Garfinkle, Richard

Introduction With the rapidly changing landscape of rectal cancer treatment, it is becoming increasingly challenging for clinicians to interpret and synthesise the vast amount of high-quality evidence being generated. A core outcome set (COS) for clinical trials in rectal cancer would help address issues surrounding outcome selection and reporting. The purpose of this research project is to develop a COS to be used in research comparing different treatment paradigms in the management of rectal cancer. Methods and analysis This will be a mixed-methods project, including a systematic review, semi-structured interviews and a Delphi consensus process. The project was designed in accordance with the COMET (Core Outcome Measures in Effectiveness Trials) Handbook, which provides a framework for COS development based on existing evidence. A multidisciplinary Study Advisory Group, composed of rectal cancer providers, methodologists and patients, will oversee the project. A systematic review will be performed to identify an inclusive list of outcomes reported by researchers in previous rectal cancer trials. Outcomes will be collapsed into various core areas and domains according to the OMERACT Filter V.2.0. Semi-structured interviews with rectal cancer survivors and their partners/caregivers will help identify additional patient-centric outcomes not captured in the systematic review. Finally, after a final list of outcomes is generated, patients and healthcare professionals will be invited to participate in a Delphi process to develop the final COS. Ethics and dissemination The study has received full approval with the Research Ethics Committee at the Integrated Health and Social Services Network for West-Central Montreal (health network responsible for the Jewish General Hospital) (REC: 2025-4377) and the Institutional Review Board of the Mount Sinai School of Medicine (IRB: STUDY-25-00515). The results of this study will be presented at national and international meetings and a manuscript will be submitted for publication in a high-impact surgery and/or oncology peer-reviewed journal. Trial registration number The study was registered in the COMET database in December 2023 ( https://www.comet-initiative.org/Studies/Details/2941 ). The full systematic review protocol, along with the search strategy and inclusion/exclusion criteria, was registered online in September 2023 (researchregistry.com; reviewregistry1705).

BACKGROUND: Pelvic exenteration is the treatment of choice for selected patients with locally advanced primary and recurrent rectal cancer. Involvement of major pelvic neurovascular structures and bone was historically considered a contraindication due to unacceptably high rates of morbidity and low R0 resection rates. OBJECTIVE: To compare the outcomes of these “high-complexity” exenterative resections to those of “conventional” pelvic exenteration. DESIGN: International multicenter retrospective cohort study. SETTINGS: Sixteen specialized exenteration centers. PATIENTS: Those who underwent total pelvic exenteration for locally advanced primary and recurrent rectal cancer between 2018 and 2023 at participating centers. MAIN OUTCOME MEASURES: Perioperative resource utilization, morbidity, mortality, and R0 resection rates were reported. RESULTS: Seven hundred sixty-three patients underwent total pelvic exenteration, of whom 478 (63%) and 285 (37%) required conventional and high-complexity procedures, respectively. High-complexity pelvic exenteration was associated with longer operating time (600 vs 480 minutes, p < 0.001 for locally advanced primary rectal cancer, 623 vs 480 minutes, p < 0.001 for locally recurrent rectal cancer), intensive care stay (2 vs 1 day, p < 0.001 and 3 vs 1 day, p < 0.001), hospital stay (19 vs 15 days, p = 0.008 and 23 vs 15 days, p < 0.001), and higher blood loss (2000 vs 1236 mL, p < 0.001 and 3000 vs 1600 mL, p < 0.001). Morbidity and mortality outcomes and R0 resection rates were similar between the groups. LIMITATIONS: Generalizability of findings outside of expert units. CONCLUSIONS: High-complexity pelvic exenteration for the treatment of rectal cancer is associated with similar morbidity, mortality, and R0 resection rates, but it has a significantly higher operative time, blood loss, and hospital resource utilization compared to conventional pelvic exenteration. In high-volume, specialized centers, these techniques are considered the standard of care for appropriately selected patients with tumors that involve major pelvic bone or neurovascular structures. See Video Abstract . EXENTERACIÓN PÉLVICA TOTAL CONVENCIONAL FRENTE A EXENTERACIÓN PÉLVICA TOTAL DE ALTA COMPLEJIDAD PARA EL CÁNCER RECTAL LOCALMENTE AVANZADO Y LOCALMENTE RECURRENTE: UN ESTUDIO MULTICÉNTRICO INTERNACIONAL ANTECEDENTES: La exenteración pélvica es el tratamiento de elección para determinados pacientes con cáncer rectal primario y recurrente localmente avanzado. La afectación de las principales estructuras neurovasculares y óseas pélvicas se consideraba históricamente una contraindicación debido a las tasas inaceptablemente altas de morbilidad y a las bajas tasas de resección R0. OBJETIVO: Comparar los resultados de estas resecciones exenteración «de alta complejidad» con los de la exenteración pélvica «convencional». DISEÑO: Estudio de cohorte retrospectivo multicéntrico internacional. ENTORNOS: Dieciséis centros especializados en exenteración. PACIENTES: Aquellos que se sometieron a una exenteración pélvica total por cáncer rectal primario y recurrente localmente avanzado entre 2018 y 2023 en los centros participantes. PRINCIPALES MEDIDAS DE RESULTADOS: Se informaron la utilización de recursos perioperatorios, la morbilidad, la mortalidad y las tasas de resección R0. RESULTADOS: 763 pacientes se sometieron a una exenteración pélvica total, de los cuales 478 (63 %) y 285 pacientes (37 %) requirieron procedimientos convencionales y de alta complejidad, respectivamente. La exenteración pélvica de alta complejidad se asoció con un tiempo quirúrgico más prolongado (600 frente a 480 minutos, p < 0,001 para el cáncer rectal primario localmente avanzado, 623 frente a 480 minutos, p < 0,001 para el cáncer rectal localmente recurrente), estancia en cuidados intensivos (2 frente a 1 día, p < 0,001 y 3 frente a 1 día, p < 0,001), estancia hospitalaria (19 frente a 15 días, p = 0,008 y 23 frente a 15 días, p < 0,001) y mayor pérdida de sangre (2000 frente a 1236 ml, p < 0,001 y 3000 frente a 1600 ml, p < 0,001). Los resultados de morbilidad y mortalidad, así como las tasas de resección R0, fueron similares entre los grupos. LIMITACIONES: Generalización de los resultados fuera de las unidades especializadas CONCLUSIONES: La exenteración pélvica de alta complejidad para el tratamiento del cáncer de recto se asocia con tasas similares de morbilidad, mortalidad y resección R0, pero con un tiempo quirúrgico, una pérdida de sangre y una utilización de recursos hospitalarios significativamente mayores en comparación con la exenteración pélvica convencional. En centros especializados con un gran volumen de casos, estas técnicas se consideran el tratamiento estándar para pacientes adecuadamente seleccionados con tumores que afectan a los huesos pélvicos principales o a las estructuras neurovasculares. ( AI-generated translation )

