Functional Outcomes After Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: Results from the Phase II North American Multicenter Prospective Observational Trial.

OBJECTIVE: To investigate fecal incontinence and defecatory, urinary, and sexual functional outcomes after taTME. SUMMARY BACKGROUND DATA: Proctectomy for rectal cancer may result in alterations in defecatory, urinary, and sexual function that persist beyond 12 months. The recent multicenter Phase II taTME trial demonstrated the safety of taTME in patients with stage I-III tumors. METHODS: Prospectively registered self-reported questionnaires were collected from 100 taTME patients. Fecal continence (FIQL, Wexner), defecatory function (COREFO), urinary function (IPSS), and sexual function (FSFI-female, IIEF-male) were assessed preoperatively (PQ), 3-4 months post-ileostomy closure (FQ1), and 12-18 months post-taTME (FQ2). RESULTS: Among 83 patients who responded at all three time points, FIQL, Wexner, and COREFO significantly worsened post-ileostomy closure. Between FQ1 and FQ2, FIQL lifestyle and coping, Wexner, and COREFO incontinence, social impact, frequency, and need for medication significantly improved, while FIQL depression and embarrassment did not change. IPSS did not change relative to preoperative scores. For females, FSFI declined for desire, orgasm, and satisfaction between PQ and FQ1, and did not improve between FQ1 and FQ2. In males, IIEF declined with no change between FQ1 and FQ2. CONCLUSIONS: Although taTME resulted in initial decline in defecatory function and fecal continence, most functional domains improved by 12 months after ileostomy closure, without returning to preoperative status. Urinary function was preserved while sexual function declined without improvement by 18 months post-taTME. Our results address patient expectations and inform shared decision-making regarding taTME.

Oncologic outcomes following transanal total mesorectal excision: the United States experience.

AIM: The benefits and short-term outcomes of transanal total mesorectal excision (taTME) for rectal cancer have been demonstrated previously, but questions remain regarding the oncologic outcomes following this challenging procedure. The purpose of this study was to analyze the oncologic outcomes following taTME at high-volume centers in the USA. METHODS: This was a multicenter, retrospective observational study of 8 tertiary care centers. All consecutive taTME cases for primary rectal cancer performed between 2011 and 2020 were included. Clinical, histopathologic, and oncologic data were analyzed. Primary endpoints were rate of local recurrence, distal recurrence, 3-year disease recurrence, and 3-year overall survival. Secondary endpoints included perioperative complications and TME specimen quality. RESULTS: A total of 391 patients were included in the study. The median age was 57 years (IQR: 49, 66), 68% of patients were male, and the median BMI was 27.4 (IQR: 24.1, 31.0). TME specimen was complete or near complete in 94.5% of cases and the rates of positive circumferential radial margin and distal resection margin were 2.0% and 0.3%, respectively. Median follow-up time was 30.7 months as calculated using reverse-KM estimator (CI 28.1-33.8) and there were 9 cases (2.5%) of local recurrence not accounting for competing risk. The 3-year estimated rate of disease recurrence was 19% (CI 15-25%) and the 3-year estimated overall survival was 90% (CI 87-94%). CONCLUSION: This large multicenter study confirms the oncologic safety and perioperative benefits of taTME for rectal cancer when performed by experienced surgeons at experienced referral centers.

SafeHeal Colovac Colorectal Anastomosis Protection Device evaluation (SAFE-2) pivotal study: an international randomized controlled study to evaluate the safety and effectiveness of the Colovac Colorectal Anastomosis Protection Device.

