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

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

Stenosis of the colorectal anastomosis after surgery for diverticulitis: A national retrospective cohort study.

AIM: The aim of this work was to investigate the association between early postoperative anastomotic leakage or pelvic abscess (AL/PA) and symptomatic anastomotic stenosis (SAS) in patients after surgery for left colonic diverticulitis. METHOD: This is a retrospective study based on a national cohort of diverticulitis surgery patients carried out by the Association Française de Chirurgie. The assessment was performed using path analyses. The database included 7053 patients operated on for colonic diverticulitis, with surgery performed electively or in an emergency, by open access or laparoscopically. Patients were excluded from the study analysis where there was (i) right-sided diverticulitis (the initial database included all consecutive patients operated on for colonic diverticulitis), (ii) no anastomosis was performed during the first procedure or (iii) missing information about stenosis, postoperative abscess or anastomotic leakage. RESULTS: Of the 4441 patients who were included in the final analysis, AL/PA occurred in 327 (4.6%) and SAS occurred in 82 (1.8%). AL/PA was a significant independent factor associated with a risk for occurrence of SAS (OR = 3.41, 95% CI = 1.75-6.66), as was the case for diverting stoma for ≥100 days (OR = 2.77, 95% CI = 1.32-5.82), while central vessel ligation proximal to the inferior mesenteric artery was associated with a reduced risk (OR = 0.41; 95% CI = 0.19-0.88). Diverting stoma created for <100 days or ≥100 days was also a factor associated with a risk for AL/PA (OR = 3.08, 95% CI = 2-4.75 and OR = 12.95, 95% CI = 9.11-18.50). Interestingly, no significant association between radiological drainage or surgical management of AL/PA and SAS could be highlighted. CONCLUSION: AL/PA was an independent factor associated with the risk for SAS. The treatment of AL/PA was not associated with the occurrence of anastomotic stenosis. Diverting stoma was associated with an increased risk of both AL/PA and SAS, especially if it was left for ≥100 days. Physicians must be aware of this information in order to decide on the best course of action when creating a stoma during elective or emergency surgery.

Impact of the first wave of COVID-19 epidemy on the surgical management of sigmoid diverticular disease in France: National French retrospective study.

OBJECTIVE: To analyze the surgical management of sigmoid diverticular disease (SDD) before, during, and after the first containment rules (CR) for the first wave of COVID-19. METHODS: From the French Surgical Association multicenter series, this study included all patients operated on between January 2018 and September 2021. Three groups were compared: A (before CR period: 01/01/18-03/16/20), B (CR period: 03/17/20-05/03/20), and C (post CR period: 05/04/20-09/30/21). RESULTS: A total of 1965 patients (A n = 1517, B n = 52, C n = 396) were included. The A group had significantly more previous SDD compared to the two other groups (p = 0.007), especially complicated (p = 0.0004). The rate of peritonitis was significantly higher in the B (46.1%) and C (38.4%) groups compared to the A group (31.7%) (p = 0.034 and p = 0.014). As regards surgical treatment, Hartmann's procedure was more often performed in the B group (44.2%, vs A 25.5% and C 26.8%, p = 0.01). Mortality at 90 days was significantly higher in the B group (9.6%, vs A 4% and C 6.3%, p = 0.034). This difference was also significant between the A and B groups (p = 0.048), as well as between the A and C groups (p = 0.05). There was no significant difference between the three groups in terms of postoperative morbidity. CONCLUSION: This study shows that the management of SDD was impacted by COVID-19 at CR, but also after and until September 2021, both on the initial clinical presentation and on postoperative mortality.

StomaCare: quality of life impact after enhanced follow-up of ostomy patients by a home healthcare nursing service-a multicentre, randomized, controlled trial.

AIM: A stoma exposes patients to several complications which could impair their quality of life (QoL). In the last decade, the market for stoma therapy in France has evolved, with a significant increase in the activities of home health providers, meeting a need for patient follow-up and companionship. International studies have demonstrated the impact of the stoma therapist (ST) follow-up on the improvement of an ostomy patient's QoL. However, the impact of home stoma nurse management has not been analysed. In this context we would like to assess the added value on health-related QoL from the enhanced follow-up of ostomy patients by STs. METHODS: This is a randomized, controlled, open, national and multicentre trial (12 centres) which includes patients with an ostomy who benefit from either standard follow-up or from an enhanced and personalized follow-up with, in particular, regular consultations with an ST after discharge. The primary end-point is the 3-month QoL score obtained from the Stoma-QoL questionnaire. The secondary end-points are satisfaction of the care, comparison of QoL scores (Stoma-QoL and EuroQuol EQ-5D) and the economic gains by calculating the consumption of resources between the two arms. There will be a modified intention-to-treat analysis with 6-month follow-up in both study arms. DISCUSSION: The StomaCare trial will be the first randomized controlled study in France to evaluate the impact on QoL of an enhanced follow-up at home of ostomy patients by an ST.

What Is the Optimal Elective Colectomy for Splenic Flexure Cancer: End of the Debate? A Multicenter Study From the GRECCAR Group With a Propensity Score Analysis.

