Imaging in pelvic exenteration-a multidisciplinary practice guide from the ESGAR-SAR-ESUR-PelvEx collaborative group.

Pelvic exenteration (PE) is a radical surgical approach designed for the curative treatment of advanced pelvic malignancies, requiring en-bloc resection of multiple pelvic organs. While the procedure is radical, it has shown promise in enhancing long-term survival and is now comparable in surgical mortality to elective resections for primary pelvic cancers. Imaging plays a crucial role in preoperative planning, with MRI, CT, and PET/CT being pivotal in assessing the extent of cancer and formulating a surgical roadmap. This paper presents clinical practice guidelines for imaging in the context of PE, developed jointly by ESGAR, SAR, ESUR, and the PelvEx Collaborative. These guidelines aim to standardize imaging protocols and reporting to improve the preoperative assessment and facilitate decision-making in the multidisciplinary treatment of pelvic cancers. Our recommendations underscore the importance of a multidisciplinary approach and the need for clear and precise imaging reports to optimize patient care. CLINICAL RELEVANCE STATEMENT: Our recommendations underscore the importance of a multidisciplinary approach and the need for clear and precise imaging reports to optimize patient care. KEY POINTS: MRI is mandatory for local staging in pelvic exenteration. Structured reporting (using the template provided in this guide) is recommended. Multidisciplinary review of imaging is critical for surgical planning.

Rectovaginal Fistula: What Is the Role of Martius Flap and Gracilis Muscle Interposition in the Therapeutic Strategy?

BACKGROUND: Although numerous treatments exist for the management of rectovaginal fistula, none has demonstrated its superiority. The role of diverting stoma remains controversial. A few series include Martius flap in the armamentarium. OBJECTIVE: Determine the role of gracilis muscle interposition and Martius flap in the surgical management of rectovaginal fistula. DESIGN: Retrospective cohort study of a pooled prospectively maintained database from 3 centers. PATIENTS: All consecutive eligible patients with rectovaginal fistula undergoing Martius flap and gracilis muscle interposition were included from 2001 to 2022. MAIN OUTCOME MEASURES: Success was defined by the absence of stoma and rectovaginal fistula. RESULTS: Sixty-two patients were included with 55 Martius flap and 24 gracilis muscle interposition performed after failures of 164 initial procedures. Total length of stay was longer for gracilis muscle interposition by 2 days ( p = 0.01) without a significant difference in severe morbidity (20% vs 12%, p = 0.53). Twenty-seven percent of the Martius flap interpositions were performed without a stoma, which did not have an impact on overall morbidity ( p = 0.763). Per patient immediate success rates were not significantly different between groups (35% vs 31%, p > 0.99). The success of gracilis muscle interposition after the failure of the Martius flap was not significantly different from an initial gracilis muscle interposition ( p > 0.99). After simple perineal procedures, the immediate success rate rose to 49.4% (49% vs 50%, p > 0.99). After a median follow-up of 23 months, no significant difference was detected in success rate between the 2 procedures (69% vs 69%, p > 0.99). Smoking was the only negative predictive factor ( p = 0.02). LIMITATIONS: By its retrospective nature, this study is limited in its comparison. CONCLUSIONS: This novel comparison between Martius flap and gracilis muscle interposition suggests that Martius flap presents several advantages, including shorter length of stay, similar morbidity, and similar success rate. Proximal diversion via a stoma for Martius flap does not appear mandatory. Gracilis muscle interposition could be reserved as a salvage procedure after Martius flap failure. See Video Abstract . FSTULA RECTOVAGINAL CUL ES EL ROL DEL COLGAJO DE MARTIUS Y LA INTERPOSICIN DEL MSCULO GRACILIS EN LA ESTRATEGIA TERAPUTICA: ANTECEDENTES:Si bien existen numerosos tratamientos para el manejo de la fistula rectovaginal, ninguno ha demostrado su superioridad. El papel del estoma de derivación sigue siendo controvertido. Pocas series incluyen colgajo de Martius en el armamento.OBJETIVO:Determinar el rol de la interposición del músculo gracilis y del colgajo de Martius, en el manejo quirúrgico de la fístula rectovaginal.DISEÑO:Estudio de cohorte retrospectivo de una base de datos mantenida prospectivamente en 3 centros.AJUSTES/PACIENTES:Se incluyeron todos los pacientes elegibles consecutivos con fistula rectovaginal sometidos a colgajo de Martius y la interposición del músculo gracilis desde 2001 hasta 2022.RESULTADOS PRINCIPALES:El éxito se definió por la ausencia de estoma y fistula rectovaginal.RESULTADOS:Se incluyeron 62 pacientes con 55 colgajo de Martius y 24 con interposición del músculo gracilis realizados después de fracasos de 164 procedimientos iniciales. La duración total de la estancia hospitalaria fue dos días más larga para la interposición del músculo gracilis ( p = 0,01) sin una diferencia significativa en la morbilidad grave (20% frente a 12%, p = 0,53). El 27% de los colgajos de Martius se realizaron sin estoma, sin impacto en la morbilidad global ( p = 0,763). Las tasas de éxito inmediato por paciente no fueron significativamente diferentes entre los grupos (35% vs. 31%, p = 1,0). El éxito de la interposición del músculo gracilis después del fracaso del colgajo de Martius no fue significativamente diferente de una interposición del músculo gracilis inicial (p = 1,0). La tasa de éxito inmediato aumentó al 49,4% (49% frente a 50%, p = 1,0) después de procedimientos perineales simples. Después de una mediana de seguimiento de 23 meses, no se detectaron diferencias significativas en la tasa de éxito entre los dos procedimientos (69 % frente a 69 %, p = 1,0). El tabaquismo fue el único factor predictivo negativo ( p = 0,02).LIMITACIONES:Por su naturaleza retrospectiva, este estudio tiene limitaciones en su comparación.CONCLUSIÓN:Esta novedosa comparación entre colgajo de Martius y la interposición del músculo gracilis sugiere que el colgajo de Martius presenta varias ventajas, incluida una estancia prolongada más corta, una morbilidad similar y un éxito. La derivación proximal a través de un estoma para el colgajo de Martius no parece obligatoria. La interposición del músculo gracilis podría reservarse como procedimiento de rescate después de una falla de colgajo de Martius. (Traducción-Dr. Aurian Garcia Gonzalez ).