AIM: Although proximal faecal diversion is standard of care to protect patients with high-risk colorectal anastomoses against septic complications of anastomotic leakage, it is associated with significant morbidity. The Colovac device (CD) is an intraluminal bypass device intended to avoid stoma creation in patients undergoing low anterior resection. A preliminary study (SAFE-1) completed in three European centres demonstrated 100% protection of colorectal anastomoses in 15 patients, as evidenced by the absence of faeces below the CD. This phase III trial (SAFE-2) aims to evaluate the safety and effectiveness of the CD in a larger cohort of patients undergoing curative rectal cancer resection. METHODS: SAFE-2 is a pivotal, multicentre, prospective, open-label, randomized, controlled trial. Patients will be randomized in a 1:1 ratio to either the CD arm or the diverting loop ileostomy arm, with a recruitment target of 342 patients. The co-primary endpoints are the occurrence of major postoperative complications within 12 months of index surgery and the effectiveness of the CD in reducing stoma creation rates. Data regarding quality of life and patient's acceptance and tolerance of the device will be collected. DISCUSSION: SAFE-2 is a multicentre randomized, control trial assessing the efficacy and the safety of the CD in protecting low colorectal anastomoses created during oncological resection relative to standard diverting loop ileostomy. TRIAL REGISTRATION: NCT05010850.

Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.

BACKGROUND: Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765). METHODS: 100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications. RESULTS: Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003). CONCLUSION: When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.

Discordance in Total Mesorectal Excision Specimen Grading in a Prospective Phase 2 Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of Our Resections?

OBJECTIVES: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase 2 trial of transanal TME. BACKGROUND: Grading of TME specimens is based on the macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described. METHODS: A phase 2 prospective transanal TME trial was conducted from 2017 to 2022 across 11 North American centers with TME quality as the primary study endpoint. QC measures included (1) training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance before trial reporting. Cohen Kappa statistic was used to assess agreement in grading. RESULTS: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ = 0.35; 95% CI: 0.10-0.61; P < 0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases, respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre versus postreconciliation rates of complete or NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC-NC; N = 1) or major downgrade (NC/C-IC, N = 4) in 5 cases overall (5%). CONCLUSIONS: A 14% rate of major discordance was observed in TME grading between the site and central reviewers. The resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through a central review of TME photographs and reconciliation of major discordances is strongly recommended.

Same-Day Discharge After Minimally Invasive Colectomy.

This article describes elements of a same-day discharge program for minimally invasive colectomy as an evolution of enhanced recovery pathways for colorectal surgery.

Same day discharge following elective, minimally invasive, colorectal surgery : A review of enhanced recovery protocols and early outcomes by the SAGES Colorectal Surgical Committee with recommendations regarding patient selection, remote monitoring, and successful implementation.

BACKGROUND: As enhanced recovery programs (ERPs) have continued to evolve, the length of hospitalization (LOS) following elective minimally invasive colorectal surgery has continued to decline. Further refinements in multimodal perioperative pain management strategies have resulted in reduced opioid consumption. The interest in ambulatory colectomy has dramatically accelerated during the COVID-19 pandemic. Severe restrictions in hospital capacity and fear of COVID transmission forced surgical teams to rethink strategies to further reduce length of inpatient stay. METHODS: Members of the SAGES Colorectal Surgery Committee began reviewing the emergence of SDD protocols and early publications for SDD in 2019. The authors met at regular intervals during 2020-2022 period reviewing SDD protocols, safe patient selection criteria, surrogates for postoperative monitoring, and early outcomes. RESULTS: Early experience with SDD protocols for elective, minimally invasive colorectal surgery suggests that SDD is feasible and safe in well-selected patients and procedures. SDD protocols are associated with reduced opioid use and prescribing. Patient perception and experience with SDD is favourable. For early adopters, SDD has been the natural evolution of well-developed ERPs. Like all ERPs, SDD begins in the office setting, identifying the correct patient and procedure, aligning goals and objectives, and the perioperative education of the patient and their supporting significant others. A thorough discussion with the patient regarding expected activity levels, oral intake, and pain control post operatively lays the foundation for a successful application of SDD programs. These observations may not apply to all patient populations, institutions, practice types, or within the scope of an existing ERP. However, if the underlying principles of SDD can be incorporated into an existing institutional ERP, it may further reduce the incidence of post operative ileus, prolonged LOS, and improve the effectiveness of oral analgesia for postoperative pain management and reduced opioid use and prescribing. CONCLUSIONS: The SAGES Colorectal Surgery Committee has performed a comprehensive review of the early experience with SDD. This manuscript summarizes SDD early results and considerations for safe and stepwise implementation of SDD with a specific focus on ERP evolution, patient selection, remote monitoring, and other relevant considerations based on hospital settings and surgical practices.

