Use of Darvadstrocel (Allogenic Stem Cell Therapy) for Crohn's Fistulas in Real Clinical Practice: The National Project to Implement Mesenchymal Stem Cell for the Treatment of Perianal Crohn's Fistula (the PRIME Study).

BACKGROUND: Perianal fistulas may affect 15% to 50% of patients with Crohn's disease. Treatment is complex, requiring a multidisciplinary approach. Darvadstrocel (allogenic mesenchymal cells obtained from lipoaspirates) was approved in 2018 by the European and Spanish Agencies of Medicines and Medical Products as a treatment for fistulas in Crohn's disease. Recent guidelines from the European Crohn's and Colitis Organisation and Spanish Working Group on Crohn's Disease and Ulcerative Colitis state that darvadstrocel is effective with a favorable safety profile and a strong level of evidence (n = 2). OBJECTIVE: Presenting real-world effectiveness data for darvadstrocel in a Spanish population. DESIGN: Observational retrospective cohort study with prospective data gathering. SETTINGS: The study was conducted at 14 institutions in Spain. PATIENTS: From November 2019 to April 2022, all patients (n = 73) treated with darvadstrocel in these institutions were included, fulfilling the following criteria: 1) complex fistula/s in a patient with Crohn's disease; 2) failure of conventional and antitumor necrosis factor treatment; and 3) the absence of collections of >2 cm confirmed by pelvic MRI at the time of surgery. INTERVENTIONS: Darvadstrocel treatment. MAIN OUTCOME MEASURES: Clinical response (closure of 50% or more of external openings), complete clinical closure (100% of external openings), and radiological closure (no fluid collection >2 cm, edema, or inflammation) evaluated 6 months after treatment. RESULTS: Clinical response was observed in 63 patients (86.3%), complete clinical closure in 50 patients (68.5%), and radiological closure in 45 patients (69.2%). Combined clinical and radiological response was observed in 41 patients (63.1%). Not all clinically healed patients had radiological closure, and vice versa. No serious adverse events were reported. LIMITATIONS: Retrospective nature of the study. CONCLUSIONS: Study results were consistent with those reported in previous clinical trials, real-world efficacy findings from the INSPIRE study (assessing darvadstrocel effectiveness in Europe, Israel, Switzerland, United Kingdom, and Japan), and previously published literature. Darvadstrocel was effective and demonstrated a favorable safety profile when used in normal clinical practice for the treatment of fistulas in Crohn's disease. See Video Abstract . USO DE DARVADSTROCEL TERAPIA CON CLULAS MADRE ALOGNICAS PARA FSTULA EN ENFERMEDAD DE CROHN EN LA PRCTICA CLNICA REAL EL PROYECTO NACIONAL PARA IMPLEMENTAR DE CLULAS MADRE MESENQUIMALES PARA EL TRATAMIENTO DE LA FSTULA DE CROHN PERIANAL EL ESTUDIO PRIME: ANTECEDENTES:Las fístulas perianales pueden afectar entre el 15 y el 50% de los pacientes con enfermedad de Crohn. El tratamiento es complejo y requiere un enfoque multidisciplinario. El darvadstrocel (células mesenquimales alogénicas obtenidas a partir de lipoaspirados) fue aprobado en 2018 por las Agencias Europea y Española de Medicamentos y Productos Sanitarios como tratamiento de las fístulas en la EC. Las recientes directrices de la Organización Europea de Crohn y Colitis y del Grupo de Trabajo Español sobre la Enfermedad de Crohn y Colitis Ulcerosa afirman que darvadstrocel es eficaz con un perfil de seguridad favorable y un sólido nivel de evidencia (2).OBJETIVO:Presentar datos de eficacia real de darvadstrocel en población española.DISEÑO:Estudio de cohorte retrospectivo observacional con recopilación prospectiva de datos.ESCENARIO:14 instituciones.PACIENTES:Desde noviembre de 2019 hasta abril de 2022, se incluyeron todos los pacientes (73) tratados con darvadstrocel en estas instituciones, que cumplieron los siguientes criterios: 1) fístula/s compleja/s en un paciente con enfermedad de Crohn; 2) fracaso del tratamiento convencional y anti factor de necrosis tumoral; 3) ausencia de colecciones > 2 cm confirmada por resonancia magnética pélvica en el momento de la cirugía.INTERVENCIONES:Tratamiento con Darvadstrocel.PRINCIPALES MEDIDAS DE RESULTADO:Respuesta clínica (cierre de ≥50% de las aberturas externas), cierre clínico completo (100% de las aberturas externas) y cierre radiológico (sin acumulación de líquido >2 cm, sin edema ni inflamación) evaluados 6 meses después del tratamiento.RESULTADOS:Se observó respuesta clínica en 63 pacientes (86.3%), cierre clínico completo en 50 pacientes (68.5%) y cierre radiológico en 45 pacientes (69.2%). Se observó respuesta clínica y radiológica combinada en 41 pacientes (63.1%). No todos los pacientes clínicamente curados tuvieron cierre radiológico y viceversa. No hubo eventos adversos graves reportados.LIMITACIONES:Estudio retrospectivoCONCLUSIONES:Los resultados del estudio fueron consistentes con los informados en ensayos clínicos anteriores, los hallazgos de eficacia en el mundo real del estudio INSPIRE (que evalúa la efectividad de darvadstrocel en Europa, Israel, Suiza, el Reino Unido y Japón) y la literatura publicada anteriormente. Darvadstrocel fue eficaz y demostró un perfil de seguridad favorable cuando se utiliza en la práctica clínica habitual para el tratamiento de fístulas en la enfermedad de Crohn. (Traducción-Dr. Jorge Silva Velazco ).

