Local Recurrence-Free Survival After TaTME: A Canadian Institutional Experience.

BACKGROUND: Transanal total mesorectal excision is a novel surgical treatment for mid to low rectal cancers. Norwegian population data have raised concerns about local recurrence in patients treated with transanal total mesorectal excision. OBJECTIVE: This study aimed to analyze local recurrence and disease-free survival in patients treated by transanal total mesorectal excision for rectal cancer at a high-volume tertiary center. DESIGN: This retrospective study used a prospectively maintained institutional transanal total mesorectal excision database. Patient demographics, treatment, and outcomes data were analyzed. Local recurrence, disease-free survival, and overall survival were analyzed using Kaplan-Meier analysis. SETTINGS: The study was conducted at a single academic institution in Vancouver, Canada. PATIENTS: All patients treated by transanal total mesorectal excision for rectal adenocarcinoma between 2014 and 2022 were included. MAIN OUTCOME MEASURES: The primary outcome was local recurrence-free survival. RESULTS: Between 2014 and 2022, 306 patients were treated by transanal total mesorectal excision at St. Paul's Hospital. Of these, 279 patients met the inclusion criteria. The mean age was 62 years (SD ± 12.3), and 66.7% of patients were men. Restorative resection was achieved in 97.5% of patients, with a conversion rate from laparoscopic to open surgery of 6.8%. The composite optimal pathological outcome was 93.9%. The median follow-up was 26 months (interquartile range, 12-47), and 82.8% of patients achieved reestablishment of GI continuity to date. The overall local recurrence rate was 4.7% (n = 13). The estimated 2-year local recurrence-free survival rate was 95.0% (95% CI, 92-98) and the estimated 5-year local recurrence-free survival rate was 94.5% (95% CI, 91-98). LIMITATIONS: Limitations include the retrospective nature of the study and the generalizability of a Canadian population. CONCLUSIONS: Recent European data have challenged the presumed oncologic safety of transanal total mesorectal excision. Although the learning curve for this procedure is challenging and poor outcomes are associated with low volume, this high-volume single-center study confirms acceptable oncologic outcomes consistent with the current standard. See Video Abstract . SOBREVIDA SIN RECIDIVA DESPUS DE TATME EXPERIENCIA INSTITUCIONAL CANADIENSE: ANTECEDENTES:La excisión total del mesorecto por vía transanal es un tratamiento quirúrgico novedoso para los cánceres de recto medio a bajo. Estudios sobre la población noruega han generado preocupación debido a la recidiva local en pacientes tratados con excisión total del mesorecto por vía transanal.OBJETIVO:Nuestra finalidad fué de analizar la recidiva local y la sobrevida libre de enfermedad en pacientes tratados mediante la excisión total del mesorecto por vía transanal, debido a un cáncer de recto en un centro terciario de alto volúmen.DISEÑO:El presente estudio retrospectivo, utiliza una base de datos institucional sobre la excisión total del mesorecto por vía transanal mantenida prospectivamente. Se analizaron los datos demográficos, de tratamiento y los resultados de los pacientes sometidos a la técnica mencionada. La recidiva local, la sobrevida libre de enfermedad y la sobrevida global se analizaron mediante el modelo de Kaplan-Meier.AJUSTES:El estudio se llevó a cabo en una sola institución académica en Vancouver, Canadá.PARTICIPANTES:Se incluyeron todos los pacientes tratados mediante excisión total del mesorecto por vía transanal causado por adenocarcinomas de recto entre 2014 y 2022.PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue la sobrevida libre de recidiva local.RESULTADOS:Entre 2014 y 2022, 306 pacientes fueron tratados mediante la excisión total del mesorecto por vía transanal en el Hospital St. Paul. De estos, 279 pacientes cumplieron los criterios de inclusión. La edad media fue de 62 años (DE ± 12,3) y el 66,7% de los pacientes eran varones. La resección restauradora se logró en el 97,5% de los pacientes con una tasa de conversión de cirugía laparoscópica en laparotomía del 6,8%. El resultado patológico óptimo combinado fué del 93,9%. La mediana de seguimiento fue de 26 meses (rango intercuartil 12-47) y el 82,8% logró el restablecimiento de la continuidad gastrointestinal hasta la fecha. La tasa global de recidiva local fué del 4,7% (n = 13). La sobrevida libre de recidiva local estimada a los 2 años fué del 95,0% (IC del 95%: 92-98) y del 94,5% a los 5 años (IC del 95%: 91-98).LIMITACIONES:Las limitaciones incluyen la naturaleza retrospectiva del estudio y la generalización de una población canadiense.CONCLUSIONES:Datos europeos recientes han cuestionado la supuesta seguridad oncológica de la excisión total del mesorecto por vía transanal. Si bien la curva de aprendizaje de este procedimiento es muy desafiante y los malos resultados se asocian con un volumen bajo, el presente estudio, unicéntrico de gran volumen confirma los resultados oncológicos aceptables consistentes con el estándar actual. (Traducción-Dr. Xavier Delgadillo ).