Local Regrowth and the Risk of Distant Metastases Among Patients Undergoing Watch-and-Wait for Rectal Cancer: What Is the Best Control Group? Multicenter Retrospective Study.

BACKGROUND: A proportion of rectal cancer patients who achieve a clinical complete response may develop local regrowth. Although salvage appears to provide appropriate local control, the risk of distant metastases is less known. OBJECTIVE: To compare the risk of distant metastases between patients who achieve a clinical complete response (watch-and-wait strategy) and subsequent local regrowth and patients managed by surgery after chemoradiation. DESIGN: Retrospective multicenter cohort study. SETTINGS: This study used data of patients from 3 institutions who were treated between 1993 and 2019. PATIENTS: Patients with initial clinical complete response (after neoadjuvant therapy) followed by local regrowth and patients with near-complete pathological response (≤10%) after straightforward surgery after chemoradiation were included. MAIN OUTCOME MEASURES: Univariate and multivariate analyses were performed to identify risk factors for distant metastases. Kaplan-Meier curves were created (log-rank test) to compare survival outcomes. Analyses were performed using time zero as last day of radiation therapy or as date of salvage resection in the local regrowth group. RESULTS: Twenty-one of 79 patients with local regrowth developed distant metastases, whereas only 10 of 74 after upfront total mesorectal excision following neoadjuvant chemoradiation therapy ( p = 0.04). Local regrowth and final pathology (ypT3-4) were the only independent risk factors associated with distant metastases. When using date of salvage resection as time zero, distant metastases-free survival rates were significantly inferior for patients with local regrowth (70% vs 86%; p = 0.01). LIMITATIONS: Small number of patients, many neoadjuvant therapies, and selection bias. CONCLUSIONS: Patients undergoing watch-and-wait strategy who develop local regrowth are at higher risk for development of distant metastases compared to patients with near-complete pathological response managed by upfront surgery after chemoradiation. See Video Abstract. NUEVO CRECIMIENTO LOCAL Y EL RIESGO DE METSTASIS A DISTANCIA ENTRE PACIENTES SOMETIDOS A OBSERVACIN Y ESPERA POR CNCER DE RECTO CUL ES EL MEJOR GRUPO DE CONTROL ESTUDIO RETROSPECTIVO MUTICNTRICO: ANTECEDENTES:Una proporción de pacientes que logran una respuesta clínica completa pueden desarrollar un nuevo crecimiento local. Si bien el rescate parece proporcionar un control local apropiado, el riesgo de metástasis a distancia es menos conocido.OBJETIVO:Comparar el riesgo de metástasis a distancia entre los pacientes que logran una respuesta clínica completa (estrategia de observación y espera) y el nuevo crecimiento local posterior con los pacientes tratados con cirugía después de la quimiorradiación.DISEÑO:Estudio de cohorte multicéntrico retrospectivo.CONFIGURACIÓN:Este estudio utilizó datos de pacientes de 3 instituciones que fueron tratados entre 1993 y 2019.PACIENTES:Pacientes con respuesta clínica completa inicial (después de la terapia neoadyuvante) seguida de crecimiento local nuevo y pacientes con respuesta patológica casi completa (≤10 %) después de cirugía directa después de quimiorradiación.PRINCIPALES MEDIDAS DE RESULTADO:Se realizó un análisis univariante/multivariante para identificar los factores de riesgo de metástasis a distancia. Se crearon curvas de Kaplan-Meier (prueba de rango logarítmico) para comparar los resultados de supervivencia. El análisis se realizó utilizando el tiempo cero como último día de radioterapia (1) o como fecha de resección de rescate (2) en el grupo de recrecimiento local.RESULTADOS:Veintiuno de 79 pacientes con recrecimiento local desarrollaron metástasis a distancia, mientras que solo 10 de 74 después de una cirugía sencilla (p = 0,04). El recrecimiento local y la patología final (ypT3-4) fueron los únicos factores de riesgo independientes asociados con las metástasis a distancia. Cuando se utilizó la fecha de la resección de rescate como tiempo cero, las tasas de supervivencia sin metástasis a distancia fueron significativamente inferiores para los pacientes con recrecimiento local (70 frente a 86 %; p = 0,01).LIMITACIONES:Pequeño número de pacientes, muchas terapias neoadyuvantes, sesgo de selección.CONCLUSIONES:Los pacientes sometidos a observación y espera que desarrollan un nuevo crecimiento local tienen un mayor riesgo de desarrollar metástasis a distancia en comparación con los pacientes con una respuesta patológica casi completa manejados con cirugía por adelantado después de la quimiorradiación. (Traducción-Dr. Xavier Delgadillo ).