Reduced Opioid Use and Prescribing in a Same Day Discharge Pilot Enhanced Recovery Program for Elective Minimally Invasive Colorectal Surgical Procedures During the COVID-19 Pandemic.

PURPOSE: Enhanced recovery pathways (ERPs) are associated with reduced complications and length of stay. The validation of the I-FEED scoring system, advances in perioperative anesthesia, multimodal analgesia, and telehealth remote monitoring have resulted in further evolution of ERPs setting the stage for same day discharge (SDD). Pioneers and early adopters have demonstrated the safety and feasibility of SDD programs. The aim of this study is to evaluate the impact of a pilot SDD ERP on patient self-reported pain scoring and narcotic usage. METHODS: A quality improvement pilot program was conducted to assess the impact of a SDD ERP on post-operative pain score reporting and opioid use in healthy patients undergoing elective colorectal surgery as an alternative to post-operative hospitalization during the COVID-19 pandemic (May 2020-December 2021). Patients were monitored remotely with daily telephone visits on POD 1-7 assessing the following variables: I-FEED score, pain score, pain management, bowel function, dietary advancement, any complications, and/or re-admissions. RESULTS: Thirty-seven patients met the highly selective eligibility criteria for "healthy patient, healthy anastomosis." SDD occurred in 70%. The remaining 30% were discharged on POD 1. Mean total narcotic usage was 5.2 tablets of 5 mg oxycodone despite relatively high reported pain scores. CONCLUSIONS: In our initial experience, SDD is associated with significantly lower patient narcotic utilization for postoperative pain management than hypothesized. This pilot SDD program resulted in a change in clinical practice with reduction of prescribed discharge oxycodone 5 mg quantity from #40 to #10 tablets.

The SAGES MASTERS program presents: the 10 seminal articles for the Laparoscopic Right Colectomy Pathway.

BACKGROUND: As one of the 12 clinical pathways of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Masters Program, the Colorectal Pathway intends to deliver didactic content organized along 3 levels of performance (competency, proficiency and mastery) each represented by an anchoring procedure (laparoscopic right colectomy, laparoscopic left/sigmoid colectomy, and intracorporeal anastomosis during minimally invasive (MIS) ileocecal or right colon resection). In this article, the SAGES Colorectal Task Force presents focused summaries of the top 10 seminal articles selected for laparoscopic right colectomy which surgeons should be familiar with. METHODS: Using a systematic literature search of Web of Science, the most cited articles on laparoscopic right colectomy were identified, reviewed, and ranked by the SAGES Colorectal Task Force and invited subject experts. Additional articles not identified in the literature search were included if deemed impactful by expert consensus. The top 10 ranked articles were then summarized, with emphasis on relevance and impact in the field, findings, strengths and limitations, and conclusions. RESULTS: The top 10 seminal articles selected for the laparoscopic right colectomy anchoring procedure include articles on surgical techniques for benign and malignant disease, with anatomical and video illustrations, comparative outcomes of laparoscopic vs open colectomy, variations in technique with impact on clinical outcomes, and assessment of the learning curve. CONCLUSIONS: The top 10 seminal articles selected for laparoscopic right colectomy illustrate the diversity both in content and format of the educational curriculum of the SAGES Masters Program to support practicing surgeon progression to mastery within the Colorectal Pathway.

North American multicentre evaluation of a same-day discharge protocol for minimally invasive colorectal surgery using mHealth or telephone remote post-discharge monitoring.