Impact on defecatory, urinary and sexual function after high-tie sigmoidectomy: a post-hoc analysis of a multicenter randomized controlled trial comparing extended versus standard complete mesocolon excision.

OBJECTIVE: To assess the effect of high inferior mesenteric artery tie on defecatory, urinary, and sexual function after surgery for sigmoid colon cancer. Performing a sigmoidectomy poses a notable risk of causing injury to the preaortic sympathetic nerves during the high ligation of the inferior mesenteric artery, as well as to the superior hypogastric plexus during dissection at the level of the sacral promontory. Postoperative defecatory and genitourinary dysfunction after sigmoid colon resection are often underestimated and underreported. METHODS: This study is a secondary research of a multicenter, single-blind, randomized clinical trial. The trial involved patients with sigmoid cancer who underwent either extended complete mesocolic excision (e-CME) or standard CME (s-CME). Patients completed questionnaires to assess defecatory, urinary, and sexual function before, 1 month after surgery, and 1 year after surgery. Multivariate analysis was conducted to identify factors associated with functional dysfunction. RESULTS: Seventy-nine patients completed functional assessments before and 1 year after surgery. One year after sigmoidectomy with a high tie of the inferior mesenteric artery, 15.2% of patients had minor low anterior resection syndrome (LARS) and 12.7% had major LARS; 22.2% of males and 29.4% of females had urinary dysfunction; and 43.8% of males and 27.3% of females had sexual dysfunction. After multivariate analysis, no significant associations were found between clinical and surgical factors and gastrointestinal or urinary dysfunction after 1 year of surgery. Age was identified as the only factor linked to sexual dysfunction in both sexes (women, ß = - 0.54, p = 0.002; men ß = - 0.38, p = 0.010). Regarding recovery outcomes, diabetes mellitus was identified as a contributing factor to suboptimal gastrointestinal recovery (p = 0.033) and urinary recovery in women (p = 0.039). Furthermore, the treatment arm was found to be significantly associated with the recovery of erectile function after 1 year of surgery (p = 0.046). CONCLUSIONS: A high tie of the inferior mesenteric artery during sigmoidectomy is associated with a high incidence of defecatory and genitourinary dysfunction. Age was identified as a significant factor associated with sexual dysfunction 1 year after sigmoid colon resection in both sexes. TRIAL REGISTRATION: Clinical trials NCT03083951 HIGHLIGHTS: • One year after high-tie sigmoidectomy, 27.9% of patients had LARS; 22.2% of the men and 29.4% of the women had urinary dysfunction; and 43.8% of the men and 27.3% of the women had sexual dysfunction. • e-CME is associated with a high rate of urinary dysfunction in men 1 year after surgery. However, after multivariate analysis, no association was found between e-CME and urinary dysfunction in men. • Age was correlated with the recovery of sexual function in both sexes 1 year after surgery. Furthermore, diabetes mellitus was identified as the factor associated with poorer recovery of urinary function in females.

An analysis of randomized controlled trials on anal fistula conducted between 2000 and 2020 based on the Fragility Index and Reverse Fragility Index.

AIM: The aim of this work was to evaluate the robustness of randomized controlled trials (RCTs) on anal fistula management using the news tools of Fragility Index (FI), Reverse Fragility Index (RFI) and their corresponding fragility quotients. METHOD: A systematic search was conducted based on the Preferred Reporting Items for Systematic Reviews and Meta-analysis (PRISMA) guidelines which utilized MEDLINE, EMBASE, Cochrane Library and Web of Science databases. Inclusion criteria included RCTs related to the management of anal fistula published from 2000 to 2022 with dichotomous outcomes measures and 1:1 allocation. Calculation of FI and RFI was performed by creating 2 × 2 contingency tables by successively changing one nonevent to an event for each outcome measure until the result was made nonsignificant or significant, respectively. The Fragility Quotients were calculated by dividing the FI or RFI by the total sample size. Fragile results were defined as those with a FI or RFI equal to or less than the number of patients lost to follow-up. Additionally, those with a FI or RFI less than 3 were also considered fragile. Studies were considered extremely fragile if FI was ≤1 or FQ was ≤0.01. RESULTS: There were 36 RCTs that met our criteria, with 3223 patients. Among these, 19 (53%) were positive RCTs (p < 0.005) and 17 (47%) were negative RCTs (p > 0.05). The median FI was 2 (0-5). The analysis by categorical subgroup showed a strong correlation between FI and the p-value (p = 0.000) and the number of events (p = 0.011). The median RFI was 5 (3.5-9.5) and the subgroup analysis showed a strong correlation between RFI and the p-value (p = 0.000), sample size (0.021) and number needed to treat/number needed to harm (0.000). We considered 63.2% of positive RCTs to be fragile and 35.3% of negative RCTs. CONCLUSIONS: In the present study we demonstrated the lack of robustness of study findings in published RCTs in the field of anal fistula.

Early outcomes from the Minimally Invasive Right Colectomy Anastomosis study (MIRCAST).