Surgical Outcomes in Total Neoadjuvant Therapy for Rectal Cancer Versus Standard Long-course Chemoradiation: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

OBJECTIVE: This systematic review and meta-analysis seeks to evaluate the impact of total neoadjuvant therapy (TNT) for rectal cancers on surgical complications and surgical pathology when compared with standard long-course chemoradiotherapy (LCRT). BACKGROUND: The oncological benefits of TNT are well published in previous meta-analyses, but there is little synthesized information on how it affects surgical outcomes. A recent study has suggested an increase in local recurrence and higher rates of breached total mesorectal excision (TME) plane in TNT patients. METHODS: This study conformed to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. A search was performed in Medline (via PubMed), Cochrane databases, EMBASE and CINAHL to identify relevant randomized controlled trials (RCTs) comparing outcomes between TNT and LCRT. Meta-analyses of pooled proportions between TNT and LCRT were performed, comparing primary outcomes of surgical mortality, morbidity and all reported complications; surgical-pathology differences, namely mesorectal quality, R0 resection rates, circumferential resection margin positive rates, and sphincter preservation rates. Death and progression of disease during neoadjuvant treatment period was also compared. Risk of bias of RCTs was performed using the Cochrane risk-of-bias tool by 2 independent reviewers. RESULTS: A total of 3185 patients with rectal cancer from 11 RCTs were included in the analysis: 1607 received TNT and 1578 received LCRT, of which 1422 (TNT arm) and 1391 (LCRT arm) underwent surgical resection with curative intent. There was no significant difference in mortality [risk ratio (RR)=0.86, 95% CI: 0.13-5.52, P =0.88, I2 =52%] or major complications (RR=1.04, 95% CI: 0.86-1.26, P =0.70, I2 =0%) between TNT and LCRT. There was a significantly higher risk of breached TME in TNT group on pooled analysis (RR=1.49, 95% CI: 1.03-12.16, P =0.03, I2 =0%), and on subgroup analysis there is higher risk of breached TME in those receiving extended duration of neoadjuvant treatment (>17 weeks from start of treatment to surgery) when compared with LCRT (RR=1.61, 95% CI: 1.06-2.44, P =0.03). No difference in R0 resection rates (RR=0.85, 95% CI: 0.66-1.10, P =0.21, I2 =15%), circumferential resection margin positive rates (RR=0.87, 95% CI: 0.65-1.16, P =0.35, I2 =10%) or sphincter preservation rates (RR=1.02, 95% CI: 0.83-1.25, P =0.88, I2 =57%) were observed. There was a significantly lower risk of progression of disease to an unresectable stage during the neoadjuvant treatment period in TNT patients (RR=0.60, 95% CI: 0.39-0.92, P =0.03, I2 =18%). On subgroup analysis, it appears to favor those receiving extended duration of neoadjuvant treatment (RR=0.44, 95% CI: 0.26-0.80, P =0.002), and those receiving induction-type chemotherapy in TNT (RR=0.25, 95% CI: 0.07-0.88, P =0.03). CONCLUSIONS: TNT increases rates of breached TME which can contribute to higher local recurrence rates. TNT, however, improves systemic control by reducing early progression of disease during neoadjuvant treatment period. Further research is warranted to identify patients that will benefit from this strategy.

Local versus radical surgery for early rectal cancer with or without neoadjuvant or adjuvant therapy.