BACKGROUND: The optimal elective colectomy in patients with splenic flexure tumor is debated. OBJECTIVE: This study aimed to compare splenic flexure colectomy, left hemicolectomy, and subtotal colectomy for perioperative, histological, and survival outcomes in this setting. DESIGN: This is a multicenter retrospective cohort study. SETTING: Patients diagnosed with nonmetastatic splenic flexure tumor who underwent elective colectomy were included. PATIENTS: Between 2006 and 2014, 313 consecutive patients were operated on in 15 French Research Group of Rectal Cancer Surgery centers. INTERVENTIONS: Propensity score weighting was performed to compare short- and long-term outcomes. MAIN OUTCOME MEASURES: The primary end point was disease-free survival. Secondary end points included overall survival, quality of surgical resection, overall postoperative morbidity, surgical postoperative morbidity, and rate of anastomotic leakage. RESULTS: The most performed surgery was splenic flexure colectomy (59%), followed by subtotal colectomy (23%) and left hemicolectomy (18%). Subtotal colectomy was more often performed by laparotomy compared with splenic flexure colectomy and left hemicolectomy (93% vs 61% vs 56%, p < 0.0001), and was associated with a longer operative time (260 minutes (120-460) vs 180 minutes (68-440) vs 217 minutes (149-480), p < 0.0001). Postoperative morbidity was similar between the 3 groups, but the median length of hospital stay was significantly longer after subtotal colectomy (13 days (5-56) vs 10 (4-175) vs 9 (4-55), p = 0.0007). The median number of harvested lymph nodes was significantly higher after subtotal colectomy compared with splenic flexure colectomy and left hemicolectomy (24 (8-90) vs 15 (1-81) vs 16 (3-52), p < 0.0001). The rate of stage III disease and the number of patients treated by adjuvant chemotherapy were similar between the 3 groups. There was no difference in terms of disease-free survival and overall survival between the 3 procedures. LIMITATIONS: The study was limited by its retrospective design. CONCLUSIONS: In the elective setting, splenic flexure colectomy is safe and oncologically adequate for patients with nonmetastatic splenic flexure tumor. However, given the oncological clearance after splenic flexure colectomy, it seems that the debate is not completely closed. See Video Abstract at http://links.lww.com/DCR/B703. CUL ES LA COLECTOMA ELECTIVA PTIMA PARA EL CNCER DE NGULO ESPLNICO FIN DEL DEBATE UN ESTUDIO MULTICNTRICO DEL GRUPO GRECCAR CON UN ANLISIS DE PUNTAJE DE PROPENSIN: ANTECEDENTES:La colectomía electiva óptima en pacientes con tumores del ángulo esplénico continua en debate.OBJETIVO:Comparar la colectomía de ángulo esplénico, hemicolectomía izquierda y colectomía subtotal para los resultados perioperatorios, histológicos y de supervivencia en este escenario.DISEÑO:Estudio de cohorte retrospectivo multicéntrico.ESCENARIO:Se incluyeron pacientes diagnosticados de tumores del ángulo esplénico no metastásicos que se sometieron a colectomía electiva.PACIENTES:Entre 2006 y 2014, 313 pacientes consecutivos fueron intervenidos en 15 centros GRECCAR.INTERVENCIONES:Se realizó una ponderación del puntaje de propensión para comparar los resultados a corto y largo plazo.PRINCIPALES MEDIDAS DE RESULTADO:El criterio de valoración principal fue la supervivencia libre de enfermedad. Los criterios de valoración secundarios incluyeron la supervivencia general, la calidad de la resección quirúrgica, la morbilidad posoperatoria general, la morbilidad posoperatoria quirúrgica y la tasa de fuga anastomótica.RESULTADOS:La cirugía más realizada fue la colectomía del ángulo esplénico (59%), seguida de la colectomía subtotal (23%) y la hemicolectomía izquierda (18%). La colectomía subtotal se realizó con mayor frecuencia mediante laparotomía en comparación con la colectomía de ángulo esplénico y la hemicolectomía izquierda (93% frente a 61% frente a 56%, p <0.0001), y se asoció con un tiempo quirúrgico más prolongado (260 min [120-460] frente a 180 min [68-440] frente a 217 min [149-480], p <0.0001). La morbilidad posoperatoria fue similar entre los tres grupos, pero la duración media de la estancia hospitalaria fue significativamente más prolongada después de la colectomía subtotal (13 días [5-56] frente a 10 [4-175] frente a 9 [4-55], p = 0.0007). La mediana del número de ganglios linfáticos extraídos fue significativamente mayor después de la colectomía subtotal en comparación con la colectomía del ángulo esplénico y la hemicolectomía izquierda (24 [8-90] frente a 15 [1-81] frente a 16 [3-52], p <0.0001). La tasa de enfermedad en estadio III y el número de pacientes tratados con quimioterapia adyuvante fueron similares entre los 3 grupos. No hubo diferencias en términos de supervivencia libre de enfermedad y supervivencia general entre los 3 procedimientos.LIMITACIONES:El estudio estuvo limitado por su diseño retrospectivo.CONCLUSIONES:En un escenario electivo, la colectomía del ángulo esplénico es segura y oncológicamente adecuada para pacientes con tumores del ángulo esplénico no metastásicos. Sin embargo, dado el aclaramiento oncológico tras la colectomía del ángulo esplénico, parece que el debate no está completamente cerrado. Consulte Video Resumen en http://links.lww.com/DCR/B703.