Feasibility of a tailored operative strategy from organ preservation to pelvic exenteration for cT4 rectal cancer depending on neoadjuvant response.

PURPOSE: Improvements in neoadjuvant therapy for locally advanced cT4 rectal cancer have led to improved tumour response and thus a variety of suitable management strategies. The aim of this study was to report management and outcomes of patients with cT4 rectal cancer undergoing a spectrum of treatment strategies from organ preservation (OP) to pelvic exenteration (PE). METHODS: Patients who underwent elective treatment for cT4 rectal cancer between 2016 and 2021 were included. All patients were treated with curative intent. Surgical management was adapted to tumour response. Kaplan-Meier curves were generated to compare 3-year overall survival (3y-OS), local recurrence (3y-LR) and distant metastases (3y-DM) between different strategies. RESULTS: Among 152 patients included, 13 (8%) underwent OP, 71 (47%) TME and 68 (45%) APR/PE. The median follow-up was 31.3 months. Patients undergoing OP had a lower tumour pretreatment (p < 0.001). Compared to patients with TME, those with APR/PE had a higher rate of ypT4 (p = 0.001) with a lower R0 rate (p = 0.044). The 3y-OS and 3y-DM were 78% and 15.1%, respectively, without significant differences. The 3y-LR was 6.6%, and patients with OP had a significantly worse 3y-local regrowth compared to 3y-LR in patients with TME and APR/PE (30.2% vs. 5.4% vs. 2%, p = 0.008). CONCLUSION: cT4 tumours may be suitable for the full spectrum of rectal cancer management from organ preservation to pelvic exenteration depending on tumour response to neoadjuvant therapy. However, careful attention is required in OP as local regrowth in up to 30% of cases reinforces the need for sustained active surveillance in Watch&Wait programmes.

TAilored SToma policY after TME for rectal cancer: The TASTY approach.

AIM: Diverting stomas are routinely used in restorative surgery following total mesorectal exicision (TME) for rectal cancer to mitigate the clinical risks of anastomotic leakage (AL). However, routine diverting stomas are associated with their own complication profile and may not be required in all patients. A tailored approach based on personalized risk of AL and selective use of diverting stoma may be more appropriate. The aim of the TAilored SToma policY (TASTY) project was to design and pilot a standardized, tailored approach to diverting stoma in low rectal cancer. METHOD: A mixed-methods approach was employed. Phase I externally validated the anastomotic failure observed risk score (AFORS). We compared the observed rate of AL in our cohort to the theoretical, predicted risk of the AFORS score. To identify the subset of patients who would benefit from early closure of the diverting stoma using C-reactive protein (CRP) we calculated the Youden index. Phase II designed the TASTY approach based on the results of Phase I. This was evaluated within a second prospective cohort study in patients undergoing TME for rectal cancer between April 2018 and April 2020. RESULTS: A total of 80 patients undergoing TME surgery for rectal cancer between 2016 and 2018 participated in the external validation of the AFORS score. The overall observed AL rate in this cohort of patients was 17.5% (n = 14). There was a positive correlation between the predicted and observed rates of AL using the AFORS score. Using ROC curves, we calculated a CRP cutoff value of 115 mg/L on postoperative day 2 for AL with a sensitivity of 86% and a negative predictive value of 96%. The TASTY approach was designed to allocate patients with a low risk AFORS score to primary anastomosis with no diverting stoma and high risk AFORS score patients to a diverting stoma, with early closure at 8-14 days, if CRP values and postoperative CT were satisfactory. The TASTY approach was piloted in 122 patients, 48 (39%) were identified as low risk (AFORS score 0-1) and 74 (61%) were considered as high risk (AFORS score 2-6). The AL rate was 10% in the low-risk cohort of patient compared to 23% in the high-risk cohort of patients, p = 0.078 The grade of Clavien-Dindo morbidity was equivalent. The incidence of major LARS was lowest in the no stoma cohort at 3 months (p = 0.014). CONCLUSION: This study demonstrates the feasibility and safety of employing a selective approach to diverting stoma in patients with a low anastomosis following TME surgery for rectal cancer.

Combined Robotic Transanal Transection Single-Stapled Technique in Ultralow Rectal Endometriosis Involvement Associated With Parametrial and Vaginal Infiltration.