BACKGROUND: Total mesorectal excision is the standard of care for stage I rectal cancer. Despite major advances and increasing enthusiasm for modern endoscopic local excision (LE), uncertainty remains regarding its oncologic equivalence and safety relative to radical resection (RR). OBJECTIVES: To assess the oncologic, operative, and functional outcomes of modern endoscopic LE compared to RR surgery in adults with stage I rectal cancer. SEARCH METHODS: We searched CENTRAL, Ovid MEDLINE, Ovid Embase, Web of Science - Science Citation Index Expanded (1900 to present), four trial registers (ClinicalTrials.gov, ISRCTN registry, the WHO International Clinical Trials Registry Platform, and the National Cancer Institute Clinical Trials database), two thesis and proceedings databases, and relevant scientific societies' publications in February 2022. We performed handsearching and reference checking and contacted study authors of ongoing trials to identify additional studies. SELECTION CRITERIA: We searched for randomized controlled trials (RCTs) in people with stage I rectal cancer comparing any modern LE techniques to any RR techniques with or without the use of neo/adjuvant chemoradiotherapy (CRT). DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. We calculated hazard ratios (HR) and standard errors for time-to-event data and risk ratios for dichotomous outcomes, using generic inverse variance and random-effects methods. We regrouped surgical complications from the included studies into major and minor according to the standard Clavien-Dindo classification. We assessed the certainty of evidence using the GRADE framework. MAIN RESULTS: Four RCTs were included in data synthesis with a combined total of 266 participants with stage I rectal cancer (T1-2N0M0), if not stated otherwise. Surgery was performed in university hospital settings. The mean age of participants was above 60, and median follow-up ranged from 17.5 months to 9.6 years. Regarding the use of co-interventions, one study used neoadjuvant CRT in all participants (T2 cancers); one study used short-course radiotherapy in the LE group (T1-T2 cancers); one study used adjuvant CRT selectively in high-risk patients undergoing RR (T1-T2 cancers); and the fourth study did not use any CRT (T1 cancers). We assessed the overall risk of bias as high for oncologic and morbidity outcomes across studies. All studies had at least one key domain with a high risk of bias. None of the studies reported separate outcomes for T1 versus T2 or for high-risk features. Low-certainty evidence suggests that RR may result in an improvement in disease-free survival compared to LE (3 trials, 212 participants; HR 1.96, 95% confidence interval (CI) 0.91 to 4.24). This would translate into a three-year disease-recurrence risk of 27% (95% CI 14 to 50%) versus 15% after LE and RR, respectively. Regarding sphincter function, only one study provided objective results and reported short-term deterioration in stool frequency, flatulence, incontinence, abdominal pain, and embarrassment about bowel function in the RR group. At three years, the LE group had superiority in overall stool frequency, embarrassment about bowel function, and diarrhea. Local excision may have little to no effect on cancer-related survival compared to RR (3 trials, 207 participants; HR 1.42, 95% CI 0.60 to 3.33; very low-certainty evidence). We did not pool studies for local recurrence, but the included studies individually reported comparable local recurrence rates for LE and RR (low-certainty evidence). It is unclear if the risk of major postoperative complications may be lower with LE compared with RR (risk ratio 0.53, 95% CI 0.22 to 1.28; low-certainty evidence; corresponding to 5.8% (95% CI 2.4% to 14.1%) risk for LE versus 11% for RR). Moderate-certainty evidence shows that the risk of minor postoperative complications is probably lower after LE (risk ratio 0.48, 95% CI 0.27 to 0.85); corresponding to an absolute risk of 14% (95% CI 8% to 26%) for LE compared to 30.1% for RR. One study reported an 11% rate of temporary stoma after LE versus 82% in the RR group. Another study reported a 46% rate of temporary or permanent stomas after RR and none after LE. The evidence is uncertain about the effect of LE compared with RR on quality of life. Only one study reported standard quality of life function, in favor of LE, with a 90% or greater probability of superiority in overall quality of life, role, social, and emotional functions, body image, and health anxiety. Other studies reported a significantly shorter postoperative period to oral intake, bowel movement, and off-bed activities in the LE group. AUTHORS' CONCLUSIONS: Based on low-certainty evidence, LE may decrease disease-free survival in early rectal cancer. Very low-certainty evidence suggests that LE may have little to no effect on cancer-related survival compared to RR for the treatment of stage I rectal cancer. Based on low-certainty evidence, it is unclear if LE may have a lower major complication rate, but probably causes a large reduction in minor complication rate. Limited data based on one study suggest better sphincter function, quality of life, or genitourinary function after LE. Limitations exist with respect to the applicability of these findings. We identified only four eligible studies with a low number of total participants, subjecting the results to imprecision. Risk of bias had a serious impact on the quality of evidence. More RCTs are needed to answer our review question with greater certainty and to compare local and distant metastasis rates. Data on important patient outcomes such as sphincter function and quality of life are very limited. Results of currently ongoing trials will likely impact the results of this review. Future trials should accurately report and compare outcomes according to the stage and high-risk features of rectal tumors, and evaluate quality of life, sphincter, and genitourinary outcomes. The role of neoadjuvant or adjuvant therapy as an emerging co-intervention for improving oncologic outcomes after LE needs to be further defined.

Safety and Efficacy of Iltamiocel Cellular Therapy for the Treatment of Fecal Incontinence. Results of a Phase 1/2 Study.

OBJECTIVE: To examine the safety and efficacy of iltamiocel, an investigational cellular therapy of autologous muscle-derived cells, as a treatment for fecal incontinence (FI) in adults. BACKGROUND: Limited therapeutic options are available for patients with FI refractory to conservative treatments. Cell therapy using autologous muscle-derived cells represents a promising, minimally invasive approach for restoring anal sphincter function. METHODS: In this multicenter, prospective, non-randomized study, 48 participants were treated with a single iltamiocel dose of 250×10 6 cells. The primary outcome was the incidence of product or procedure-related adverse events (AEs) and serious AEs. Secondary outcomes were changes in the number of FI episodes, Cleveland Clinic Incontinence Score, Fecal Incontinence Quality of Life, and anorectal manometry at 3, 6, and 12 months compared to baseline. RESULTS: No serious AEs and only one product-related AE of inflammation at the injection site were reported. At 12 months, there was a reduction in median FI episodes (-6.0; 95% confidence interval (CI): -10.0, -1.0) and days with episodes (-4.0; 95% CI: -8.0, -1.0). A ≥50% reduction in FI episodes was observed in 53.7% of participants, and 24.4% had complete restoration of continence. Symptom severity and quality of life improved with mean Cleveland Clinic Incontinence Score reduction (-2.9; 95% CI: -3.7, -2.1), and Fecal Incontinence Quality of Life increased (2.2; 95% CI:1.4, 2.9). No significant changes were detected in anorectal manometry measurements. A history of episiotomy was significantly associated with treatment response in multivariate analysis. CONCLUSION: The administration of iltamiocel cellular therapy is safe. Iltamiocel shows promise for significantly improving fecal incontinence symptoms and quality of life.

