT + LE) or adjuvant(LE + Adj-CRT) CRT, or RS. The main outcome was 5-year overall survival (OS). Cox proportional hazards was used to determine the independent effect of treatment on OS. RESULTS: A total of 4822 patients were included (4367 RS, 242 CRT + LE, 213 LE + Adj-CRT). Mean follow-up was 48.6 (SD28.5) months. There were no differences in patient characteristics, but more high-risk features in the LE + Adj-CRT group. There were no differences in 90-day mortality. Five-year OS was similar (RS 77.4% vs. CRT + LE 76.1% vs. LE + Adj-CRT 79.7%, p = 0.786). Older age, male gender, and higher Charlson score were independently associated with worse OS, whereas treatment type was not. If 90-day mortality was excluded, LE + Adj-CRT was independently associated with worse OS compared to RS. CONCLUSIONS: CRT with LE for T2N0M0 rectal cancer was not associated with worse OS compared to RS, and may be a viable treatment modality.

Low-density lipoprotein cholesterol goal attainment among high-risk patients: Does a combined intervention targeting patients and providers work?

BACKGROUND: Physicians are aware of the National Cholesterol Education Program guidelines; however, most patients fail to attain cholesterol goals. OBJECTIVE: To determine whether a combined program of patient education and provider awareness could improve the National Cholesterol Education Program goal attainment among patients at high risk for cardiovascular events. METHODS: One hundred seven high-risk patients with cardiovascular disease were educated in a single 15-minute session regarding their cholesterol levels, risk factors, and medication adherence. Those with scores of 2 or lower on the Morisky questionnaire were classified as low-adherence patients, and those with scores of 3 or higher were classified as high-adherence patients. Seven physicians were provided this information and were requested to evaluate the dyslipidemia management of these patients. Lipid levels were reevaluated 8 to 12 weeks after the intervention. RESULTS: At the start of the study, 38 (35.5%) of the 107 patients were at target low-density lipoprotein cholesterol (LDL-C) levels, and 64 of the 107 patients (59.8%) were at target levels after the intervention. High-adherence patients decreased their LDL-C levels from a mean of 118.6 mg/dL (3.07 mmol/L) to 98.6 mg/dL (2.55 mmol/L); low-adherence patients increased their LDL-C levels after the intervention from 134.5 mg/dL (3.48 mmol/L) to 142.1 mg/dL (3.68 mmol/L). A comparison between the LDL-C goal achievers vs nonachievers revealed a significant difference in adherence (P = .001). Among the goal achievers, significant decreases in preintervention vs postintervention total cholesterol levels (P = .001) and LDL-C levels (P = .001) were also noted. CONCLUSION: This study demonstrates that an intervention simultaneously targeting patients and providers is successful in improving goal attainment among high-risk patients.