OBJECTIVE: To describe a combined robotic and transanal technique used to treat ultralow rectal endometriosis in a 36-year-old patient with multiple pelvic compartments, which was responsible for infertility, dyspareunia, left sciatic pain, and severe dyschezia. DESIGN: Surgical video article. SETTING: The achievement of a perfect bowel anastomosis in patients with low rectal endometriosis could be challenging owing to technical and anatomic limitations [1]. By allowing a right angle rectotomy with a single-stapled anastomosis, the transanal transection single-stapled technique overcomes these technical difficulties ensuring a good-quality anastomosis with an easier correction of postoperative anastomotic leakage when it occurs [2,3]. INTERVENTIONS: The surgery starts by splitting the nodule in 3 components according to different anatomic structures involved (parametrium, vagina, and rectum). Parametrial and vaginal fragments are excised as previously described (Supplemental Videos 1) [4]. The rectal involvement is approached following several steps: isolation and cut of inferior mesenteric vessels (inferior mesenteric artery and inferior mesenteric vein) and left colic artery to obtain a proper colon mobilization; transanal rectotomy immediately below the lower limit of the nodule; extraction of the specimen through the anus (Supplemental Videos 2); proximal bowel segment transection 1 cm above the upper limit of the nodule; introduction of circular stapler anvil into the sigmoid colon; placement of 2 purse string to secure the anvil and at distal rectal cuff, respectively; connection of the anvil to the shoulder of circular stapler; stapler closing and firing with coloanal anastomosis formation; stapled line reinforcement by stitching; and integrity anastomosis test (Supplemental Videos 3). No preventive diverting stoma was performed in accordance with our policy [5]. CONCLUSIONS: Although no data are yet available in patients with endometriosis, the use of transanal transection single-stapled technique may be an interesting approach in patients with very low rectal endometriosis involvement.

An International Multicenter Prospective Study Evaluating the Long-term Oncological Impact of Adjuvant Chemotherapy in ypN+ Rectal Cancer.

OBJECTIVE: To assess the oncological benefit of adjuvant chemotherapy (AC) in node positive (ypN+) rectal cancer after neoadjuvant chemoradiotherapy and radical surgery. BACKGROUND: The evidence for AC after total mesorectal excision for locally advanced rectal cancer is conflicting and the net survival benefit is debated. METHODS: An international multicenter comparative cohort study was performed comparing oncological outcomes in tertiary rectal cancer centers from the Netherlands and France. Patients with locally advanced rectal cancer treated with neoadjuvant chemoradiotherapy followed by total mesorectal excision surgery and with positive lymph nodes on histologic examination (ypN+) were included for analysis. Kaplan-Meier curves were generated to compare disease-free (DFS) and overall survival in AC and non-AC groups. RESULTS: Of 1265 patients screened, a total of 239 rectal cancer patients with ypN+ disease were included. Demographic and clinical characteristics were similar in both groups. Higher systemic recurrence rates were observed in the non-AC group compared with those who received AC [32.0% (n=40) vs 17.5% (n=11), respectively, P =0.034]. DFS at 1 and 5 years postoperatively were significantly better in the AC group (92% vs 80% at 1 year; 72% vs 51% at 5 years, P =0.024), whereas no difference in overall survival was observed. CONCLUSIONS: In this multicenter comparative cohort study, we identified an oncological benefit of AC in both systemic recurrence and DFS in ypN+ rectal cancer patients. From this data, systemic chemotherapy continues to confer oncological benefit in locally advanced ypN+ rectal cancer.

Stoma-free Survival After Rectal Cancer Resection With Anastomotic Leakage: Development and Validation of a Prediction Model in a Large International Cohort.

OBJECTIVE: To develop and validate a prediction model (STOMA score) for 1-year stoma-free survival in patients with rectal cancer (RC) with anastomotic leakage (AL). BACKGROUND: AL after RC resection often results in a permanent stoma. METHODS: This international retrospective cohort study (TENTACLE-Rectum) encompassed 216 participating centres and included patients who developed AL after RC surgery between 2014 and 2018. Clinically relevant predictors for 1-year stoma-free survival were included in uni and multivariable logistic regression models. The STOMA score was developed and internally validated in a cohort of patients operated between 2014 and 2017, with subsequent temporal validation in a 2018 cohort. The discriminative power and calibration of the models' performance were evaluated. RESULTS: This study included 2499 patients with AL, 1954 in the development cohort and 545 in the validation cohort. Baseline characteristics were comparable. One-year stoma-free survival was 45.0% in the development cohort and 43.7% in the validation cohort. The following predictors were included in the STOMA score: sex, age, American Society of Anestesiologist classification, body mass index, clinical M-disease, neoadjuvant therapy, abdominal and transanal approach, primary defunctioning stoma, multivisceral resection, clinical setting in which AL was diagnosed, postoperative day of AL diagnosis, abdominal contamination, anastomotic defect circumference, bowel wall ischemia, anastomotic fistula, retraction, and reactivation leakage. The STOMA score showed good discrimination and calibration (c-index: 0.71, 95% CI: 0.66-0.76). CONCLUSIONS: The STOMA score consists of 18 clinically relevant factors and estimates the individual risk for 1-year stoma-free survival in patients with AL after RC surgery, which may improve patient counseling and give guidance when analyzing the efficacy of different treatment strategies in future studies.

Is Delaying a Coloanal Anastomosis the Ideal Solution for Rectal Surgery?: Analysis of a Multicentric Cohort of 564 Patients From the GRECCAR.