Acute urinary retention and urinary tract infection after short-course urinary drainage in colon or high rectum anastomoses: Post hoc analysis of a multicentre prospective database from the GRACE group.

AIM: The aim was to define the risk factors for acute urinary retention (AUR) and urinary tract infections (UTIs) in colon or high rectum anastomosis patients based on the absence of a urinary catheter (UC) or the early removal of the UC (<24 h). METHOD: This is a multicentre, international retrospective analysis of a prospective database including all patients undergoing colon or high rectum anastomoses. Patients were part of the enhanced recovery programme audit, developed by the Francophone Group for Enhanced Recovery after Surgery, and were included if no UC was inserted or if a UC was inserted for <24 h. RESULTS: In all, 9389 patients had colon or high rectum anastomoses using laparoscopy, open surgery or robotic surgery. Among these patients, 4048 were excluded because the UC was left in place >24 h (43.1%) and 97 were excluded because the management of UC was unknown (1%). Among the 5244 colon or high rectum anastomoses patients included, AUR occurred in 5.2% and UTI occurred in 0.7%. UCs were in place for <24 h in 2765 patients (52.7%) and 2479 did not have UCs in place (47.3%). Multivariate analysis showed that management of the UC was not significantly associated with the occurrence of AUR and that risk factors for AUR were male gender, ≥65 years old, having an American Society of Anesthesiologists score ≥3 and receiving epidural analgesia. Conversely, being of male gender was a protective factor of UTI, while being ≥65 years old, having open surgery and receiving epidural analgesia were risk factors for UTIs. The management of the UC was not significantly associated with the occurrence of UTIs but the occurrence of AUR was a more significant risk factor for UTIs. CONCLUSION: UCs in place for <24 h did not reduce the occurrence of AUR or UTI compared to the absence of UCs.

A multicentre, prospective cohort study of handsewn versus stapled intracorporeal anastomosis for robotic hemicolectomy.

AIM: Robotic right hemicolectomy is gaining in popularity due to the recognized technical benefits associated with the robotic platform. However, there is a lack of standardization regarding the optimal anastomotic technique in this cohort of patients, namely stapled or handsewn intra- or extra-corporeal anastomosis. The ergonomic benefit associated with the robotic platform lends itself to intracorporeal anastomosis (ICA). The aim of this study was to compare the short-term clinical outcomes of stapled versus handsewn ICA. METHOD: A multicentre prospective cohort study was undertaken across four high-volume robotic centres in France between September 2018 and December 2020. All adult patients undergoing an elective robotic right hemicolectomy with an ICA performed and a minimum postoperative follow-up of 30 days were included. The primary endpoint of our study was anastomotic leak within 30 days postoperatively. RESULTS: A total of 144 patients underwent robotic right hemicolectomy: 92 (63.8%) had a stapled ICA and 52 (36.1%) a handsewn ICA. The operative indication was adenocarcinoma in 90% with a stapled ICA compared with 62% in the handsewn ICA group (p < 0.001). The overall operating time was longer in the handsewn ICA group compared with the stapled ICA group (219 min vs. 193 min; p = 0.001). The anastomotic leak rate was 3.3% in stapled ICA and 3.8% in handsewn ICA (p = 1.00). There was no difference in the rate or severity of postoperative morbidity. CONCLUSION: ICA robotic hemicolectomy is technically safe and is associated with low rates of anastomotic leak overall and equivalent clinical outcomes between the two techniques.

Ano-rectovaginal fistula after obstetrical anal sphincter injury: Diverting stoma does not improve the surgical results.

AIM: Ano-rectovaginal fistulas (ARVF) are challenging for the surgeon. Most of the series mix aetiologies, leading to confusion with respect to the conclusion. The aim of this study was to assess the factors associated with the success of ARVF management following obstetrical anal sphincter injury (OASIS). METHODS: This retrospective multicentric study included all the patients undergoing surgery for ARVF identified by the hospital codes. Patients for whom the aetiology of ARVF was not OASIS were excluded. The major outcome measure was the success of the procedure. RESULTS: Sixty patients with treated ARVF due to OASIS were identified. The success of overall management was 91.7%. Female patients underwent a mean of 2.5 (±1.7) procedures. A diverting stoma was formed in 29 patients (48.3%) of which 26 were closed at the end of the management period (89.7%). Of the 148 surgical procedures, only 55 were successful (37.2%). The order of the procedures (OR = 1.38; 95% CI: 0.75-2.51) or the diverting stoma (OR = 1.46; 95% CI: 0.31-6.91) were not significantly associated with the success of the surgery. However, Martius flap (OR = 4.13; 95% CI: 1.1-15.54) and Musset procedures (OR = 5.79; 95% CI: 1.77-18.87) produced better results than the endorectal advancement flap (ERAF). The other procedures did not show a significant correlation with management success. CONCLUSION: A diverting stoma is not mandatory in the management of ARVF due to OASIS to improve the success of the surgical procedure. While the Martius flap procedure offers better results, the ERAF procedure may be preferred as a primary intervention in the absence of sphincter injury as it is less invasive. In cases of residual sphincter injury, the Musset procedure is most likely to be the best option.

Is it safe to perform an anastomosis for rectal cancer after prostate cancer? A multicentre study of 126 patients from the GRECCAR group.