BACKGROUND: Same-day discharge (SDD) after colectomy is feasible but requires effective post-discharge remote follow-up. Previous studies have used in-person home visits or a mobile health (mHealth) phone app, but the use of simple telephone calls for remote follow-up has not yet been studied. Therefore, the objective of this study was to compare outcomes after SDD for minimally invasive colectomy using mHealth or telephone remote post-discharge follow-up. METHODS: A prospective cohort study was undertaken at two university-affiliated colorectal referral institutions from 02/2020 to 05/2021. Adult patients without significant comorbidities undergoing elective minimally invasive colectomy. Patients were discharged on the day of surgery based on set criteria. Post-discharge remote follow-up was performed using a mHealth app at site 1 and scheduled telephone calls at site 2 up to postoperative day (POD) 7. The main outcome for this study was the success rate of SDD, defined as discharge on POD0 without emergency department (ED) visit or readmission within the first 3 days. RESULTS: A total of 105 patients were recruited (site 1, n = 70; site 2, n = 35). Overall, 75% of patients were discharged on POD0 (site 1 81% vs. site 2 63%, p = 0.038), of which only two patients required an ED visit within the first 3 days, leading to an overall success rate of 73% (site 1 80% vs. site 2 60%, p = 0.029). The incidence of 30-day complications (16% vs. 20%, p = 0.583), ED visits (11% vs. 11%, p = 1.00), and readmissions (9% vs. 14%, p = 0.367) were similar between the two sites. There was only one patient at each study site that went to the ED without instructions through remote follow-up. CONCLUSIONS: A high proportion of patients planned for SDD were discharged on POD0 with few patients requiring an early unplanned ED visit. These results were similar with an mHealth app or telephone calls for post-discharge remote follow-ups, suggesting that SDD is feasible regardless of the method of post-discharge remote follow-up.

Metabolic Risk Factors Associated with Early-Onset Colorectal Adenocarcinoma: A Case-Control Study at Kaiser Permanente Southern California.

BACKGROUND: The incidence of early-onset colorectal cancer (eoCRC) diagnosed among individuals under age 50 has been rising. However, risk factors for eoCRC are unclear. We investigated whether metabolic abnormalities are risk factors for eoCRC adenocarcinoma. METHODS: Invasive colorectal adenocarcinoma cases diagnosed between ages 15 and 49 from 2008 to 2018 at Kaiser Permanente Southern California (KPSC) were identified. Those with a history of inflammatory bowel disease were excluded. Noncancer controls were selected 5:1 for each case matched by age, sex, and length of membership prior to index date. Data were collected from KSPC's electronic medical records. The exposures of interest included obesity, type II diabetes, hypertension, and dyslipidemia, assessed from ≥1 year prior to eoCRC diagnosis/index date. Conditional logistic regressions were used to evaluate the associations between these metabolic risk factors and risk of eoCRC adenocarcinoma, adjusting for race/ethnicity, smoking, family history, neighborhood socioeconomic status, and health care utilization. RESULTS: A total of 1,032 cases and 5,128 controls were included. Risk of colorectal adenocarcinoma was significantly associated with obesity [odds ratio (OR) = 1.41; 95% confidence interval (CI), 1.15-1.74], but not diabetes, hypertension or dyslipidemia. In analysis stratified by tumor location, obesity was significantly associated with risk of colon adenocarcinoma OR = 1.56 (1.17-2.07), but its association with rectal adenocarcinoma was less clear OR = 1.19 (0.85-1.68). No significant interaction was detected between obesity and age (≥40 vs. <40), and obesity and sex. CONCLUSIONS: Obesity was associated with risk for eoCRC adenocarcinoma. IMPACT: This finding could help inform early-onset colorectal adenocarcinoma screening and prevention recommendations.See related commentary by Hayes, p. 1775.

Perfusion Assessment in Left-Sided/Low Anterior Resection (PILLAR III): A Randomized, Controlled, Parallel, Multicenter Study Assessing Perfusion Outcomes With PINPOINT Near-Infrared Fluorescence Imaging in Low Anterior Resection.