Postoperative bowel dysfunction following restorative proctectomy, commonly referred to as Low Anterior Resection Syndrome (LARS), is a common long term sequela of rectal cancer treatment. While many of the established risk factors for LARS are non-modifiable, others may be well within the surgeon’s control. Several pre-, intra-, and postoperative decisions may have a significant impact on postoperative bowel function. Some of these factors include the extent of surgical resection, surgical approach, choice of anastomotic reconstruction, and use of fecal diversion. This review article summarizes the available evidence regarding how surgical decision-making can affect postoperative bowel function.

Objective: To establish globally applicable benchmark outcomes for pelvic exenteration (PE) in patients with locally advanced primary rectal cancer (LARC) and locally recurrent rectal cancer (LRRC), using outcomes achieved at highly specialised centres. Background: PE is established as the standard of care for selected patients with LARC and LRRC. There are currently no available benchmarks against which surgical performance in PE can be compared for audit and quality improvement. Methods: This international multicentre retrospective cohort study included patients undergoing PE for LARC or LRRC at 16 highly experienced centres between 2018 and 2023. Ten outcome benchmarks were established in a lower-risk subgroup. Benchmarks were defined by the 75th percentile of the results achieved at the individual centres. Results: Seven hundred sixty-three patients underwent PE, of which 464 patients (61%) had LARCs and 299 (39%) had LRRCs. Five hundred forty-four patients (71%) who met predefined lower-risk criteria formed the benchmark cohort. For patients with LARC, the calculated benchmark threshold for major complication rate was ≤44%; Comprehensive Complication Index: ≤30.2; 30-day mortality rate: 0%; 90-day mortality rate: ≤4.3%; R0 resection rate: ≥79%. For patients with LRRC, the calculated benchmark threshold for major complication rate was ≤53%; Comprehensive Complication Index: ≤34.1; 30-day mortality rate: 0%; 90-day mortality rate: ≤6%; R0 resection rate: ≥77%. Conclusions: The reported benchmarks for PE in patients with LARC and LRRC represent the best available care for this patient group globally and can be used for rigorous assessment of surgical quality and to facilitate quality improvement initiatives at international exenteration centres.