Oncological Outcomes of Transanal Endoscopic Surgery for the Surgical Management of T2 and T3 Rectal Cancer.

BACKGROUND: Transanal endoscopic surgery is an organ-sparing treatment for early rectal cancer. Patients with advanced lesions are recommended for total mesorectal excision. However, some patients have prohibitive comorbidities or refuse major surgery. OBJECTIVE: To assess the cancer outcomes of patients with T2 or T3 rectal cancers who received transanal endoscopic surgery as their sole surgical treatment. DESIGN: This study used a prospectively maintained database. SETTING: A tertiary hospital in Canada. PATIENTS: Patients who underwent transanal endoscopic surgery for pathology-confirmed T2 or T3 rectal adenocarcinomas from 2007-2020 were included. MAIN OUTCOME MEASURES: Disease-free survival and overall survival, stratified by tumor stage and reason for transanal endoscopic surgery. RESULTS: Among the included 132 patients (T2, n = 96; T3, n = 36), average follow-up was 22 months. Twenty-eight decline oncologic resection, whereas 104 had preclusive comorbidities. Fifteen patients (11.4%) had disease recurrence (4 local, 11 metastatic). Three-year disease-free survival was 86.5% (95% CI, 77.1-95.9) for T2 and 67.9% (95% CI, 46.3-89.5) for T3 tumors. Mean disease-free survival was longer for T2 (75.0 mo; 95% CI, 67.8-82.1) compared to T3 cancers (50 mo; 95% CI, 37.7-62.3; p = 0.037). Three-year disease-free survival for patients who declined radical excision was 84.0% (95% CI, 67.1-100) versus 80.7% (95% CI, 69.7-91.7) in patients too comorbid for surgery. Three-year overall survival rate was 84.9% (95% CI, 73.9-95.9) for T2 and 49.0% (95% CI, 26.7-71.3) for T3 tumors. Patients who declined radical resection had similar 3-year overall survival (89.7%; 95% CI, 76.2-100) compared to patients who were unable to undergo excision because of medical comorbidities (98.1%; 95% CI, 95.6-100). LIMITATIONS: Small sample, single institution, and surgeon experience. CONCLUSIONS: Oncologic outcomes are compromised in patients treated by transanal endoscopic surgery for T2 and T3 rectal cancer. Transanal endoscopic surgery remains an option for informed patients who prefer to avoid radical resection. See Video Abstract at http://links.lww.com/DCR/C200 . RESULTADOS ONCOLGICOS DE LA CIRUGA ENDOSCPICA TRANSANAL PARA EL MANEJO QUIRRGICO DEL CNCER DE RECTO T Y T: ANTECEDENTES:La cirugía endoscópica transanal es un tratamiento de conservación de órganos para el cáncer de recto en estadio temprano. A los pacisentes con lesiones avanzadas se les recomienda la escisión total del mesorrecto. Sin embargo, algunos pacientes tienen comorbilidades prohibitivas o rechazan una cirugía mayor.OBJETIVO:Evaluar los resultados del cáncer de pacientes con cáncer de recto T2 o T3 que recibieron cirugía endoscópica transanal como único tratamiento quirúrgico.DISEÑO:Este estudio utilizó una base de datos mantenida prospectivamente.ENTORNO CLINICO:Un hospital terciario en CanadáPACIENTES:Aquellos que se sometieron a cirugía endoscópica transanal por adenocarcinomas rectales T2 o T3 confirmados por patología de 2007-2020. Se excluyeron los pacientes cuya cirugía se realizó por recurrencia del cáncer o posteriormente fueron sometidos a resección radical.PRINCIPALES MEDIDAS DE VALORACIÓN:Supervivencia libre de enfermedad y supervivencia global, estratificada por estadio del tumor y motivo de la cirugía endoscópica transanal.RESULTADOS:Se incluyeron 132 pacientes (T2, n = 96; T3, n = 36). El seguimiento medio fue de 22 meses (DE ± 23,4). 104 pacientes tenían comorbilidades significativas, mientras que 28 rechazaron la resección oncológica. Quince pacientes (11,4%) tuvieron recurrencia de la enfermedad (4 locales, 11 metastásicos). La supervivencia libre de enfermedad a los tres años para los tumores T2 fue del 86,5 % (IC del 95%: 77,1-95,9) y del 67,9% (IC del 95%: 46,3-89,5) para los tumores T3. La supervivencia libre de enfermedad media fue más prolongada para los cánceres T2 (75,0 meses, IC del 95%: 67,8 a 82,1) en comparación con los cánceres T3 (50 meses, IC del 95%: 37,7 a 62,3, p = 0,037). La supervivencia sin enfermedad a los tres años para los pacientes que rechazaron la escisión mesorrectal total fue del 84,0% (IC del 95%: 67,1-100), mientras que los pacientes con demasiada comorbilidad médica para la cirugía tuvieron una supervivencia sin enfermedad a los tres años del 80,7% (IC del 95%: 69.7-91.7). La supervivencia general a los tres años fue del 84,9% (IC del 95%: 73,9 a 95,9) para los tumores T2 y del 49,0% (IC del 95%: 26,7 a 71,3) para los tumores T3. Los pacientes que rechazaron la resección radical tuvieron una supervivencia general similar a los tres años (89,7%, IC del 95%: 76,2-100), en comparación con los pacientes que no pudieron someterse a una escisión mesorrectal total debido a comorbilidades médicas (98,1%, IC del 95%: 95,6-100).LIMITACIONES:Muestra pequeña, institución única, experiencia del cirujano.CONCLUSIONES:Los resultados oncológicos están comprometidos en pacientes tratados con cirugía endoscópica transanal por cáncer de recto T2 y T3. Sin embargo, la cirugía endoscópica transanal sigue siendo una opción para pacientes informados que prefieren evitar la resección radical. Consulte Video Resumen en http://links.lww.com/DCR/C200 . (Traducción-Dr. Ingrid Melo ).