BACKGROUND: The impact of method of anastomosis and minimally invasive surgical technique on surgical and clinical outcomes after right hemicolectomy is uncertain. The aim of the MIRCAST study was to compare intracorporeal and extracorporeal anastomosis (ICA and ECA respectively), each using either a laparoscopic approach or robot-assisted surgery during right hemicolectomies for benign or malignant tumours. METHODS: This was an international, multicentre, prospective, observational, monitored, non-randomized, parallel, four-cohort study (laparoscopic ECA; laparoscopic ICA; robot-assisted ECA; robot-assisted ICA). High-volume surgeons (at least 30 minimally invasive right colectomy procedures/year) from 59 hospitals across 12 European countries treated patients over a 3-year interval The primary composite endpoint was 30-day success, defined by two measures of efficacy-absence of surgical wound infection and of any major complication within the first 30 days after surgery. Secondary outcomes were: overall complications, conversion rate, duration of operation, and number of lymph nodes harvested. Propensity score analysis was used for comparison of ICA with ECA, and robot-assisted surgery with laparoscopy. RESULTS: Some 1320 patients were included in an intention-to-treat analysis (laparoscopic ECA, 555; laparoscopic ICA, 356; robot-assisted ECA, 88; robot-assisted ICA, 321). No differences in the co-primary endpoint at 30 days after surgery were observed between cohorts (7.2 and 7.6 per cent in ECA and ICA groups respectively; 7.8 and 6.6 per cent in laparoscopic and robot-assisted groups). Lower overall complication rates were observed after ICA, specifically less ileus, and nausea and vomiting after robot-assisted procedures. CONCLUSION: No difference in the composite outcome of surgical wound infections and severe postoperative complications was found between intracorporeal versus extracorporeal anastomosis or laparoscopy versus robot-assisted surgery.

The efficacy of porcine dermal collagen to treat complex anal fistulae: results of a multicenter cohort

Introduction: The management of complex anal fistulae remains a topical surgical problem. The choice and success of surgical management are based on the balance between healing and continence. Although porcine dermal collagen (Permacol Collagen Paste [PCP]- Covidien plc, Gosport, Hampshire, UK) represents a new generation of non-solid biomaterials, its results in anal fistulae are mixed. Methods: A multicenter observational retrospective analysis of consecutive patients with cryptoglandular anal fistula treated in four colorectal surgery units was performed between 2015 and 2020. Clinical cure of the fistula was the main outcome measure. Adverse events and alterations in anal continence were secondary outcomes. Results: The study included 119 patients (87 males, 71.1%), with a mean age of 53 years (IR 44-65). Most patients had complex (80.6%) and recurrent (91.6%) fistulae. With the first PCP treatment, the overall cure rate was 41.2% (49 patients) and 45.4% with the second treatment (5 out of 17 patients). The mean follow-up period was 17 months (IR 5-25). Healing was not affected by the location and type of fistula, the existence or not of a cavity, the number of tracts, or the administration of prophylactic antibiotics. After the PCP treatment, no patient in the series had worsening of continence. Morbidity affected 22.7% of the patients (27), with postoperative abscesses being the most frequent adverse event. There were no statistical differences between the four hospitals studied. Conclusions: Permacol collagen paste is a safe and easily reproducible therapy for complicated anal fistulae that has moderate efficacy. The overall success rate is slightly over 40%, with no detriment to fecal continence. (AU)

Exactitud diagnóstica en el cáncer de esófago localizado. Estudio observacional retrospectivo.

OBJECTIVE: To assess the accuracy of the diagnostic tests for a correct clinical tumor staging in localized esophageal cancer (EC). METHOD: Retrospective observational study of patients who underwent esophagectomy for cancer in a referral hospital between January 2003 and September 2019. Those patients who received neoadjuvant treatment were excluded in order to avoid bias from downstaging effects. The preoperative stage was compared with the pathological stage of the surgical specimen. Computed tomography (CT) , endoscopic ultrasound (EUS) and positron emission tomography (PET) were evaluated. The pT stage was correlated with the tumor length described in the esophagram (EG). RESULTS: Among the 63 patients included, the clinical staging was correct in 16 (global accuracy 25.4%), it was overstaged in 21 (33.2%) and understaged in 26 (41.3%). For cT staging, the accuracy of EUS was higher than that of CT (46.6% and 34.9%, respectively), specially for early stages. EG tumor length correlated with pT stage (p < 0.05). For cN staging, PET had the highest sensitivity (50.0%) and negative predictive value (75.0%). CONCLUSIONS: Despite the multiple diagnostic tools used, the global accuracy of clinical staging in localized EC is still a challenge. The lack of a test that stands out significantly from the others reinforces the need to use them in a complementary way.

OBJETIVO: Evaluar la exactitud diagnóstica para el estadiaje clínico del cáncer de esófago (CE) localizado. MÉTODO: Estudio observacional retrospectivo de los pacientes esofagectomizados por CE en un hospital de referencia entre enero de 2003 y septiembre de 2019. Se excluyeron aquellos que recibieron neoadyuvancia para evitar sesgos de infraestadiaje. Se comparó el estadio preoperatorio con el estadio patológico de la pieza quirúrgica. Se evaluaron la tomografía computarizada (TC), la ecoendoscopia (EUS) y la tomografía por emisión de positrones (PET). El estadio pT se correlacionó con la longitud tumoral descrita en el esofagograma (EG). RESULTADOS: De los 63 pacientes incluidos, el estadiaje clínico fue correcto en 16 (exactitud 25.4%), con sobreestadiaje en 21 (33.2%) e infraestadiaje en 26 (41.3%). Para el estadiaje cT, la EUS fue superior a la TC (exactitud 46.6% y 34.9%, respectivamente), en especial para estadios precoces. La longitud tumoral del EG se correlacionó con el estadio pT (p < 0.05). Para el estadiaje cN, la PET tuvo la mayor sensibilidad (50.0%) y el mayor valor predictivo negativo (75.0%). CONCLUSIONES: A pesar de las múltiples herramientas diagnósticas empleadas, la exactitud diagnóstica en el CE localizado es limitada. La ausencia de una prueba que destaque de manera significativa refuerza la necesidad de emplearlas de forma complementaria.

Subcuticular suture and incisional surgical-site infection in elective hepatobiliary and pancreatic surgery: an open-label, pragmatic randomized clinical trial (CLOSKIN trial).