AIM: To determine the safety of performing an anastomosis after rectal cancer (RC) resection in patients with a previously treated prostate cancer (PC). METHODS: Patients with a previously treated PC who underwent rectal resection from 2008 to 2018 were retrospectively included. Outcomes were compared between patients who underwent rectal resection with anastomosis (restorative surgery, RS+ group) and those with a definitive stoma (RS- group). In the RS+ group, anastomotic leak (AL) rates were assessed according to the type of reconstruction. RESULTS: A total of 126 patients underwent rectal surgery for mid-low RC after a previous PC treated by radiotherapy (RT) and/or radical prostatectomy. Overall, 80 patients (63%) underwent a RS and 46 patients (37%) underwent rectal surgery with a definitive stoma. There was no statistical difference between the two groups in terms of intraoperative data, except for the type of resection with more multivisceral resection in the RS- group (p < 0.01). In the RS+group, a diverting stoma was performed in 74% of cases. No difference between the two groups in terms of overall morbidity was found. In the RS+group (n = 80), 17 patients (21%) experienced AL. Of these, none was observed when delayed coloanal anastomosis was performed (p = 0.16). Long-term permanent stoma in the RS+ group was 16% (n = 13). CONCLUSION: Restorative surgery after resection for RC in patients with a previous history of RT and/or radical prostatectomy for PC is safe without additional morbidity. In selected patients for restorative surgery, performing delayed coloanal anastomosis may represent a promising option.

Surgical Management of Retrorectal Tumors: A French Multicentric Experience of 270 Consecutives Cases.

OBJECTIVE: To report the largest multicentric experience on surgical management of retrorectal tumors (RRT). BACKGROUND: Literature data on RRT is limited. There is no consensus concerning the best surgical approach for the management of RRT. METHODS: Patients operated for RRT in 18 academic French centers were retrospectively included (2000-2019). RESULTS: A total of 270 patients were included. Surgery was performed through abdominal (n = 72, 27%), bottom (n = 190, 70%), or combined approach (n = 8, 3%). Abdominal approach was laparoscopic in 53/72 (74%) and bottom approach was Kraske modified procedures in 169/190 (89%) patients. In laparoscopic abdominal group, tumors were more frequently symptomatic (37/53, 70% vs 88/169, 52%, P = 0.02), larger [mean diameter = 60.5 ± 24 (range, 13-107) vs 51 ± 26 (20-105) mm, P = 0.02] and located above S3 vertebra (n = 3/42, 7% vs 0%, P = 0.001) than those from Kraske modified group. Laparoscopy was associated with a higher risk of postoperative ileus (n = 4/53, 7.5% vs 0%, P = 0.002) and rectal fistula (n = 3/53, 6% vs 0%, P=0.01) but less wound abscess (n = 1/53, 2% vs 24/169, 14%, P = 0.02) than Kraske modified procedures. RRT was malignant in 8%. After a mean follow up of 27 ±39 (1-221) months, local recurrence was noted in 8% of the patients. After surgery, chronic pain was observed in 17% of the patients without significant difference between the 2 groups (15/74, 20% vs 3/30, 10%; P = 0.3). CONCLUSIONS: Both laparoscopic and Kraske modified approaches can be used for surgical treatment of RRT (according to their location and their size), with similar long-term results.

End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial.

OBJECTIVE: To evaluate whether systematic mesh implantation upon primary colostomy creation was effective to prevent PSH. SUMMARY OF BACKGROUND DATA: Previous randomized trials on prevention of PSH by mesh placement have shown contradictory results. METHODS: This was a prospective, randomized controlled trial in 18 hospitals in France on patients aged ≥18 receiving a first colostomy for an indication other than infection. Participants were randomized by blocks of random size, stratified by center in a 1:1 ratio to colostomy with or without a synthetic, lightweight monofilament mesh. Patients and outcome assessors were blinded to patient group. The primary endpoint was clinically diagnosed PSH rate at 24 months of the intention-to-treat population. This trial was registered at ClinicalTrials.gov, number NCT01380860. RESULTS: From November 2012 to October 2016, 200 patients were enrolled. Finally, 65 patients remained in the no mesh group (Group A) and 70 in the mesh group (Group B) at 24 months with the most common reason for drop-out being death (n = 41). At 24 months, PSH was clinically detected in 28 patients (28%) in Group A and 30 (31%) in Group B [P = 0.77, odds ratio = 1.15 95% confidence interval = (0.62;2.13)]. Stoma-related complications were reported in 32 Group A patients and 37 Group B patients, but no mesh infections. There were no deaths related to mesh insertion. CONCLUSION: We failed to show efficiency of a prophylactic mesh on PSH rate. Placement of a mesh in a retro-muscular position with a central incision to allow colon passage cannot be recommended to prevent PSH. Optimization of mesh location and reinforcement material should be performed.

Rectal endometriosis: predictive MRI signs for segmental bowel resection.