Management of rectal neuroendocrine tumours by transanal endoscopic microsurgery.

AIM: The objective of this study was to evaluate the safety and effectiveness of transanal endoscopic microsurgery for rectal neuroendocrine tumours. METHOD: A retrospective cohort study of all pathology-confirmed rectal neuroendocrine tumours treated by transanal endoscopic microsurgery from April 2007 to December 2020 at a tertiary care centre was performed. Demographic, clinical, radiographic and pathological data were collected. Characteristics of patients with recurrence were examined. Descriptive statistics were performed. RESULTS: There were 58 patients treated by transanal endoscopic microsurgery excision. Referrals were for primary excision (15, 25.9%), completion re-excision after incomplete endoscopic removal (38, 65.5%) or locally recurrent rectal neuroendocrine tumours (5, 8.6%). The mean age of patients was 56.4 ± 11.9 years and 26 patients were women (44.8%). Mean tumour size was 7.4 ± 3.8 mm (range 1.0-15.0 mm). Most (86.4%) were Grade 1 tumours. Mean operative time was 37.2 ± 17.2 min and 56 patients (96.6%) were discharged on the same day. All patients had negative margins on final pathology. Of the 38 patients who were referred for completion re-excision after incomplete endoscopic removal, eight (21.1%) had residual tumour on final pathology. Three recurrences were diagnosed at 2.1, 4.5 and 12.5 years after excision. All recurrences were from Grade 1 or 2 primary tumours, less than 2 cm, and diagnosed radiographically. CONCLUSION: To date, this is the largest North American study looking at transanal endoscopic microsurgery for rectal neuroendocrine tumours. This technique is effective in managing primary, incompletely excised and recurrent tumours with good clinical and oncological outcomes.

A comparison of perineal stapled prolapse resection and the Altemeier procedure at 2 Canadian academic hospitals.

BACKGROUND: The preferred perineal repair method for full-thickness rectal prolapse is the Altemeier procedure, a perineal proctosigmoidectomy with handsewn anastomosis. A recently described variant of this procedure combines the resection and anastomosis into 1 step by means of linear and transverse stapling. There are few published data comparing the characteristics and outcomes of these 2 approaches. METHODS: This retrospective review, performed at 2 Canadian academic hospitals, compares surgical and cost outcomes between the perineal stapled prolapse resection (PSPR) and the Altemeier procedure. All patients who underwent these procedures between 2015 and 2019 were included. RESULTS: There were 25 patients in the PSPR group and 19 in the Altemeier group. Patients in the PSPR group were significantly older than those in the Altemeier group (81 [95% confidence interval (CI) 70-92] yr v. 74 [95% CI 63-85] yr; p = 0.047), had a lower body mass index (21.4 [95% CI 17.7-25.1] v. 24.4 [95% CI 18.5-30.3]; p = 0.042) and had equivalent American Society of Anesthesiologists scores (2.84 [95% CI 2.09-3.59] v. 2.68 [95% CI 1.93-3.43]; p = 0.49). The operative time for PSPR was significantly less (30.3 [95% CI 16.3-44.3] min v. 67 [95% CI 43-91] min; p < 0.001), as were the operative costs. Recurrence (28.0% v. 36.8%; p = 0.53) and complication rates were equivalent. CONCLUSION: PSPR is a safe, efficient and effective approach to perineal proctosigmoidectomy. It is associated with surgical outcomes comparable to those of the Altemeier procedure, but with a significant reduction in operative time and cost.