BACKGROUND: Indocyanine green fluoroscopy has been shown to improve anastomotic leak rates in early phase trials. OBJECTIVE: We hypothesized that the use of fluoroscopy to ensure anastomotic perfusion may decrease anastomotic leak after low anterior resection. DESIGN: We performed a 1:1 randomized controlled parallel study. Recruitment of 450 to 1000 patients was planned over 2 years. SETTINGS: This was a multicenter trial. PATIENTS: Included patients were those undergoing resection defined as anastomosis within 10 cm of the anal verge. INTERVENTION: Patients underwent standard evaluation of tissue perfusion versus standard in conjunction with perfusion evaluation using indocyanine green fluoroscopy. MAIN OUTCOME MEASURES: Primary outcome was anastomotic leak, with secondary outcomes of perfusion assessment and the rate of postoperative abscess requiring intervention. RESULTS: This study was concluded early because of decreasing accrual rates. A total of 25 centers recruited 347 patients, of whom 178 were randomly assigned to perfusion and 169 to standard. The groups had comparable tumor-specific and patient-specific demographics. Neoadjuvant chemoradiation was performed in 63.5% of perfusion and 65.7% of standard (p > 0.05). Mean level of anastomosis was 5.2 ± 3.1 cm in perfusion compared with 5.2 ± 3.3 cm in standard (p > 0.05). Sufficient visualization of perfusion was reported in 95.4% of patients in the perfusion group. Postoperative abscess requiring surgical management was reported in 5.7% of perfusion and 4.2% of standard (p = 0.75). Anastomotic leak was reported in 9.0% of perfusion compared with 9.6% of standard (p = 0.37). On multivariate regression analysis, there was no difference in anastomotic leak rates between perfusion and standard (OR = 0.845 (95% CI, 0.375-1.905); p = 0.34). LIMITATIONS: The predetermined sample size to adequately reduce the risk of type II error was not achieved. CONCLUSIONS: Successful visualization of perfusion can be achieved with indocyanine green fluoroscopy. However, no difference in anastomotic leak rates was observed between patients who underwent perfusion assessment versus standard surgical technique. In experienced hands, the addition of routine indocyanine green fluoroscopy to standard practice adds no evident clinical benefit. See Video Abstract at http://links.lww.com/DCR/B560. VALORACIN DE LA IRRIGACIN DE LADO IZQUIERDO/RESECCIN ANTERIOR BAJA PILAR III UN ESTUDIO ALEATORIZADO, CONTROLADO, PARALELO Y MULTICNTRICO QUE EVALA LOS RESULTADOS DE LA IRRIGACIN CON PINPOINT IMGENES DE FLUORESCENCIA CERCANA AL INFRARROJO EN LA RESECCIN ANTERIOR BAJA: ANTECEDENTES:Se ha demostrado que la fluoroscopia con verde de indocianina mejora las tasas de fuga anastomótica en ensayos en fases iniciales.OBJETIVO:Nuestra hipótesis es que la utilización de fluoroscopia para asegurar la irrigación anastomótica puede disminuir la fuga anastomótica luego de una resección anterior baja.DISEÑO:Realizamos un estudio paralelo, controlado, aleatorizado 1:1. Se planificó el reclutamiento de 450-1000 pacientes durante 2 años.AMBITO:Multicéntrico.PACIENTES:Pacientes sometidos a resección definida como una anastomosis dentro de los 10cm del margen anal.INTERVENCIÓN:Pacientes que se sometieron a la evaluación estándar de la irrigación tisular contra la estándar en conjunto con la valoración de la irrigación mediante fluoroscopia con verde indocianina.PRINCIPALES VARIABLES EVALUADAS:El principal resultado fue la fuga anastomótica, y los resultados secundarios fueron la evaluación de la perfusión y la tasa de absceso posoperatorio que requirió intervención.RESULTADOS:Este estudio se cerró anticipadamente debido a la disminución de las tasas de acumulación. Un total de 25 centros reclutaron a 347 pacientes, de los cuales 178 fueron, de manera aleatoria, asignados a perfusión y 169 a estándar. Los grupos tenían datos demográficos específicos del tumor y del paciente similares. Recibieron quimio-radioterapia neoadyuvante el 63,5% de la perfusión y el 65,7% del estándar (p> 0,05). La anastomosis estuvo en un nivel promedio de 5,2 + 3,1 cm en perfusión en comparación con 5,2 + 3,3 cm en estándar (p> 0,05). Se reportó una visualización suficiente de la perfusión en el 95,4% de los pacientes del grupo de perfusión. El absceso posoperatorio que requirió tratamiento quirúrgico fue de 5,7% de los perfusion y en el 4,2% del estándar (p = 0,75). Se informó fuga anastomótica en el 9,0% de la perfusión en comparación con el 9,6% del estándar (p = 0,37). En el análisis de regresión multivariante, no hubo diferencias en las tasas de fuga anastomótica entre la perfusión y el estándar (OR 0,845; IC del 95% (0,375; 1,905); p = 0,34).LIMITACIONES:No se logró el tamaño de muestra predeterminado para reducir satisfactoriamente el riesgo de error tipo II.CONCLUSIÓN:Se puede obtener una visualización adecuada de la perfusión con ICG-F. Sin embargo, no se observaron diferencias en las tasas de fuga anastomótica entre los pacientes que se sometieron a evaluación de la perfusión versus la técnica quirúrgica estándar. En manos expertas, agregar ICG-F a la rutina de la práctica estándar no agrega ningún beneficio clínico evidente. Consulte Video Resumen en http://links.lww.com/DCR/B560. (Traducción-Dr Juan Antonio Villanueva-Herrero).