OBJECTIVES: To assess the specific results of delayed coloanal anastomosis (DCAA) in light of its 2 main indications. BACKGROUND: DCAA can be proposed either immediately after a low anterior resection (primary DCAA) or after the failure of a primary pelvic surgery as a salvage procedure (salvage DCAA). METHODS: All patients who underwent DCAA intervention at 30 GRECCAR-affiliated hospitals between 2010 and 2021 were retrospectively included. RESULTS: Five hundred sixty-four patients (male: 63%; median age: 62 years; interquartile range: 53-69) underwent a DCAA: 66% for primary DCAA and 34% for salvage DCAA. Overall morbidity, major morbidity, and mortality were 57%, 30%, and 1.1%, respectively, without any significant differences between primary DCAA and salvage DCAA ( P = 0.933; P = 0.238, and P = 0.410, respectively). Anastomotic leakage was more frequent after salvage DCAA (23%) than after primary DCAA (15%), ( P = 0.016).Fifty-five patients (10%) developed necrosis of the intra-abdominal colon. In multivariate analysis, intra-abdominal colon necrosis was significantly associated with male sex [odds ratio (OR) = 2.67 95% CI: 1.22-6.49; P = 0.020], body mass index >25 (OR = 2.78 95% CI: 1.37-6.00; P = 0.006), and peripheral artery disease (OR = 4.68 95% CI: 1.12-19.1; P = 0.030). The occurrence of this complication was similar between primary DCAA (11%) and salvage DCAA (8%), ( P = 0.289).Preservation of bowel continuity was reached 3 years after DCAA in 74% of the cohort (primary DCAA: 77% vs salvage DCAA: 68%, P = 0.031). Among patients with a DCAA mannered without diverting stoma, 75% (301/403) have never required a stoma at the last follow-up. CONCLUSIONS: DCAA makes it possible to definitively avoid a stoma in 75% of patients when mannered initially without a stoma and to save bowel continuity in 68% of the patients in the setting of failure of primary pelvic surgery.

Stoma-free survival after anastomotic leak following rectal cancer resection: worldwide cohort of 2470 patients.

BACKGROUND: The optimal treatment of anastomotic leak after rectal cancer resection is unclear. This worldwide cohort study aimed to provide an overview of four treatment strategies applied. METHODS: Patients from 216 centres and 45 countries with anastomotic leak after rectal cancer resection between 2014 and 2018 were included. Treatment was categorized as salvage surgery, faecal diversion with passive or active (vacuum) drainage, and no primary/secondary faecal diversion. The primary outcome was 1-year stoma-free survival. In addition, passive and active drainage were compared using propensity score matching (2 : 1). RESULTS: Of 2470 evaluable patients, 388 (16.0 per cent) underwent salvage surgery, 1524 (62.0 per cent) passive drainage, 278 (11.0 per cent) active drainage, and 280 (11.0 per cent) had no faecal diversion. One-year stoma-free survival rates were 13.7, 48.3, 48.2, and 65.4 per cent respectively. Propensity score matching resulted in 556 patients with passive and 278 with active drainage. There was no statistically significant difference between these groups in 1-year stoma-free survival (OR 0.95, 95 per cent c.i. 0.66 to 1.33), with a risk difference of -1.1 (95 per cent c.i. -9.0 to 7.0) per cent. After active drainage, more patients required secondary salvage surgery (OR 2.32, 1.49 to 3.59), prolonged hospital admission (an additional 6 (95 per cent c.i. 2 to 10) days), and ICU admission (OR 1.41, 1.02 to 1.94). Mean duration of leak healing did not differ significantly (an additional 12 (-28 to 52) days). CONCLUSION: Primary salvage surgery or omission of faecal diversion likely correspond to the most severe and least severe leaks respectively. In patients with diverted leaks, stoma-free survival did not differ statistically between passive and active drainage, although the increased risk of secondary salvage surgery and ICU admission suggests residual confounding.

The Crying Need for a Better Response Assessment in Rectal Cancer.

OPINION STATEMENT: Since total neoadjuvant treatment achieves almost 30% pathologic complete response, organ preservation has been increasingly debated for good responders after neoadjuvant treatment for patients diagnosed with rectal cancer. Two organ preservation strategies are available: a watch and wait strategy and a local excision strategy including patients with a near clinical complete response. A major issue is the selection of patients according to the initial tumor staging or the response assessment. Despite modern imaging improvement, identifying complete response remains challenging. A better selection could be possible by radiomics analyses, exploiting numerous image features to feed data characterization algorithms. The subsequent step is to include baseline and/or pre-therapeutic MRI, PET-CT, and CT radiomics added to the patients' clinicopathological data, inside machine learning (ML) prediction models, with predictive or prognostic purposes. These models could be further improved by the addition of new biomarkers such as circulating tumor biomarkers, molecular profiling, or pathological immune biomarkers.

IDEAL Stage 2a/b prospective cohort study of transanal transection and single-stapled anastomosis for rectal cancer.