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.

Patterns of Healthcare Utilization Leading to Diagnosis of Young-Onset Colorectal Cancer (yCRC): Population-Based Case-Control Study.

Background: The increasing risk of young-onset colorectal cancer (yCRC) in adults < 50 years has called for better understanding of patients' pathways to diagnosis. This study evaluated patterns of healthcare utilization before diagnosis of yCRC. Methods: Using linked administrative health databases in British Columbia, Canada, we identified yCRC cases and cancer-free controls matched (1:10) on age, sex, and healthcare utilization. The index date was the date of diagnosis for yCRC cases and matched date for controls. Outpatient visits, emergency department visits, and hospitalizations over a 5-year prediagnosis period (e.g., year-1 to year-5) were compared using descriptive statistics and Poisson regression models. Results: The study included 2567 yCRC cases (49.6% females, 43.0 ± 5.8 years) and 25,455 controls (48.6% females, 43.0 ± 5.8 years). We observed an increasing number of outpatient visits from prediagnosis year-5 (median = 3) to year-1 (median = 8) for yCRC cases. Among controls, outpatient visits were stable and did not have a pattern of increase. Poisson regression models indicated higher adjusted count ratios for outpatient visits for yCRC cases compared to controls in the year before diagnosis (1.11; 95% CI, 1.07 to 1.15). In the year before diagnosis, 35.1% of yCRC cases had potentially related visits to CRC (e.g., nausea, vomiting) and 16.9% had potentially red flag visits (e.g., gastrointestinal hemorrhage or iron deficiency anemia). Conclusions: Using population-based data, we found that individuals with yCRC did not have higher healthcare utilization than individuals without in the prediagnosis period except for the year before diagnosis.

Home to Stay: A randomized controlled trial protocol to assess use of a mobile app to reduce readmissions following colorectal surgery.

AIM: Patients undergoing colorectal surgery face high rates of emergency room visits and readmission to hospital. These unplanned hospital visits lead to both increased patient anxiety and health care costs. The aim of this study is to evaluate the use of mobile application to support patients undergoing colorectal surgery following discharge from hospital. METHOD: This study is a randomized controlled trial in which the control group will receive standard follow-up care following discharge after surgery and the intervention group will receive standard follow-up care in addition to the mobile application. The primary outcome is the proportion of patients with unplanned hospital visits within 30 days of discharge. The secondary outcomes are patient-reported outcomes on validated scales evaluating their quality of recovery following discharge. A sample size of 670 subjects is planned. For the primary outcome, the control and intervention groups will be compared using a generalized linear model to account for clustering of patients within centres. For the secondary outcomes, the overall scores on the Quality of Recovery 15 and Patient Activation Measure will be analysed using a linear regression model. RESULTS: It is expected that the results of this study will show that the mobile app will lead to significant improvements in unplanned hospital visits as well as improved quality of recovery for patients. CONCLUSION: If the trial is successful, the mobile app can be easily adopted more widely into clinical practice to support patients at home following surgery.

Effectiveness of a rectal cancer education video on patient expectations.

AIM: Discrepancy between patient expectations and outcomes can negatively affect patient satisfaction and quality of life. We aimed to assess patient expectations of bowel, urinary, and sexual function after rectal cancer treatments, and whether a preoperative education video changed expectations. METHODS: A total of 45 patients were assessed between January 2018 and January 2021 in a tertiary care hospital in Vancouver, Canada. Patients included were rectal cancer patients who had neoadjuvant chemoradiation and were listed for low anterior resection but had not yet had surgery. Following surgical consultation but before surgery, a questionnaire assessing expectations of lifestyle after treatments was administered. Patients then watched an educational video and repeated the questionnaire to assess for changes in expectations. RESULTS: Patient scores indicated expectation that control of bowel movements, urination, and sexual function would sometimes be problematic, but had a range from occasionally problematic to good function. Significant change after the video was seen in the expectation of needing medications for bowel control, and 44%-69% of individual patient answers changed from prevideo to post-video, depending on the question. The education video was scored as helpful or very helpful by 82% of patients. CONCLUSIONS: Patients have varying expectations of problematic control of bowel, urinary, and sexual function following rectal cancer treatments. A pretreatment education video resulted in a trend toward changed expectations for functional outcomes in most patients. Further educational modalities for patients may provide more uniform expectations of function and increase patient satisfaction after rectal cancer treatments.

The relationship between perceptions of shared decision-making and patient-reported outcomes in a cross-sectional cohort of haemorrhoidectomy patients.