BACKGROUND: Subcuticular suture has proven to reduce superficial incisional SSI (si-SSI) in clean surgery. However, question remains regarding clean-contaminated procedures. The aim of this study is to assess if subcuticular suture is superior to staples in reducing si-SSI incidence in elective HBP surgery. METHODS: Single-centre, open-label, parallel, pragmatic randomized clinical trial conducted at a referral tertiary Hospital between January 2020 and April 2022. Patients eligible for elective HBP surgery were randomly assigned (1:1) to subcuticular suture or surgical staples wound closure using a minimisation method based on previously confirmed risk factors. The primary endpoint was the incidence of si-SSI. Considered secondary endpoints were major postoperative morbidity in both groups, additional wound complications, median hospital length of stay and need for re-hospitalisation. RESULTS: Of the 379 patients, 346 patients were randomly assigned to receive skin closure with staples (n = 173) or subcuticular suture (n = 173). After further exclusion of 11 participants, 167 and 168 patients, respectively in the control and the experimental group received their allocated intervention. For the primary endpoint, no significant differences in si-SSI rate were found: 17 (9.82%) staples group vs. 8 (4.62%) in subcuticular suture group (p = 0.062). Subset analysis confirmed absence of significant differences. As for secondary endpoints, overall wound complications did not differ significantly between two procedures: 19 (10.98%) vs. 10 (6.35%) (p = 0.127). There were no treatment related adverse events. However, occurrence of si-SSI contributed to major postoperative morbidity in both groups (p < 0.001 and p = 0.018) and to a substantially prolonged postoperative hospitalization (p = 0.015). CONCLUSIONS: Subcuticular suture might offer a relative benefit for skin closure reducing incidence of si-SSI after elective HBP surgery, although this was found not to be clinically relevant. Yet, this should not be interpreted as equivalence among both treatments. Therefore, wound closure strategy should not be based only on these grounds. TRIAL REGISTRATION NUMBER: ISRCTN Registry number ISRCTN37315612 (registration date: 14/01/2020).

Care burden and outcome of the surgical management of ulcerative colitis: A retrospective analysis of the last 20 years in a tertiary hospital in Spain.

AIM: To analyze the surgical burden of UC care in the last two decades, analyzing the characteristics of the patients, surgical indications along with the short and long-term results. METHOD: Single-center retrospective cohort analysis of UC patients undergoing abdominal and anorectal surgery between January 2000 and December 2020. The care burden, clinical data and results were analyzed according to distribution by decades. RESULTS: 128 patients, 37% female, underwent 376 surgical interventions (296 intestinal procedures and 80 anorectal). Mean follow-up for the cohort was 106±64 months. Timing from diagnosis to first surgery was under 5 years in 53.3%. In the second decade of the study there were fewer operated patients (73 vs. 48) as well as the total number of interventions per patient (2.7 vs. 2.0). The proportion between elective and urgent surgery was reversed in the second decade, observing an increase in laparoscopic surgery (70% vs. 8%) together with a decrease in major postoperative morbidity (Clavien-Dindo≥IIIa) (20% vs 8.4%). 80 patients underwent a restorative proctocolectomy, with a failure of 5% at 1 year but 23.7% in the long term. 37 patients required anorectal surgery, of which 26 (71%) were serial interventions, most due to septic complications of the pouches. CONCLUSIONS: The number of colectomies and interventions per patient decreased in the last decade, while there were improvements in morbidity and surgical approach. The need for sequential surgeries and long-term active instrumental surveillance for possible functional deterioration constitutes a significant clinical burden.

Care burden and outcome of the surgical management of ulcerative colitis: A retrospective analysis of the last 20 years in a tertiary hospital in Spain / Carga asistencial y resultados del tratamiento quirúrgico de la colitis ulcerativa: un análisis retrospectivo de los últimos 20 años en un hospital terciario de España

Aim: To analyze the surgical burden of UC care in the last two decades, analyzing the characteristics of the patients, surgical indications along with the short and long-term results. Method: Single-center retrospective cohort analysis of UC patients undergoing abdominal and anorectal surgery between January 2000 and December 2020. The care burden, clinical data and results were analyzed according to distribution by decades. Results: 128 patients, 37% female, underwent 376 surgical interventions (296 intestinal procedures and 80 anorectal). Mean follow-up for the cohort was 106±64 months. Timing from diagnosis to first surgery was under 5 years in 53.3%. In the second decade of the study there were fewer operated patients (73 vs. 48) as well as the total number of interventions per patient (2.7 vs. 2.0). The proportion between elective and urgent surgery was reversed in the second decade, observing an increase in laparoscopic surgery (70% vs. 8%) together with a decrease in major postoperative morbidity (Clavien-Dindo≥IIIa) (20% vs 8.4%). 80 patients underwent a restorative proctocolectomy, with a failure of 5% at 1 year but 23.7% in the long term. 37 patients required anorectal surgery, of which 26 (71%) were serial interventions, most due to septic complications of the pouches. Conclusions: The number of colectomies and interventions per patient decreased in the last decade, while there were improvements in morbidity and surgical approach. The need for sequential surgeries and long-term active instrumental surveillance for possible functional deterioration constitutes a significant clinical burden. (AU)