OBJECTIVE: To retrospectively determine the accuracy of MRI rectal and pararectal signs in predicting the necessity for segmental resection in the case of lesions located in the rectum. METHODS: MR images of consecutive patients treated for rectal endometriosis over a 5-year period were reviewed in consensus by two blinded readers. A systematic analysis of 7 rectal (lesion length, transverse axis, thickness and circumference, and presence of a convex base, submucosal oedema and hyperintense cystic areas) and 4 pararectal (posterior vaginal fornix, parametrial, ureteral and sacro-recto-genital septum involvements) signs was performed for each lesion. MRI results were compared to the surgical procedure performed (shaving versus segmental resection). RESULTS: Among 61 patients studied, 32 received a segmental resection and 29, a shaving. Receiver operating characteristic curve analysis allowed determining cut-off values for length (≥ 32 mm), transverse axis (≥ 22 mm), thickness (≥ 14 mm) and circumference (≥ 3/8 radii). The 7 rectal signs, and only the sacro-recto-genital septum pararectal sign, were significantly associated with segmental resection in univariate analysis, nodular thickness ≥ 14 mm and circumference ≥ 3/8 radii being the most predictive signs (odds ratio 94.5 and 60.4, respectively). These 2 signs remained positively associated with segmental resection in multivariate analysis and, when combined, were predictive of segmental resection with an accuracy of 90.2%. CONCLUSION: Assessing MRI rectal and pararectal signs may accurately predict the need for segmental resection versus a more conservative approach such as shaving for rectal lesion management. KEY POINTS: • MRI analysis of rectal endometriosis, taking into account rectal and pararectal signs, may assist surgeons in the decision-making process, in counselling patients regarding the surgical procedure and in adequately allocating resources. • Among rectal signs, nodular thickness ≥ 14 mm and a circumference ≥ 38% were the most predictive signs of segmental resection. • Among pararectal signs, only the sacro-recto-genital septum involvement was significantly associated with segmental resection.

Implications of Pathologic Findings in Cytoreductive Surgery Specimens on Treatment of Colorectal Peritoneal Metastases: Results of a Prospective Multicentric Study.

BACKGROUND: A surgical peritoneal cancer index of >20 is often used to exclude patients from cytoreductive surgery for colorectal peritoneal metastases. The pathologic peritoneal cancer index in these patients may be <20. OBJECTIVE: The purpose of this study was to compare the pathologic and surgical findings and to look at potential pathologic prognostic factors. DESIGN: This is a prospective observational study including patients undergoing cytoreductive surgery. SETTINGS: The study was carried out at 3 peritoneal surface malignancy centers, 1 in France and 2 in India. PATIENTS: One-hundred patients were included from July 1, 2018, to June 30, 2019. MAIN OUTCOME MEASURES: The pathologic peritoneal cancer index, peritoneal disease distribution, pathologic response to chemotherapy, factors affecting them and their relation with surgical findings, and potential prognostic value were explored. RESULTS: Ninety percent had colonic primaries. Fifty-one percent had left-sided tumors. The median surgical peritoneal cancer index was 4 (range, 0-35). Upper regions were involved in 32% and small bowel regions in 26%, and their involvement increased with a higher peritoneal cancer index (p < 0.001). The median pathologic peritoneal cancer index was 2 (range, 0-27) and was less than the surgical peritoneal cancer index in 57%. A pathologic complete response was obtained in 25%. Patients with pathologic complete response received more antiepidermal growth factor receptor therapy (p = 0.008); more leucovorin, 5-fluorouracil, and oxaliplatin; and folinic acid, fluorouracilirin, irinotecan hydrochloride, and oxaliplatin (p < 0.001). In 7 patients with a surgical peritoneal cancer index of >20, pathologic peritoneal cancer index was <20 in 4 patients. Disease in the primary tumor/anastomotic site was found in ≈80%. LIMITATIONS: Survival outcomes are not available. CONCLUSIONS: Surgical peritoneal cancer index of >20 should not be the sole factor to exclude patients from surgery, especially in responders to systemic therapies. The pathologic peritoneal cancer index, pathologic response to systemic chemotherapy, and disease distribution in the peritoneal cavity should be meticulously documented. Correlation with survival will define their future prognostic value. The primary anastomotic site is a common site for peritoneal disease and should be carefully evaluated in all patients. See Video Abstract at http://links.lww.com/DCR/B490. IMPLICACIONES DE LOS HALLAZGOS PATOLÓGICOS EN MUESTRAS DE CIRUGÍA CITORREDUCTORA EN EL TRATAMIENTO DE METÁSTASIS PERITONEALES COLORRECTALES: RESULTADOS DE UN ESTUDIO PROSPECTIVO MULTICÉNTRICO: Una ICP quirúrgica de >20 se utiliza a menudo para excluir a los pacientes de la cirugía citorreductora por metástasis peritoneales colorrectales. La PCI patológica en estos pacientes puede ser <20.Comparar los hallazgos patológicos y quirúrgicos y observar los posibles factores pronósticos patológicos.Se trata de un estudio observacional prospectivo que incluye a pacientes sometidos a cirugía citorreductora.El estudio se llevó a cabo en tres centros de malignidad de la superficie peritoneal, 1 en Francia y 2 en India.Se incluyeron 100 pacientes desde el 1 de julio de 2018 al 30 de junio de 2019.No hubo intervención terapéutica.Se exploró la ICP patológica, la distribución de la enfermedad peritoneal, la respuesta patológica a la quimioterapia, los factores que la afectan y su relación con los hallazgos quirúrgicos y el valor pronóstico potencial.El noventa por ciento tenía lesiones primarias colónicas. El 51% tenía tumores del lado izquierdo. La mediana de la ICP quirúrgica 4 [0-35]. Las regiones superiores estuvieron involucradas en el 32% y las regiones del intestino delgado en un 26% y su participación aumentó con una ICP más alta (p <0,001). La mediana de la ICP patológica fue 2 [0-27] y fue menor que la ICP quirúrgica en el 57%. Se obtuvo respuesta patológica completa en el 25%. Los pacientes con respuesta patológica completa recibieron más terapia anti-EGFR (p = 0,008) y más FOLFOX y FOLFIRINOX (p <0,001). En 7 pacientes con una ICP quirúrgica de> 20, la ICP patológica fue menor de 20 en 4 pacientes. Se encontró enfermedad en el tumor primario/anastomósis en casi el 80%.Los resultados de supervivencia no están disponibles.La ICP quirúrgica de> 20 no debería ser el único factor para excluir a los pacientes de la cirugía, especialmente en los que responden a las terapias sistémicas. La PCI patológica, la respuesta patológica a la quimioterapia sistémica y la distribución de la enfermedad en la cavidad peritoneal deben documentarse meticulosamente. La correlación con la supervivencia definirá su valor pronóstico futuro. El sitio anastomótico primario es un sitio común de enfermedad peritoneal y debe evaluarse cuidadosamente en todos los pacientes. Consulte Video Resumen en http://links.lww.com/DCR/Bxxx. (Traducción-Dr. Gonzalo Hagerman).