AIM: Shared decision-making between patients and clinicians is important to surgical practice and patients' perceptions of their healthcare experience. This study aims to measure associations between patients' perceptions of their shared decision-making (SDM) process and health-related quality of life among a cohort of patients choosing surgical management of an elective surgical procedure, haemorrhoidectomy. METHODS: This study is a single-site study based in Vancouver, Canada. Consecutive patients of five colorectal surgeons registered for elective haemorrhoidectomy between September 2016 and June 2020 were eligible to participate. Participants completed the CollaboRATE instrument which measures patients' perceptions of their SDM after the surgical consultation, along with a number of other patient-reported outcomes. RESULTS: The participation rate was 45.3%, with 157 patients scheduled for haemorrhoidectomy providing complete information. Unadjusted results found that participants having the most comorbidities reported better communication with their surgeon. The adjusted results show that socioeconomic status and depression were associated with lower CollaboRATE scores. There was no effect of sex, pain interference, anxiety or perceived health status on participants' CollaboRATE scores. CONCLUSION: This study found evidence that participants with lower economic status or those reporting depressive symptoms had worse perceptions of their SDM process with their surgeon. These findings suggest that special attention should be paid to the surgical decision-making process for these patient populations.

Prophylactic tamsulosin and urinary retention rates following elective colorectal surgery: a retrospective cohort study.

PURPOSE: Postoperative urinary retention (POUR) is a known morbidity after colorectal surgery. This study investigated the effect of prophylactic tamsulosin on urinary retention rates after colorectal surgery. METHODS: A retrospective cohort study of male patients 50 years or older undergoing elective colonic and rectal resections from May 2014 to November 2019 was performed. The intervention assessed was prophylactic tamsulosin use. POUR, defined by requiring intermittent or reinsertion of urinary catheter, was compared using chi-squared analysis. RESULTS: A total of 332 patients were included, 131 received no tamsulosin, and 201 received prophylactic tamsulosin. Overall POUR was significantly reduced (16.8% vs. 9.5%, p = 0.047). Subgroup analysis for age 50-59 revealed no difference (9.1% vs. 9.4%, p = 0.96), but POUR risk was significantly lower in age 60 and older (20.7% vs. 9.5%, p = 0.02). No significant difference was found in rectal resections alone (18.2% vs. 13.2%, p = 0.34). CONCLUSION: Prophylactic tamsulosin reduced POUR after colorectal surgery with the greatest effect in men 60 years or older and colonic resections.

Oncologic Outcomes Associated With MRI-detected Extramural Venous Invasion (mrEMVI) in Rectal Cancer: A Systematic Review and Meta-analysis.

BACKGROUND: The role of MRI-detected EMVI (mrEMVI) as a reliable prognostic factor in rectal cancer has been emphasized in recent years but this finding remains underreported by many institutions. OBJECTIVE: This review aimed to demonstrate the importance of pre- and post-treatment MRI-detected EMVI as independent prognostic factors of adverse oncologic outcomes in patients undergoing neoadjuvant therapy followed by total mesorectal excision. METHODS: This review was designed using the PRISMA guidelines. The following electronic databases were searched from January 2002 to January 2020: CENTRAL, Ovid MEDLINE, PubMed, and Ovid Embase. Main outcomes included DFS and overall survival (OS). Other outcomes of interest comprised positive resection margin and synchronous metastases. RESULTS: Seventeen studies involving a total of 3821 patients were included for data synthesis. For preneoadjuvant treatment mrEMVI, pooled hazard ratio (HR) estimate for DFS was 2.30 (95% confidence intervals (CI) 1.54-3.44) for higher recurrence in mrEMVI-positive patients. mrEMVI-positive patients were found to have a lower OS with a pooled HR of 1.68 (95%CI 1.27-2.22). Pooled risk ratio for synchronous metastasis was 4.11 (95%CI 2.80-6.02) for mrEMVI-positivity. For postneoadjuvant treatment EMVI (ymrEMVI), positive status showed a lower DFS with a pooled HR of 2.04 (95%CI 1.55-2.69). Risk ratio of having a positive resection margin status was 2.95 (95%CI 1.75-4.98) for ymrEMVI-positive patients. CONCLUSIONS: This review showed that oncologic outcomes are significantly worse for both pre- and post-neoadjuvant treatment mrEMVI-positive patients. MRI-detected EMVI should be consistently reported in rectal cancer staging and may provide guidance for the targeted use of additional systemic therapy.

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.

Colorectal surgery surgical site infection prevention practices in British Columbia.

Surgical site infections (SSI) pose significant morbidity after colorectal surgery. We sought to document current practices in colorectal surgery SSI prevention in British Columbia (BC). Reporting the current provincial landscape on SSI prevention helps to understand the foundation upon which improvements can take place. We surveyed all BC surgeons performing elective colon and rectal resections, and 97 surveys were completed (60% response rate). Eighty-six per cent of respondent hospitals tracked SSI rates. The reported superficial SSI was less than 5% and the anastomotic leak/organ space rate was less than 10%. All respondents gave preoperative prophylactic antibiotics, with 24% continuing antibiotics postoperatively; 62% are using oral antibiotics (OAB) and mechanical bowel preparation (MBP) and 29% use MBP without OAB. Areas for improvement include OAB with MBP and discontinuing prophylactic antibiotics postoperatively, as recommended by the World Health Organization.