Objetivo: Analizar la carga quirúrgica asistencial por CU en 20 años, analizando las características de los pacientes, indicaciones quirúrgicas y resultados a corto y largo plazo. Método: Análisis retrospectivo unicéntrico de pacientes intervenidos de enero del 2000 a diciembre del 2020. La carga asistencial, los datos clínicos y los resultados se analizaron según distribución por décadas. Resultados: Ciento veintiocho pacientes, 37% mujeres, con 376 intervenciones quirúrgicas (296 procedimientos intestinales y 80 anorrectales). El seguimiento medio de la cohorte fue de 106±64 meses. El lapso entre el diagnóstico y la primera cirugía fue <5 años en el 53,3%. En la segunda década del estudio hubo menos pacientes operados (73 frente a 48) y un menor número de intervenciones por paciente (2,7 frente a 2,0). La proporción entre cirugía electiva y urgente se revirtió en la segunda década, observándose un aumento de la cirugía laparoscópica (70% vs. 8%) junto con una disminución de la morbilidad postoperatoria mayor (Clavien-Dindo≥IIIa) (20% vs 8.4%). Se realizó una proctocolectomía restauradora a 80 pacientes, con un fracaso al año del 5% pero del 23,7% a largo plazo. Treinta y siete pacientes requirieron cirugía anorrectal, de los cuales 26 (71%) fueron intervenciones seriadas, la mayoría por complicaciones sépticas de los reservorios. Conclusiones: El número de colectomías y de intervenciones por paciente disminuyó en la última década, a la vez que hubo mejorías en la morbilidad y el abordaje quirúrgico. La necesidad de cirugías secuenciales y de una vigilancia instrumental activa a largo plazo por el posible deterioro funcional constituye una importante carga clínica. (AU)

Care burden and outcome of the surgical management of ulcerative colitis: A retrospective analysis of the last 20 years in a tertiary hospital in Spain / Carga asistencial y resultados del tratamiento quirúrgico de la colitis ulcerativa: un análisis retrospectivo de los últimos 20 años en un hospital terciario de España

Aim: To analyze the surgical burden of UC care in the last two decades, analyzing the characteristics of the patients, surgical indications along with the short and long-term results. Method: Single-center retrospective cohort analysis of UC patients undergoing abdominal and anorectal surgery between January 2000 and December 2020. The care burden, clinical data and results were analyzed according to distribution by decades. Results: 128 patients, 37% female, underwent 376 surgical interventions (296 intestinal procedures and 80 anorectal). Mean follow-up for the cohort was 106±64 months. Timing from diagnosis to first surgery was under 5 years in 53.3%. In the second decade of the study there were fewer operated patients (73 vs. 48) as well as the total number of interventions per patient (2.7 vs. 2.0). The proportion between elective and urgent surgery was reversed in the second decade, observing an increase in laparoscopic surgery (70% vs. 8%) together with a decrease in major postoperative morbidity (Clavien-Dindo≥IIIa) (20% vs 8.4%). 80 patients underwent a restorative proctocolectomy, with a failure of 5% at 1 year but 23.7% in the long term. 37 patients required anorectal surgery, of which 26 (71%) were serial interventions, most due to septic complications of the pouches. Conclusions: The number of colectomies and interventions per patient decreased in the last decade, while there were improvements in morbidity and surgical approach. The need for sequential surgeries and long-term active instrumental surveillance for possible functional deterioration constitutes a significant clinical burden. (AU)

Objetivo: Analizar la carga quirúrgica asistencial por CU en 20 años, analizando las características de los pacientes, indicaciones quirúrgicas y resultados a corto y largo plazo. Método: Análisis retrospectivo unicéntrico de pacientes intervenidos de enero del 2000 a diciembre del 2020. La carga asistencial, los datos clínicos y los resultados se analizaron según distribución por décadas. Resultados: Ciento veintiocho pacientes, 37% mujeres, con 376 intervenciones quirúrgicas (296 procedimientos intestinales y 80 anorrectales). El seguimiento medio de la cohorte fue de 106±64 meses. El lapso entre el diagnóstico y la primera cirugía fue <5 años en el 53,3%. En la segunda década del estudio hubo menos pacientes operados (73 frente a 48) y un menor número de intervenciones por paciente (2,7 frente a 2,0). La proporción entre cirugía electiva y urgente se revirtió en la segunda década, observándose un aumento de la cirugía laparoscópica (70% vs. 8%) junto con una disminución de la morbilidad postoperatoria mayor (Clavien-Dindo≥IIIa) (20% vs 8.4%). Se realizó una proctocolectomía restauradora a 80 pacientes, con un fracaso al año del 5% pero del 23,7% a largo plazo. Treinta y siete pacientes requirieron cirugía anorrectal, de los cuales 26 (71%) fueron intervenciones seriadas, la mayoría por complicaciones sépticas de los reservorios. Conclusiones: El número de colectomías y de intervenciones por paciente disminuyó en la última década, a la vez que hubo mejorías en la morbilidad y el abordaje quirúrgico. La necesidad de cirugías secuenciales y de una vigilancia instrumental activa a largo plazo por el posible deterioro funcional constituye una importante carga clínica. (AU)

Prognostic Value of the Circumferential Resection Margin After Curative Surgery for Rectal Cancer: A Multicenter Propensity Score-Matched Analysis.