AIM: There are several anastomotic techniques available to facilitate restorative rectal cancer surgery after total mesorectal excision (TME), including double-stapled anastomosis (DST) and handsewn coloanal anastomosis (CAA). However, to date no one technique is superior with regard to anastomotic leakage (AL) or functional outcomes. Transanal transection single-stapled anastomosis (TTSS) aims to overcome some of the technical challenges and offer comparable clinical and functional outcomes to traditional anastomotic techniques. The aim of this study was to explore the role of TTSS in modern rectal cancer surgery and to provide comparative clinical and functional outcome data with DST and CAA. METHOD: A prospective cohort study was undertaken to assess the safety and clinical and patient-reported outcomes associated with the TTSS procedure. All patients undergoing sphincter-preserving surgery for rectal cancer with an anastomosis performed within 6 cm of the anal verge between January 2016 and April 2021 were prospectively enrolled into this study. Clinical and patient-reported outcome data, including low anterior resection syndrome (LARS) assessment, were collected. The primary endpoint was anastomotic leakage within 30 days. RESULTS: A total of 275 patients participated in this study, with 70 (25%) patients undergoing a TTSS, 110 (40%) undergoing a DST and 95 (35%) undergoing a CAA. Patients undergoing a CAA had more distal tumours than those having a TTSS or DST, with a median tumour height of 5, 7 and 9 cm (p < 0.001), respectively. We observed a statistically significant reduction in AL in the TTSS group compared with the DST group, with rates of 8.6% versus 20.9% (p = 0.028). There was no difference in LARS scores between patients undergoing TTSS and DST (p = 0.228), while patients with a CAA had worse LARS scores than TTSS patients (p = 0.002). CONCLUSION: TTSS is a technically safe and feasible anastomotic technique in rectal cancer surgery as an alternative to DST and CAA. Its advantages over DST are a reduced AL rate and, over CAA, improved function. It should therefore be considered as an alternative technique to improve clinical and patient-reported outcomes in restorative rectal cancer surgery.

Robotic-assisted versus conventional laparoscopic approach in patients with large rectal endometriotic nodule: the evaluation of safety and complications.

AIM: The aim was to compare postoperative complications in patients undergoing the excision of a rectal endometriotic nodule over 3 cm by a robotic-assisted versus a conventional laparoscopic approach. METHODS: We conducted a retrospective cohort study evaluating prospectively collected data. The main interventions included rectal shaving, disc excision or colorectal resection. All the surgeries were performed in one endometriosis reference institute. To evaluate factors significantly associated with the risk of anastomosis leakage or fistula and bladder atony, we conducted a multivariate logistic regression model. RESULTS: A total of 548 patients with rectal endometriotic nodule over 3 cm in diameter (#ENZIAN C3) were included in the final analysis. The demography and clinical characteristics of women managed by the robotic-assisted (n = 97) approach were similar to those of patients who underwent conventional laparoscopy (n = 451). The multivariate logistic regression demonstrated that the surgical approach (robotic-assisted vs. laparoscopic) was not associated with the rate of anastomosis leakage or fistula (adjusted odds ratio [aOR] 1.2, 95% confidence interval [CI] 0.3-4.0) and bladder dysfunction (aOR 0.5, 95% CI 0.1-1.8). A rectal nodule located lower than 6 cm from the anal verge was significantly associated with anastomosis leakage (aOR 4.1, 95% CI 1.4-10.8) and bladder atony (aOR 4.3, 95% CI 1.5-12.3). Anastomosis leakage was also associated with smoking (aOR 3.2, 95% CI 1.4-7.4), significant vaginal infiltration (aOR 2.7, 95% CI 1.2-6.7) and excision of nodules involving sacral roots (aOR 5.6, 95% CI 1.7-15.5). CONCLUSION: The robotic-assisted approach was not associated with increased risk of main postoperative complications compared to conventional laparoscopy for the treatment of large rectal endometriotic nodules.

A phase III randomized trial evaluating the quality of life impact of a tailored versus systematic use of defunctioning ileostomy following total mesorectal excision for rectal cancer-GRECCAR 17 trial protocol.

AIM: The systematic use of a defunctioning ileostomy for 2-3 months postoperatively to protect low colorectal anastomosis (<7 cm from the anal verge) has been the standard practice after total mesorectal excision (TME). However, stoma-related complications can occur in 20%-60% of cases, which may lead to prolonged inpatient care, urgent reoperation and long-term definitive stoma. A negative impact on quality of life (QoL) and increased healthcare expenses are also observed. Conversely, it has been reported that patients without a defunctioning stoma or following early stoma closure (days 8-12 after TME) have a better functional outcome than patients with systematic defunctioning stoma in situ for 2-3 months. METHOD: The main objective of this trial is to compare the QoL impact of a tailored versus systematic use of a defunctioning stoma after TME for rectal cancer. The primary outcome is QoL at 12 months postoperatively using the European Organization for. Research and Treatment of Cancer QoL questionnaire QLQ-C30. Among 29 centres of the French GRECCAR network, 200 patients will be recruited over 18 months, with follow-up at 1, 4, 8 and 12 months postoperatively, in an open-label, randomized, two-parallel arm, phase III superiority clinical trial. The experimental arm (arm A) will undergo a tailored use of defunctioning stoma after TME based on a two-step process: (i) to perform or not a defunctioning stoma according to the personalized risk of anastomotic leak (defunctioning stoma only if modified anastomotic failure observed risk score ≥2) and (ii) if a stoma is fashioned, whether to perform an early stoma closure at days 8-12, according to clinical (fever), biochemical (C-reactive protein level on days 2 and 4 postoperatively) and radiological postoperative assessment (CT scan with retrograde contrast enema at days 7-8 postoperatively). The control arm (arm B) will undergo systematic use of a defunctioning stoma for 2-3 months after TME for all patients, in keeping with French national and international guidelines. Secondary outcomes will include comprehensive analysis of functional outcomes (including bowel, urinary and sexual function) again up to 12 months postoperatively and a cost analysis. Regular assessments of anastomotic leak rates in both arms (every 50 randomized patients) will be performed and an independent data monitoring committee will recommend trial cessation if this rate is excessive in arm A compared to arm B. CONCLUSION: The GRECCAR 17 trial is the first randomized trial to assess a tailored, patient-specific approach to decisions regarding defunctioning stoma use and closure after TME according to personalized risk of anastomotic leak. The results of this trial will describe, for the first time, the QoL and morbidity impact of selective use of a defunctioning ileostomy and the potential health economic effect of such an approach.