Robotic Versus Laparoscopic Surgery for Rectal Cancer: A Comprehensive Review of Oncological Outcomes.

The treatment of rectal cancer is complex and involves specialized multidisciplinary care, although the tenet is still rooted in a high-quality total mesorectal excision. The robotic platform is one of many tools in the arsenal to assist dissection in the low pelvis. This article is a comprehensive review of the oncological outcome comparing robotic vs laparoscopic rectal cancer resection, with a particular focus on total mesorectal excision. There is no statistical difference in total mesorectal grade, circumferential margin, distal margin, and lymph node harvest. Survival data are less mature, but there is also no difference in disease-free or overall survival between the two techniques. Although additional randomized trials are still needed to validate these findings, both techniques are currently acceptable in the minimally invasive treatment of rectal cancer, and surgeon preference is paramount to safe and optimal resection.

Watch-and-Wait Compared to Operation for Patients with Complete Response to Neoadjuvant Therapy for Rectal Cancer.

BACKGROUND: Trimodality therapy with neoadjuvant chemoradiation (nCRT), surgery, and adjuvant chemotherapy is the standard treatment for locally advanced rectal cancer. There is evidence that surgery can be deferred in patients with complete response (CR) to nCRT, a strategy termed "watch-and-wait" (WW). We compare WW to surgery in patients with CR to nCRT. STUDY DESIGN: We reviewed records of patients treated with nCRT for nonmetastatic rectal cancer at our institution. Complete endoscopic response (CER) was defined as negative digital rectal exam and negative endoscopy at the end of neoadjuvant therapy (NAT). Clinical complete response (cCR) was defined as CER with negative rectal MRI. Patients with CER refusing surgery were offered WW, which included strict surveillance with digital rectal exam and endoscopy. RESULTS: From January 2015 through February 2019, 465 patients completed nCRT; 406 patients had response assessment, of which 95 (23%) had CER. Of these patients, 53 patients underwent WW and 42 patients had surgery. Median follow-up was 35 months. In the WW group, 3-year freedom from local regrowth was 85%. In the surgical and WW groups, 3-year overall survival, rectal cancer-specific survival, and freedom from nonregrowth recurrence were 100% vs 88% (p = 0.03), 100% vs 95% (p = 0.16), and 92% vs 85% (p = 0.36), respectively. Of the 6 WW patients with local regrowth, 5 (83%) eventually developed distant recurrence. CONCLUSIONS: WW in lieu of surgery appears to be a safe and feasible treatment approach for patients achieving CR to nCRT. Careful evaluation to confirm cCR after nCRT is valuable in selecting patients for WW.

Learning Transanal Total Mesorectal Excision.

A dynamic evolution is occurring in transanal surgery. Transanal techniques began with intraluminal surgical removal of rectal masses and have progressed to transanal total mesorectal excision (taTME) for rectal cancer. TaTME was first performed in 2009 by Sylla, Rattner, Delgado, and Lacy. This article documents the training pathway followed by pioneers in the taTME technique as well as consensus reports outlining the process of learning the taTME technique. A literature search was performed for taTME training, learning, and technique. Key elements in learning the taTME technique include appropriate indications, cadaver training, and outcomes reporting such as participating in a taTME registry. Consensus reports also agree on the following facets associated with improved outcomes: (1) appropriate case selection of mid and low rectal cancers, (2) prerequisite completion of an accredited training program in laparoscopic colorectal surgery and prior experience in transanal endoscopic surgery, (3) a two-team taTME approach from above and below is ideal, and (4) higher rectal cancer volume surgical practice. The unifying international recommendation for surgeons interested in learning the taTME technique conveys the following message: taTME is an advanced and complex technique that requires dedicated training and experience in TME surgery.