BACKGROUND: Recently, positive circumferential resection margin has been found to be an indicator of advanced disease with a high risk of distant recurrence rather than local recurrence. OBJECTIVE: The study aimed to analyze the prognostic impact of the circumferential resection margin on long-term oncological outcomes in patients with rectal cancer. DESIGN: This was a multicenter, propensity score-matched (2:1) analysis comparing the positive and negative circumferential resection margins. SETTINGS: The study was conducted at 5 high-volume centers in Spain. PATIENTS: Patients who underwent total mesorectal excision with curative intent for middle-low rectal cancer between 2006 and 2014 were included. MAIN OUTCOME MEASURES: The main outcomes were local recurrence, distant recurrence, overall survival, and disease-free survival. RESULTS: The unmatched initial cohort consisted of 1599 patients, of whom 4.9% had a positive circumferential resection margin. After matching, 234 patients were included (156 with a negative circumferential margin and 78 with a positive circumferential margin). The median follow-up period was 52.5 (22.0-69.5) months. Local recurrence was significantly higher in patients with a positive circumferential margin (33.3% vs 11.5%; p < 0.001). Distant recurrence was similar in both groups (46.2% vs 42.3%; p = 0.651). There were no statistically significant differences in 5-year overall survival (48.6% vs 43.6%; p = 0.14). Disease-free survival was lower in patients with a positive circumferential margin (36.1% vs 52.3%; p = 0.026). LIMITATIONS: This study was limited by its retrospective design. The different neoadjuvant treatment options were not included in the propensity score. CONCLUSIONS: The positive circumferential resection margin was associated with a higher local recurrence rate and worse disease-free survival in comparison with the negative circumferential resection margin. However, the positive circumferential resection margin was not a prognostic indicator of distant recurrence and overall survival. See Video Abstract at http://links.lww.com/DCR/B950 . VALOR PRONSTICO DEL MARGEN DE RESECCIN CIRCUNFERENCIAL DESPUS DE LA CIRUGA CURATIVA PARA EL CNCER DE RECTO UN ANLISIS MULTICNTRICO EMPAREJADO POR PUNTAJE DE PROPENSIN: ANTECEDENTES:En los últimos años, se ha encontrado que el margen de resección circunferencial positivo es un indicador de enfermedad avanzada con alto riesgo de recurrencia a distancia más que de recurrencia local.OBJETIVO:El objetivo fue analizar el impacto pronóstico del margen de resección circunferencial sobre la recidiva local, a distancia y las tasas de supervivencia en pacientes con cáncer de recto.DISEÑO:Este fue un análisis multicéntrico emparejado por puntaje de propensión 2: 1 que comparó el margen de resección circunferencial positivo y negativo.AJUSTES:El estudio se realizó en 5 centros Españoles de alto volumen.PACIENTES:Se incluyeron pacientes sometidos a escisión total de mesorrecto con intención curativa por cáncer de recto medio-bajo entre 2006-2014. Las características clínicas e histológicas se utilizaron para el emparejamiento.PRINCIPALES MEDIDAS DE RESULTADO:Los resultadoes principales fueron la recurrencia local, la recurrencia a distancia, la supervivencia global y libre de enfermedad.RESULTADOS:La cohorte inicial no emparejada consistió en 1599 pacientes; El 4,9% tuvo un margen de resección circunferencial positivo. Tras el emparejamiento se incluyeron 234 pacientes (156 con margen circunferencial negativo y 78 con margen circunferencial positivo). La mediana del período de seguimiento fue de 52,5 meses (22,0-69,5). La recurrencia local fue significativamente mayor en pacientes con margen circunferencial positivo, 33,3% vs 11,5% [HR 3,2; IC 95%: 1,83-5,43; p < 0,001]. La recidiva a distancia fue similar en ambos grupos (46,2 % frente a 42,3 %) [HR 1,09, IC 95 %: 0,78-1,90; p = 0,651]. No hubo diferencias significativas en la supervivencia global a 5 años (48,6 % frente a 43,6 %) [HR 1,09, IC 95 %: 0,92-1,78; p = 0,14]; La supervivencia libre de enfermedad fue menor en pacientes con margen circunferencial positivo, 36,1% vs 52,3% [HR 1,5; IC 95%: 1,05-2,06; p = 0,026].LIMITACIONES:Este estudio estuvo limitado por el diseño retrospectivo. Las diferentes opciones de tratamientos neoadyuvantes no se han incluido en la puntuación de propensión.CONCLUSIONES:El margen de resección circunferencial positivo se asocia con una mayor tasa de recurrencia local y peor supervivencia libre de enfermedad en comparación con el margen de resección circunferencial negativo. Sin embargo, el margen de resección circunferencial positivo no fue un indicador pronóstico de recidiva a distancia ni de supervivencia global. Consulte el Video del Resumen en http://links.lww.com/DCR/B950 . (Traducción- Dr. Yesenia Rojas-Khalil ).

Características y resultados oncológicos del carcinoma epidermoide de ano: análisis comparativo entre los pacientes inmunocompetentes y los inmunodeprimidos / Characteristics and oncological results of epidermoid anal carcinoma: Comparison analysis between immunocompetent and immunosuppressed patients

Objetivos: La mayoría de los ensayos clínicos realizados sobre pacientes con cáncer escamoso anal (CEA) excluyen pacientes inmunodeprimidos. El objetivo del presente estudio es comparar las características y los resultados oncológicos entre pacientes con CEA inmunocomprometidos e inmunocompetentes. Métodos: Estudio multicéntrico comparativo retrospectivo que incluye 2 cohortes consecutivas de pacientes, inmunocomprometidos e inmunocompetentes, diagnosticados de carcinoma escamoso anal. Se han investigado las características de los pacientes, los tratamientos realizados, la respuesta clínica al tratamiento con quimiorradioterapia (QRT), la recidiva local o a distancia, la supervivencia global (SG) y la supervivencia libre de enfermedad (SLE). Resultados: De enero 2012 a diciembre 2017 hemos estudiado a 84 pacientes, 47 (55,6%) mujeres, afectos de CEA, de los cuales 22 (26%) han sido pacientes inmunocomprometidos y 62 (74%) inmunocompetentes. Los pacientes inmunocomprometidos fueron más jóvenes (53 vs. 61 años; p=0,001), con un menor tamaño tumoral (p=0,044), y presentaban un mayor consumo de tabaco (p=0,034) y de drogas de uso parenteral (p=0,001). No se objetivaron diferencias significativas en los tratamientos administrados (p=0,301), tampoco difirió la respuesta clínica a la QRT (83 vs. 100%). Tampoco se observaron diferencias significativas en la supervivencia global (60 vs. 64%; p=0,756) o en la supervivencia libre de enfermedad a 5 años (SLE) (65 vs. 68%; p=0,338). Conclusiones: En el presente estudio no se observaron diferencias significativas en relación con los resultados oncológicos a largo plazo entre pacientes inmunocompetentes e inmunocomprometidos diagnosticados de CEA, con un grado de cumplimiento del tratamiento similar. Esta evidencia podría deberse al estrecho seguimiento y buen control terapéutico de pacientes infectados por HIV. (AU)