Comparison between preoperative chemoradiotherapy and lateral pelvic lymph node dissection in clinical T3 low rectal cancer without enlarged lateral lymph nodes.

AIM: The standard strategy for clinical T3 rectal cancer without enlarged lateral lymph nodes is preoperative chemoradiotherapy (CRT) followed by total mesorectal excision (TME) in Western countries and TME with bilateral lateral pelvic lymph node dissection (LPLND) in Japan. This study compared surgical, pathological and oncological results of these two strategies. METHOD: Patients who underwent preoperative CRT followed by TME in France (CRT + TME group) and those who underwent TME with LPLND in Japan (TME + LPLND group) for clinical T3 rectal adenocarcinoma without enlarged lateral lymph nodes from 2010 to 2016 were retrospectively analysed. RESULTS: In total, 439 patients were included in this study. The estimated local recurrence rate (LRR), disease-free survival and overall survival at 5 years post-surgery was 4.9%, 71% and 82% in the CRT + TME group, and 8.6%, 75% and 90% in the TME + LPLND group, respectively. Lateral LRR versus non-lateral LRR was 0.5% versus 4.2% in the CRT + TME group and 1.8% versus 6.2% in the TME + LPLND group. Obturator nerve injury and isolated pelvic abscess were shown only in the TME + LPLND group. Urinary complications were more frequent in the TME + LPLND group than in the CRT + TME group. CONCLUSION: Disease-free survival was not significantly different after TME with LPLND and after CRT followed by TME. LRR was not significantly different after both strategies; however, there was a trend for higher LRR after TME with LPLND than after CRT followed by TME. Obturator nerve injury, isolated lateral pelvic abscess and urinary complications should be noted when TME with LPLND is applied.

Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial.

INTRODUCTION: Low-pressure pneumoperitoneum (LLP) in laparoscopy colorectal surgery (CS) has resulted in reduced hospital stay and lower analgesic consumption. Microsurgery (MS) in CS is a technique that has a significant impact with respect to postoperative pain. The combination of MS plus LLP, known as low-impact laparoscopy (LIL), has never been applied in CS. Therefore, this trial will assess the efficacy of LLP plus MS versus LLP alone in terms of decreasing postoperative pain 24 h after surgery, without taking opioids. METHOD: PAROS II will be a prospective, multicentre, outcome assessor-blinded, randomised controlled phase III clinical trial that compares LLP plus MS versus LLP alone in patients undergoing laparoscopic surgery for colonic or upper rectal cancer or benign pathology. The primary outcome will be the number of patients with postoperative pain 24 h after the surgery, as defined by a visual analogue scale rating ≤3 and without taking opioids. Overall, PAROS II aims to recruit 148 patients for 50% of patients to reach the primary outcome in the LLP plus MS arm, with 80% power and an 5% alpha risk. CONCLUSION: The PAROS II trial will be the first phase III trial to investigate the impact of LIL, including LLP plus MS, in laparoscopic CS. The results may improve the postoperative recovery experience and decrease opioid consumption after laparoscopic CS.

Local excision after neoadjuvant chemoradiotherapy for mid and low rectal cancer: a multicentric French study from the GRECCAR group.

AIM: A complete or subcomplete tumour response (CTR) is observed in 10%-25% of patients with mid/low rectal cancer after neoadjuvant chemoradiotherapy (CRT). The aim of our study was to report a multicentric French experience in local excision (LE) after CRT. METHOD: All patients who underwent LE for mid/low rectal cancer with suspected CTR after CRT, from 2006 to 2019 in seven GRECCAR centres were included. LE was considered adequate if the specimen showed a ypT0/Tis/T1R0 tumour, otherwise, a completion total mesorectal excision (TME) was discussed. Morbi-mortality, functional results and oncological outcomes were studied. RESULTS: A total of 257 patients were included. LE specimens showed 36% ypT0, 4% ypTis and 19% ypT1. Thus, 108 patients (42%) had theoretical indication of completion TME, which was performed in only 42 patients. Overall, 30-day morbidity after LE was 11%, including 2% Clavien-Dindo grade III or IV complications. After completion TME, 47% described major low anterior resection syndrome versus 5% after LE alone (p < 0.001). After a mean follow-up of 4 years (range 2-6 years), the recurrence rate was 11% after LE, 32% after completion TME and 20% in patients for whom completion TME was indicated but not performed (p = 0.021). CONCLUSION: TME remains the gold standard for mid/low rectal cancer after CRT. LE in selected patients is safe for operative and functional, but also oncological, results. However, completion TME was indicated in 42% of patients after LE, highlighting the difficulty of the preoperative diagnosis of CTR after CRT.

International standardization and optimization group for intersphincteric resection (ISOG-ISR): modified Delphi consensus on anatomy, definition, indication, surgical technique, specimen description and functional outcome.