Transrectal Ultrasound MRI-Fusion Biopsy of Perirectal Mass.

This case report describes the novel use of ultrasound-guided MRI-fusion biopsy to sample an extraluminal perirectal mass. This is a 64-year-old man with a history of pT3N2b mucinous adenocarcinoma of the right colon with metastatic disease to the mesocolic lymph nodes. Two years after initial resection he was found on restaging CT to have a mass measuring ∼4.0 × 4.8 cm superior to the seminal vesicles. Fluorodeoxyglucose (FDG)-positron emission tomography (PET) showed a moderately FDG avid soft tissue mass interposed between the prostate and the rectum. Multiparametric MRI revealed a 6.2 × 4.6 × 2.8 cm heterogeneous lobulated T2 hyperintense mass with enhancement just superior to the seminal vesicles. This mass was unable to be viewed using sigmoidoscopy. Using UroNAV technology, we were able to biopsy the mass in the clinic setting. Biopsy was confirmed as recurrent mucinous adenocarcinoma.

Transanal total mesorectal excision (taTME) for rectal cancer: beyond the learning curve.

BACKGROUND: Transanal total mesorectal excision (taTME) is a surgical approach for low rectal cancer with a learning curve estimated at 40-50 cases. The experience among taTME surgeons beyond their learning curve is limited. METHODS: A retrospective analysis of all taTME cases performed for rectal cancer at two tertiary care hospitals from 2014 to 2019 was conducted. Transanal surgeons had previously performed > 50 taTME cases. Demographic, perioperative, and short-term outcomes were analyzed. RESULTS: Among 54 taTME patients, 74.1% were male and 27.8% had a BMI ≥ 30. Tumors were stage I (8), II (13), III (29), and IV (4). Complex cases included 4 local recurrences, 4 prior liver resections, and 2 with prior prostate cancer. Thirty tumors were located ≤ 6 cm from the anal verge. On staging MRI, 12 had a positive predicted circumferential radial margin (+CRM), and 4 had internal anal sphincter involvement (+IAS). Forty-seven patients received neoadjuvant therapy. A 2-team approach was used in 51 patients with laparoscopic (83.3%) or robotic (16.7%) abdominal assistance with a 9.2% conversion rate. Low anterior resection with sphincter salvage was achieved in 87% with 8 patients requiring intersphincteric resection. Anastomoses were hand-sewn in 57.4% and all patients were diverted. Median LOS was 5 days with a 42.6% 30-day morbidity rate and 3 postoperative mortalities (ARDS, pulmonary embolism and pseudomembranous colitis). Complete and near complete TME grade was achieved in 94.4% with a 3.7% rate of +CRM. At a median follow-up of 28 months, local and distant recurrence rates were 3.9% and 17.6%, respectively, with no cancer-related mortality. CONCLUSION: Indications for taTME at experienced centers have expanded to include complex reoperative cases, local recurrences, metastatic cancer, and tumors with threatened CRM or IAS with evidence of post-treatment tumor regression. In the latter cases, taTME achieves good short-term outcomes and may facilitate R0 resection.

Transanal Total Mesorectal Excision (taTME) for Rectal Cancer: A Case Series Report of a Natural Orifice Surgical Technique.

In the treatment of colorectal cancer, total mesorectal excision (TME) has risen as the gold standard in the surgical treatment of this disease in order to obtain negative distal and circumferential radial margins. Since introduction in 2010, transanal TME has aimed to decrease the rate of positive margins and improve the quality of the dissection while decreasing the complications associated with a transabdominal low pelvic dissection. We retrospectively reviewed 25 cases of transanal TME completed between December 2014 and August 2017. Most of the patients in our case series were male (60%) with an average age of 57.1 years, BMI of 28.4 kg/m², and with an American Society of Anesthesiologists score of II. The average tumor was midrectal (about 5.9 cm from the anal verge), clinically T3-T4 (92%), and had undergone neoadjuvant therapy (96%). The average operation was about six hours and 44 minutes with ileostomy placed most of the time (92%). In all the cases where the TME quality was graded, the specimens were reported to have been complete (grade I). There were no positive distal, radial, or proximal margins. The average hospital stay was about 5.9 days. The rate of minor complications was about 48 per cent and major complications occurred about 16 per cent of the time.