Are colorectal cancer patients at risk for COVID-19 infection during the postoperative period? The Covid-GRECCAR study.

INTRODUCTION: During the COVID-19 pandemic, cancer patients have been regarded as having a high risk of severe events if they are infected with SARS-CoV-2, particularly those under medical or surgical treatment. The aim of this study was to assess the posttreatment risk of infection by SARS-CoV-2 in a population of patients operated on for colorectal cancer 3 months before the COVID-19 outbreak and who after hospitalization returned to an environment where the virus was circulating. MATERIALS AND METHODS: This French, multicenter cohort study included consecutive patients undergoing elective surgery for colorectal cancer between January 1 and March 31, 2020, at 19 GRECCAR hospitals. The outcome was the rate of COVID-19 infection in this group of patients who were followed until June 15, 2020. RESULTS: This study included 448 patients, 262 male (58.5%) and 186 female (41.5%), who underwent surgery for colon cancer (n = 290, 64.7%), rectal cancer (n = 155, 34.6%), or anal cancer (n = 3, 0.7%). The median age was 68 years (19-95). Comorbidities were present in nearly half of the patients, 52% were at least overweight, and the median BMI was 25 (12-42). At the end of the study, 448 were alive. Six patients (1.3%) developed COVID-19 infection; among them, 3 were hospitalized in the conventional ward, and none of them died. CONCLUSION: The results are reassuring, with only a 1.3% infection rate and no deaths related to COVID-19. We believe that we can operate on colorectal cancer patients without additional mortality from COVID-19, applying all measures aimed at reducing the risk of infection.

Impact of preoperative enteral nutritional support on postoperative outcome in patients with Crohn's disease complicated by malnutrition: Results of a subgroup analysis of the nationwide cohort registry from the GETAID Chirurgie group.

AIM: Postoperative morbidity is high in patients operated on for Crohn's disease (CD) complicated by malnutrition. This study aimed to evaluate the impact of preoperative enteral nutritional support (PENS) on postoperative outcome in patients with CD complicated by malnutrition included in a prospective nationwide cohort. METHOD: Malnutrition was defined as body mass index <18 kg/m2 and/or albuminaemia <30 g/L and/or weight loss >10%. Failure of PENS was defined as the requirement for additional preoperative parenteral nutrition to PENS. Univariate analysis of the risk factors for PENS failure was performed. Propensity score matching (PSM) was used to compare the outcomes between 'upfront surgery' and 'PENS' groups. The primary endpoint was the rate of intra-abdominal septic morbidity and/or temporary defunctioning stoma. RESULTS: Among 592 patients included, 149 were selected. In the intention-to-treat population including 20 (13.4%) patients with PENS failure after PSM, 78 'upfront surgery' and 71 'PENS'-matched patients were compared, with no significant difference in the primary endpoint. Perforating CD and preoperative intra-abdominal fistula were associated with PENS failure [37.5 vs 16.1% (P = 0.047) and 41.2% vs 16.2% (P = 0.020), respectively]. After exclusion of these 20 patients, PSM was used to compare 45 'upfront surgery' and 51 'PENS'-matched patients, with a significantly decreased rate of intra-abdominal septic complications and/or temporary defunctioning stoma in the PENS group (19.6 vs 42.2%, P = 0.016). CONCLUSION: Preoperative enteral nutritional support is associated with a trend but no conclusive evidence of a reduction in intra-abdominal septic complications and/or requirement for defunctioning stoma. Patients with perforating CD complicated with malnutrition are at risk of PENS failure.

Low Levels of Fecal Calprotectin 3 Months After Surgery Predict Subsequent Endoscopic Postoperative Remission in Crohn's Disease.