Long-term outcomes after seton placement for perianal fistulas with and without Crohn's disease.

AIM: Perianal sepsis in Crohn's disease (CD) fistulas is managed with antibiotics and surgical drainage; a noncutting seton is used for an identified transsphincteric fistula tract. The optimal management following seton placement for initial control of perianal sepsis remains to be determined. Our main aim was to assess the success rates of curative surgery, seton removal or long-term indwelling seton in patients with and without CD. METHOD: This was a retrospective cohort of consecutive patients with a perianal fistula treated with a noncutting seton between 2010 and 2019, including 83 CD patients and 94 patients without CD. Initial control of symptomatic perianal infection with a seton and subsequent healing and reintervention rates were compared between the three postseton management strategies. RESULTS: A total of 177 patients, 61% male and 83.1% with complex fistulas, were followed for a median of 23 months (interquartile range 11-40 months). Immunomodulatory treatment was used in 90.4% of CD patients after seton placement. Good initial control of perianal infection was achieved with a seton in CD and non-CD patients, at 92.9% and 96.7%, respectively (p = 0.11). Overall fistula healing or control for CD and non-CD patients was, respectively, 64% and 86% (p = 0.1) after curative surgery, 49% and 71% after seton removal (p = 0.21) and 58% and 50% with long-term seton placement (p = 0.72). Overall reintervention for recurrence was 83% in CD versus 53.1% in non-CD patients during the follow-up period (p = 0.002). CONCLUSION: Definitive surgery was possible in only a minority of CD patients. Long-term seton management was an effective option in patients with CD with acceptable improvement and recurrence rates.

Trends in the Incidence of Young-Onset Colorectal Cancer With a Focus on Years Approaching Screening Age: A Population-Based Longitudinal Study.

BACKGROUND: With recent evidence for the increasing risk of young-onset colorectal cancer (yCRC), we had the objective to evaluate the incidence of yCRC in 1-year age increments, particularly focusing around the screening age of 50 years. METHODS: We conducted a longitudinal study using linked administrative health databases in British Columbia, Canada, including a provincial cancer registry, inpatient and outpatient visits, and vital statistics from January 1, 1986, to December 31, 2016. We calculated incidence rates per 100 000 at every age from 20 to 60 years and estimated annual percent change in incidence (APCi) of yCRC using joinpoint regression analysis. RESULTS: We identified 3614 individuals with yCRC (49.9% women). The incidence of CRC steadily increased from 20 to 60 years, with a marked increase from 49 to 50 years (incidence rate ratio = 1.19, 95% confidence interval [CI] = 1.04 to 1.34). Furthermore, there was a trend of increased incidence of yCRC among women (APCi = 0.79%, 95% CI = 0.22% to 1.36%) and men (APCi = 2.17%, 95% CI = 1.59% to 2.76%). Analyses stratified by age yielded APCis of 2.49% (95% CI = 1.36% to 3.63%) and 0.12% (95% CI = -0.54% to 0.79%) for women aged 30-39 years and 40-49 years, respectively, and 2.97% (95% CI = 1.65% to 4.31%) and 1.86% (95% CI = 1.19% to 2.53%) for men. CONCLUSIONS: Our findings indicate a steady increase over 1-year age increments in the risk of yCRC during the years approaching and beyond screening age. These findings highlight the need to raise awareness as well as continue discussions regarding considerations of lowering the screening age.

The impact of laparoscopic technique on the rate of perineal hernia after abdominoperineal resection of the rectum.

AIM: To determine the impact of surgical technique on the incidence of perineal hernia after abdominoperineal resection (APR). METHODS: A retrospective analysis was performed on patients who underwent APR between May 2007 and March 2018 at our institution using our prospectively maintained Colorectal Cancer Database. Demographic and clinical parameters were compared between the open APR (OAPR) and laparoscopic APR (LAPR) groups using Student's t test, chi-squared, or Fisher's exact test. Putative risk factors were then analyzed using a Cox proportional hazard model with perineal hernia as the outcome. RESULTS: The study included 261 patients (191 OAPR and 70 LAPR). Intraoperative blood loss (596.0 ± 633.4 vs. 307.0 ± 307.2 mL, p < 0.001), duration of OR (249.6 ± 115.6 vs. 212.6 ± 75.1 min, p = 0.004), and length of stay (15.6 ± 18.0 vs. 10.4 ± 12.6 days, p = 0.031) were all greater for OAPR than LAPR patients, but wound complications other than hernia did not differ significantly. Perineal hernia was observed in 2.1% of OAPR and 12.9% of LAPR patients. In multivariable analysis, significant risk factors for perineal hernia were age, laparoscopic technique, and closure of the perineal wound with myocutaneous flap (HR 1.08, 11.13, and 31.51, respectively, all p < 0.05). CONCLUSIONS: LAPR, although associated with less blood loss and shorter length of hospital stay than OAPR, was a significant risk factor for perineal hernia.