Objective: Most evidence, including recent randomized controlled trials, analysing anal squamous cell carcinoma (SCC) do not consider immunocompromise patient population. The aim of this study was to compare clinical and oncological outcomes among immunocompetent and immunocompromised patients with anal squamous cell carcinoma. Method: Multicentric retrospective comparative study including 2 cohorts of consecutive patients, immunocompetent and immunocompromised, diagnosed with anal SCC. This study evaluated clinical characteristics, clinical response to radical chemoradiotherapy (CRT) and long-term oncological results including both local and distant recurrence, overall survival (OS) and disease-free survival (DFS). Results: A total of 84 patients, 47 (55.6%) female, diagnosed with anal SCC from January 2012 to December 2017 were included, 22 (26%) and 62 (74%) patients in immunocompromised and immunocompetent groups respectively. Patients in immunocompromised group were significantly younger (53 vs. 61 years; P=0.001), with smaller tumoral size (P=0.044) and reported higher rates of substance abuse.including tobacco use (P=0.034) and parenteral drug consumption (P=0.001). No differences were found in administered therapies (P=301) neither in clinical response to chemoradiotherapy (83 vs. 100%). Moreover, similar 5-year OS (60 vs. 64%; P=0.756) and DFS (65 vs. 68%; P=0.338) were observed. Conclusion: The present study shows no significant differences in long-term oncological results among immunocompetent and immunocompromised patients diagnosed with anal SCC, with a similar oncologic treatment. This evidence might be explained due to the close monitoring and adequate therapeutic control of HIV positive patients. (AU)

Estadiaje ganglionar en el adenocarcinoma gástrico / Lymph node stage in gastric adenocarcinoma

Resumen Objetivos: El sistema linfático del estómago es complejo y multidireccional, siendo difícil predecir el patrón de diseminación linfática en el adenocarcinoma (ADC) gástrico. Los objetivos de este trabajo son determinar si el analizar los grupos ganglionares de la pieza quirúrgica por separado tiene implicaciones en el estadiaje, además estudiar la afectación de diferentes grupos ganglionares. Materials y Método: Estudio observacional retrospectivo de pacientes intervenidos de gastrectomía y linfadenectomía con intención curativa por ADC en un hospital de referencia (2017-2021).,_Se han comparado aquellos pacientes cuya pieza quirúrgica se estudió en su totalidad (grupo A) con aquellos en los que se separaron los grupos ganglionares para su análisis (grupo B). En el grupo B, se ha analizado la afectación ganglionar de diferentes grupos ganglionares en base a la localización tumoral y el estadio pT. Resultados: Se incluyeron 150 pacientes. La media de ganglios analizados fue significativamente mayor cuando se separaron los grupos ganglionares (grupo B) (24,01 respecto a 20,49). La afectación ganglionar fue del 45,8%, 58,3% y 55,5% en los tumores de tercio superior, medio e inferior respectivamente, y los grupos difirieron en base a la localización tumoral. El riesgo de afectación ganglionar fue significativamente mayor y hubo más grupos ganglionares perigástricos afectos cuanto mayor era el estadio pT. Conclusiones: Separar los grupos ganglionares previo a su análisis aumenta el número de ganglios analizados mejorando el estadiaje ganglionar. Existen diferentes rutas de drenaje linfático dependiendo de la localización tumoral y la afectación ganglionar aumenta de forma paralela al estadio pT.

Objectives: The lymphatic system of the stomach is complex and multidirectional, making it difficult to predict the pattern of lymphatic spread in gastric adenocarcinoma (GAC). The aim of this paper is to determine if analyzing the lymph node groups of the surgical specimen separately has implications in the pathological staging, as well as to study the involvement rate of different lymph node groups. Material and Method: Retrospective observational study of patients who underwent curative intent gastrectomy and lymphadenectomy for GAC in a reference hospital (2017-2021). Those patients whose surgical specimen was studied as a whole (group A) were compared with those in whom the lymph node groups were separated by surgeons before analysis (group B). In group B, the involvement of different lymph node groups was analyzed based on tumor location and pT stage. Results: 150 patients were included. The mean number of lymph nodes analyzed was significantly higher when the lymph node groups were separately analyzed (group B) (24.01 compared to 20.49). Lymph node involvement was 45.8%, 58.3%, and 55.5% in tumors of the upper, middle, and lower third, respectively, and the involved groups differed depending on the tumor location. The higher the pT stage was, the risk of lymph node involvement was significantly higher and there were more perigastric lymph node groups affected. Conclusions: Separating lymph node groups prior to their analysis increases the number of lymph nodes analyzed and therefore improves lymph node staging. There are different lymphatic drainage routes depending on the tumor location and lymph node involvement increases in parallel with the pT stage.

Characteristics and oncological results of epidermoid anal carcinoma: Comparison analysis between immunocompetent and immunosuppressed patients.