BACKGROUND/AIMS: In Crohn's disease (CD) few data are available on the usefulness of monitoring fecal calprotectin (FC) in the early postoperative setting. We assessed prospectively the accuracy of FC measured 3 months after surgery to predict the risk of endoscopic postoperative recurrence (POR) within 1 year after resection. METHODS: In 55 consecutive CD patients who had undergone ileocolonic resection samples were collected 3 months after surgery for measuring serum CRP and FC. Endoscopic POR was assessed by ileocolonoscopy within 6-12 months (median 7 months). Receiver operating characteristic (ROC) curves were generated to assess accuracy of the markers, to determine the best threshold and to calculate sensitivity, specificity, positive and negative predictive values. RESULTS: In contrast with median CRP levels, median FC concentrations measured 3 months after surgery were significantly higher in patients who later experienced endoscopic POR (Rutgeerts ≥ i2) compared with those who stayed in endoscopic remission within the following 6-12 months (205 µg/g IQR [106-721] vs. 103 µg/g IQR [60-219], p = 0.008). Area under the ROC curve for FC was 0.71. The best cutoff value of FC to identify patients in subsequent endoscopic remission 3 months after surgery was 65 µg/g (96% sensitivity, 31% specificity, 50% positive and 91% negative predictive values). In multivariate analysis, FC < 65 µg/g at 3 months was the only factor associated with subsequent endoscopic remission. CONCLUSION: FC measured 3 months after surgery below 65 µg/g is an accurate marker to identify CD patients who will later stay in endoscopic remission within 1 year after resection.

Milk polar lipids reduce lipid cardiovascular risk factors in overweight postmenopausal women: towards a gut sphingomyelin-cholesterol interplay.

OBJECTIVE: To investigate whether milk polar lipids (PL) impact human intestinal lipid absorption, metabolism, microbiota and associated markers of cardiometabolic health. DESIGN: A double-blind, randomised controlled 4-week study involving 58 postmenopausal women was used to assess the chronic effects of milk PL consumption (0, 3 or 5 g-PL/day) on lipid metabolism and gut microbiota. The acute effects of milk PL on intestinal absorption and metabolism of cholesterol were assessed in a randomised controlled crossover study using tracers in ileostomy patients. RESULTS: Over 4 weeks, milk PL significantly reduced fasting and postprandial plasma concentrations of cholesterol and surrogate lipid markers of cardiovascular disease risk, including total/high-density lipoprotein-cholesterol and apolipoprotein (Apo)B/ApoA1 ratios. The highest PL dose preferentially induced a decreased number of intestine-derived chylomicron particles. Also, milk PL increased faecal loss of coprostanol, a gut-derived metabolite of cholesterol, but major bacterial populations and faecal short-chain fatty acids were not affected by milk PL, regardless of the dose. Acute ingestion of milk PL by ileostomy patients shows that milk PL decreased cholesterol absorption and increased cholesterol-ileal efflux, which can be explained by the observed co-excretion with milk sphingomyelin in the gut. CONCLUSION: The present data demonstrate for the first time in humans that milk PL can improve the cardiometabolic health by decreasing several lipid cardiovascular markers, notably through a reduced intestinal cholesterol absorption involving specific interactions in the gut, without disturbing the major bacterial phyla of gut microbiota. TRIAL REGISTRATION NUMBER: NCT02099032 and NCT02146339; Results.

Hospital Length of Stay Reduction Over Time and Patient Readmission for Severe Adverse Events Following Surgery.

OBJECTIVE: The aim of the study was to investigate whether patients who undergo surgery in hospitals experiencing significant length of stay (LOS) reductions over time are exposed to a higher risk of severe adverse events in the postoperative period. SUMMARY BACKGROUND DATA: Surgical care innovation has encouraged hospitals to shorten LOS under financial pressures with uncertain impact on patient outcomes. METHODS: We selected all patients who underwent elective colectomy or urgent hip fracture repair in French hospitals between 2013 and 2016. For each procedure, hospitals were categorized into 3 groups according to variations in their median LOS as follows: major decrease, moderate decrease, and no decrease. These groups were matched using propensity scores based on patients' and hospitals' potential confounders. Potentially avoidable readmission for severe adverse events and death at 6 months were compared between groups using Cox regressions. RESULTS: We considered 98,713 patients in 540 hospitals for colectomy and 206,812 patients in 414 hospitals for hip fracture repair before matching. After colectomy, patient outcomes were not negatively impacted when hospitals reduced their LOS [hazard ratio (95% confidence interval): 0.93 (0.78-1.10)]. After hip fracture repair, patients in hospitals with major decreases in LOS had a higher risk of severe adverse events [1.22 (1.11-1.34)] and death [1.17 (1.04-1.32)]. CONCLUSIONS: Patients who underwent surgical procedures in hospitals experiencing major decreases in LOS were demonstrated worse postoperative outcomes after urgent hip fracture repair and not after elective colectomy. Development of care bundles to enhance recovery after emergency surgeries may allow better control of LOS reduction and patient outcomes.

Surgical Management and Outcomes of Rectal Cancer with Synchronous Prostate Cancer: A Multicenter Experience from the GRECCAR Group.