Racial and Socioeconomic Treatment Disparities in Adolescents and Young Adults with Stage II-III Rectal Cancer.

INTRODUCTION: Stage II-III rectal cancer requires multidisciplinary cancer care, and adolescents and young adults (AYA, ages 15-39 years) often do not receive optimal cancer therapy. METHODS: Overall, 3295 AYAs with clinical stage II-III rectal cancer were identified in the National Cancer Database. Factors associated with the receipt of adjuvant and surgical therapies, as well as overall survival (OS), were examined. RESULTS: The majority of patients were non-Hispanic White (72.0 %), male (57.5 %), and without comorbidities (93.8 %). A greater proportion of Black and Hispanic patients did not receive radiation (24.5 and 27.1 %, respectively, vs. 16.5 % for non-Hispanic White patients), surgery (22.4 % and 21.6 vs. 12.3 %), or chemotherapy (21.5 % and 24.1 vs. 14.7 %) compared with non-Hispanic White patients (all p < 0.05). After controlling for competing factors, Black (odds ratio [OR] 0.7, 95 % confidence interval [CI] 0.5-0.9) and Hispanic patients (OR 0.6, 95 % CI 0.4-0.9) were less likely to receive neoadjuvant chemoradiation compared with non-Hispanic White patients. Females, the uninsured, and those treated at a community cancer center were also less likely to receive neoadjuvant therapy. Having government insurance (OR 0.22, 95 % CI 010-0.49) was a predictor for not receiving surgery. Although 5-year OS was lower (p < 0.05) in Black (59.8 %) and Hispanic patients (65.9 %) compared with non-Hispanic White patients (74.9 %), on multivariate analysis race did not impact mortality. Not having surgery (hazard ratio [HR] 7.1, 95 % CI 2.8-18.2) had the greatest influence on mortality, followed by poorly differentiated histology (HR 3.0, 95 % CI 1.3-6.5), nodal positivity (HR 2.6, 95 % CI 1.9-3.6), no chemotherapy (HR 1.9, 95 % CI 1.03-3.6), no insurance (HR 1.7, 95 % CI 1.1-2.7), and male sex (HR 1.5, 95 % CI 1.1-2.0). CONCLUSION: There are racial and socioeconomic disparities in the treatment of stage II-III rectal cancer in AYAs, many of which impact OS. Interventions that can address and mitigate these differences may lead to improvements in OS for some patients.

Anal Health Care Basics.

Despite the fact that countless patients suffer from anal problems, there tends to be a lack of understanding of anal health care. Unfortunately, this leads to incorrect diagnoses and treatments. When treating a patient with an anal complaint, the primary goals are to first diagnose the etiology of the symptoms correctly, then to provide an effective and appropriate treatment strategy.The first step in this process is to take an accurate history and physical examination. Specific questions include details about bowel habits, anal hygiene, and fiber supplementation. Specific components of the physical examination include an external anal examination, a digital rectal examination, and anoscopy if appropriate.Common diagnoses include pruritus ani, anal fissures, hemorrhoids, anal abscess or fistula, fecal incontinence, and anal skin tags. However, each problem presents differently and requires a different approach for management. It is of paramount importance that the correct diagnosis is reached. Common errors include an inaccurate diagnosis of hemorrhoids when other pathology is present and subsequent treatment with a steroid product, which is harmful to the anal area.Most of these problems can be avoided by improving bowel habits. Adequate fiber intake with 30 g to 40 g daily is important for many reasons, including improving the quality of stool and preventing colorectal and anal diseases.In this Special Report, we provide an overview of commonly encountered anal problems, their presentation, initial treatment options, and recommendations for referral to specialists.