OBJECTIVE: Most evidence, including recent randomized controlled trials, analysing anal squamous cell carcinoma (SCC) do not consider immunocompromise patient population. The aim of this study was to compare clinical and oncological outcomes among immunocompetent and immunocompromised patients with anal squamous cell carcinoma. METHOD: Multicentric retrospective comparative study including 2 cohorts of consecutive patients, immunocompetent and immunocompromised, diagnosed with anal SCC. This study evaluated clinical characteristics, clinical response to radical chemoradiotherapy (CRT) and long-term oncological results including both local and distant recurrence, overall survival (OS) and disease-free survival (DFS). RESULTS: A total of 84 patients, 47 (55.6%) female, diagnosed with anal SCC from January 2012 to December 2017 were included, 22 (26%) and 62 (74%) patients in immunocompromised and immunocompetent groups respectively. Patients in immunocompromised group were significantly younger (53 vs. 61 years; P = 0.001), with smaller tumoral size (P = 0.044) and reported higher rates of substance abuse including tobacco use (P = 0.034) and parenteral drug consumption (P = 0.001). No differences were found in administered therapies (P = 301) neither in clinical response to chemoradiotherapy (83 vs. 100%). Moreover, similar 5-year OS (60 vs. 64%; P = 0.756) and DFS (65 vs. 68%; P = 0.338) were observed. CONCLUSION: The present study shows no significant differences in long-term oncological results among immunocompetent and immunocompromised patients diagnosed with anal SCC, with a similar oncologic treatment. This evidence might be explained due to the close monitoring and adequate therapeutic control of HIV positive patients.

Extended Versus Standard Complete Mesocolon Excision in Sigmoid Colon Cancer: A Multicenter Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to evaluate whether extended complete mesocolic excision (e-CME) for sigmoid colon cancer improves oncological outcomes without compromising morbidity or functional results. BACKGROUND: In surgery for cancer of the sigmoid colon and upper rectum, s-CME removes the lymphofatty tissue surrounding the inferior mesenteric artery (IMA), but not the lymphofatty tissue surrounding the portion of the inferior mesenteric vein that does not run parallel to the IMA. Evidence about the safety and efficacy of extending CME to include this tissue is lacking. METHODS: This single-blind study randomized sigmoid cancer patients at 4 centers to undergo e-CME or s-CME. The primary outcome was the total number of lymph nodes harvested. Secondary outcomes included disease-free and overall survival at 2 years, morbidity, and bowel and genitourinary function. Clinicaltrials.gov: NCT03107650. RESULTS: We analyzed 93 patients (46 e-CME and 47 s-CME). Perioperative outcomes were similar between groups. No differences between groups were found in the total number of lymph nodes harvested [21 (interquartile range, IQR, 14-29) in e-CME vs 20 (IQR, 15-27) in s-CME, P = 0.873], morbidity (P = 0.829), disease-free survival (P = 0.926), or overall survival (P = 0.564). The extended specimen yielded a median of 1 lymph node (range, 0-6), none of which were positive.Bowel function recovery was similar between arms at all timepoints. Males undergoing e-CME had worse recovery of urinary function (P = 0.026). CONCLUSION: Extending lymphadenectomy to include the IMV territory did not increase the number of lymph nodes or improve local recurrence or survival rates.

Incidencia y factores de riesgo para el desarrollo de colelitiasis tras cirugía bariátrica / Incidence and risk factors for de novo cholelithiasis after bariatric surgery

Introducción: La obesidad y la rápida pérdida de peso tras la cirugía bariátrica (CB) son factores de riesgo para la formación de colelitiasis. El objetivo de este trabajo es conocer la incidencia de colelitiasis de novo sintomática (CLNS) tras CB y analizar los factores de riesgo para su desarrollo. Métodos: Estudio observacional retrospectivo unicéntrico de los pacientes sometidos a CB entre enero de 2010 y diciembre de 2017. Se ha estudiado la incidencia de CLNS y se han analizado el género, la edad, las comorbilidades, la técnica quirúrgica, el IMC inicial y el porcentaje de exceso de IMC perdido (%EIMCP) al 6.°, 12.° y 24.° mes postoperatorio. Resultados: De los 415 pacientes intervenidos de CB, 280 han sido estudiados ya que no estaban colecistectomizados previamente y tenían una ecografía preoperatoria negativa para colelitiasis. Veintinueve desarrollaron CLNS (10,35%), con un aumento en la incidencia acumulada notablemente más alto durante el primer año postoperatorio (5%, IC 95% 2,4-7,6). Un mayor porcentaje de exceso de IMC perdido al 6.°, 12.° y 24.° mes postoperatorio se correlacionó de forma estadísticamente significativa con un mayor riesgo de CLNS. Conclusiones: La incidencia de CLNS y colecistectomía tras CB es relativamente alta, principalmente durante el periodo de pérdida de peso rápida, y más cuanto mayor sea el porcentaje de exceso de IMC perdido. La colecistectomía concomitante en caso de colelitiasis preoperatoria, independientemente de la sintomatología y el uso de ácido ursodesoxicólico durante el periodo de mayor riesgo para el desarrollo de CLNS, son dos opciones terapéuticas a tener en cuenta. (AU)

Introduction: Obesity and rapid weight loss after bariatric surgery (BS) are risk factors for the development of cholelitiasis. The aim of this study is to know the incidence of the de novo symptomatic cholelitiasis (DNSC) after BS and to analyze the risk factors for its development. Methods: Single-centre retrospective observational study of patients undergoing BS between January 2010 and December 2017. The incidence of DNSC has been studied and sex, age, comorbilities, surgical tecnique, initial BMI and percentage of excess BMI lost (%EIMCP) at 6th, 12th and 24th postoperative months have been analyzed. Results: Among the 415 patients who underwent BS, 280 have been studied since they were not previously cholecystectomized and had a preoperative negative abdominal ultrasound. Twenty-nine developed DNSC (10.35%), with a remarkably higher increase in cumulative incidence during the first postoperative year (5%, 95% CI 2,4-7,6). A higher percentage of excess BMI lost at the 6, 12 and 24 postoperative months was statistically significantly correlated with an increased risk of DNSC. Conclusions: Incidence of DNSC and cholecystectomy after BS are relatively high, mainly during rapid weight loss period and even more the higher the percentage of excess BMI lost is. Concomitant cholecystectomy during BS in case of preoperative cholelithiasis regardless of symptoms and the use of ursodeoxycholic acid during the period of greater risk for DNSC development are two therapeutic options to consider. (AU)