BACKGROUND: Synchronous prostate cancer (PC) and rectal cancer (RC) is a rare clinical situation. While combining curative-intent management for both cancers can be challenging, available data for guiding the multidisciplinary strategy are lacking. METHODS: Consecutive patients undergoing rectal resection for a mid-low RC with synchronous PC treated at 9 tertiary-care centers between 2008 and 2018 were included. Management strategy and data on postoperative and long-term outcomes were retrospectively analyzed. RESULTS: Overall, 25 patients underwent curative-intent RC resection combined with PC management. Nine (36%), 10 (40%) and 6 (24%) patients had low-, intermediate-, and high-risk PC, respectively. Management mostly consisted of chemoradiotherapy combined in 18 patients (72%) with either TME in 12 patients or pelvic exenteration for resection of both cancers in 6 patients. Most patients underwent RC resection using a laparoscopic approach (n = 16, 64%). Anastomosis was performed in 18 patients (72%) of whom 13 received diverting ileostomy. The complete R0 resection rate was 96% (n = 24). The overall morbidity rate was 64% (n = 16) and 5 patients (20%) experienced severe surgical morbidity of which two died within 90 days of surgery after pelvic exenteration. Among patients with anastomosis, 2 patients (11%) experienced anastomotic leak requiring surgical management. After a median follow-up of 31.2 months, 3-year OS and RFS were 80.2% (CI 95% 58.8-92.2) and 68.6% (CI 95% 42.3-84.8), respectively. CONCLUSIONS: This series is the largest to report that simultaneous curative-intent management of synchronous PC and RC is feasible and safe. Pelvic exenteration might be a better option when RC complete resection seems not achievable through TME.

Risk of Omental Metastases in Patients Undergoing Cytoreductive Surgery for Colorectal Peritoneal Metastases.

BACKGROUND: Complete cytoreductive surgery of macroscopic tumor is a potentially curative treatment for patients with colorectal peritoneal metastases. OBJECTIVE: This study aims to determine the risk of microscopic tumor involvement of the greater omentum in patients with normal-looking omentum at the time of cytoreductive surgery for colorectal peritoneal metastases. DESIGN: This was a cohort study. SETTINGS: The prospective BIG-RENAPE database (NCT02823860) was analyzed. PATIENTS: All patients who underwent a complete cytoreductive surgery with greater omentectomy for colorectal peritoneal metastases at a single institution between January 2005 and December 2017 were included. MAIN OUTCOME MEASURE: Data regarding involvement of the greater omentum were extracted from surgical and pathological records. RESULTS: Of 337 patients who underwent cytoreductive surgery for colorectal peritoneal metastases, 241 (71.51%) presented macroscopic omental invasion. Among the 96 patients who underwent a complete cytoreductive surgery with no macroscopic evidence of disease in the greater omentum during surgical exploration, 17 patients (17.70%) had microscopic evidence of tumor in the omentum. Patients with pathological evidence of omental tumor involvement were more likely to have a higher peritoneal cancer index (median 9 vs 4, p = 0.006). LIMITATIONS: No survival analysis could be provided regarding the impact of omentectomy. CONCLUSION: In patients with a normal-looking omentum during surgery for colorectal peritoneal metastases, microscopic tumor was present in 17%. Routine greater omentectomy should be considered in these patients to ensure complete cytoreduction. See Video Abstract at http://links.lww.com/DCR/B262.ClinicalTrials.gov Identifier: NCT02823860 RIESGO DE METÁSTASIS OMENTALES EN PACIENTES SOMETIDOS A CIRUGÍA CITORREDUCTORA, POR METÁSTASIS PERITONEALES COLORRECTALES: La cirugía citorreductora completa del tumor macroscópico, es un tratamiento potencialmente curativo, en pacientes con metástasis peritoneales colorrectales.Determinar el riesgo de afectación tumoral microscópica del epiplón mayor, en pacientes con epiplón de aspecto normal, al momento de la cirugía citorreductora por metástasis peritoneales colorrectales.Este fue un estudio de cohorte.Se analizó la base de datos prospectiva BIG-RENAPE (NCT02823860).Se incluyeron a todos los pacientes sometidos a una cirugía citorreductora completa con omentectomía mayor, por metástasis peritoneales colorrectales, de una sola institución, entre enero de 2005 y diciembre de 2017.Se extrajeron los datos de la afectación del epiplón mayor, de los registros quirúrgicos y patológicos.De 337 pacientes sometidos a cirugía citorreductora por metástasis peritoneales colorrectales, 241 (71.51%) presentaron invasión omental macroscópica. Entre los 96 pacientes sometidos a cirugía citorreductora completa, sin evidencia macroscópica de enfermedad en el epiplón mayor, durante la exploración quirúrgica, 17 pacientes (17,70%) tuvieron en el epiplón, evidencia microscópica de tumor. Los pacientes con evidencia patológica de afectación del tumor omental, fueron más propensos a tener un índice de cáncer peritoneal más alto (mediana 9 frente a 4, p = 0,006).No se pudo obtener ningún análisis de supervivencia, sobre el impacto de la omentectomía.En pacientes con epiplón de aspecto normal, durante la cirugía por metástasis peritoneales colorrectales, estuvo presente el tumor microscópico, en el 17% de los casos. Se debe considerar una omentectomía mayor de rutina en estos pacientes, para asegurar una citorreducción completa. Consulte Video Resumen http://links.lww.com/DCR/B262.Identificador de ClinicalTrials.gov: NCT02823860.