AIM: Intersphincteric resection (ISR) is an oncologically complex operation for very low-lying rectal cancers. Yet, definition, anatomical description, operative indications and operative approaches to ISR are not standardized. The aim of this study was to standardize the definition of ISR by reaching international consensus from the experts in the field. This standardization will allow meaningful comparison in the literature in the future. METHOD: A modified Delphi approach with three rounds of questionnaire was adopted. A total of 29 international experts from 11 countries were recruited for this study. Six domains with a total of 37 statements were examined, including anatomical definition; definition of intersphincteric dissection, intersphincteric resection (ISR) and ultra-low anterior resection (uLAR); indication for ISR; surgical technique of ISR; specimen description of ISR; and functional outcome assessment protocol. RESULTS: Three rounds of questionnaire were performed (response rate 100%, 89.6%, 89.6%). Agreement (≥80%) reached standardization on 36 statements. CONCLUSION: This study provides an international expert consensus-based definition and standardization of ISR. This is the first study standardizing terminology and definition of deep pelvis/anal canal anatomy from a surgical point of view. Intersphincteric dissection, ISR and uLAR were specifically defined for precise surgical description. Indication for ISR was determined by the rectal tumour's maximal radial infiltration (T stage) below the levator ani. A new surgical definition of T3isp was reached by consensus to define T3 low rectal tumours infiltrating the intersphincteric plane. A practical flowchart for surgical indication for uLAR/ISR/abdominoperineal resection was developed. A standardized ISR surgical technique and functional outcome assessment protocol was defined.

Excision of Deep Rectovaginal Endometriosis Nodules with Large Infiltration of Both Rectum and Vagina: What Is a Reasonable Rate of Preventive Stoma? A Comparative Study.

STUDY OBJECTIVE: To compare postoperative complications and rectovaginal fistula rate in women undergoing excision of large rectovaginal endometriosis requiring concomitant excision of rectum and vagina during 2 time periods with differing policies for preventive stoma confection. DESIGN: Retrospective before-and-after comparative cohort study on data prospectively recorded in a database. Patients managed from September 2018 to March 2020 (first period) were compared with those managed from April 2020 to June 2022 (second period). SETTING: Endometriosis Institute. PATIENTS: One hundred sixty-eight patients presenting with deep endometriosis infiltrating the rectum and vagina, with lesions more than 3 cm in diameter during 2 consecutive time periods with differing policies regarding use of preventive stoma. INTERVENTIONS: Rectal disc excision or colorectal resection, concomitantly with large vaginal excision. MEASUREMENTS AND MAIN RESULTS: A total of 87 and 81 women received surgery during the first and the second period, respectively, during which the rate of preventive stoma was, respectively, 32.2% and 8.6%. Deep rectovaginal nodule characteristics were comparable. The mean height (SD) of rectal sutures after disc excision and colorectal resection were, respectively, 6.5 cm (2.3 cm) and 7.2 cm (3.8 cm). Rectovaginal fistula was recorded in 17 patients, corresponding to an overall rate of 10.1%. The rates of rectovaginal fistula in the group of patients with and without preventive stoma, regardless of the period in which surgery was performed, were 11.4% and 9.8%, respectively (p = .76). The rates of fistula recorded during the first and the second period were, respectively, 9.2% and 11.1% (p = .80), and that of overall early main complications were 31% and 29.6% (p = .84). Regression logistic model identified an independent relationship between smoking and rectovaginal fistula (adjusted odds ratio [OR] 3.9, 95% confidence interval [CI] 1.1-14) after adjustment for the period (adjusted OR 1.4, 95% CI 0.4-4.9 related to the second period), stoma confection (adjusted OR 1.8, 95% CI 0.5-7.1 related to stoma confection), robotic surgery (adjusted OR 1.7, 95% CI 0.3-10.1 related to robotic assistance), and type of rectal surgery (adjusted OR 0.4, 95% CI 0.1-1.4 related to disc excision when compared with colorectal resection). CONCLUSION: No statistically significant differences were found concerning risk of rectovaginal fistula in women with rectovaginal endometriosis requiring large rectal and vaginal excision after a decision to no longer routinely perform preventive stoma.

Organ preservation in rectal cancer: review of contemporary management.

BACKGROUND: Organ preservation as a successful management for rectal cancer is an evolving field. Refinement of neoadjuvant therapies and extended interval to response assessment has improved tumour downstaging and cCR rates. METHODS: This was a narrative review of the current evidence for all aspects of organ preservation in rectal cancer management, together with a review of the future direction of this field. RESULTS: Patients can be selected for organ preservation opportunistically, based on an unexpectedly good tumour response, or selectively, based on baseline tumour characteristics that predict organ preservation as a viable treatment strategy. Escalation in oncological therapy and increasing the time interval from completion of neaodjuvant therapy to tumour assessment may further increase tumour downstaging and complete response rates. The addition of local excision to oncological therapy can further improve organ preservation rates. Cancer outcomes in organ preservation are comparable to those of total mesorectal excision, with low regrowth rates reported in patients who achieve a complete response to neoadjuvant therapy. Successful organ preservation aims to achieve non-inferior oncological outcomes together with improved functionality and survivorship. Future research should establish consensus of follow-up protocols, and define criteria for oncological and functional success to facilitate patient-centred decision-making. CONCLUSION: Modern neoadjuvant therapy for rectal cancer and increasing the interval to tumour response increases the number of patients who can be managed successfully with organ preservation in rectal cancer, both as an opportunistic event and as a planned treatment strategy.