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.

Risk Factors for Microscopic Disease Positivity at Ileocolic Resection Margins for Crohn's Disease.

INTRODUCTION: Interest in microscopic margin positivity during surgical resection of medical-refractory Crohn's disease has been renewed with multiple recent studies showing an association between microscopic margin positivity with disease recurrence. Our aim was to determine risk factors for microscopic margin disease positivity following ileocolic resection (ICR). MATERIALS AND METHODS: A prospectively-maintained database of patients with Crohn's disease undergoing ICR at a tertiary-referral center was queried. Margin positivity was defined as the presence of cryptitis, erosion, transmural inflammation with lymphoid aggregates, or architectural distortion at either ileal (proximal) or colonic (distal) margins. RESULTS: Amongst 584 patients, 97 patients had a positive microscopic margin (17%) of which 46% had a positive proximal margin, 17% had a positive distal margin, and 13% had both positive and distal margins. Using multivariable logistic regression analysis, index ICR was associated with less odds of positive margin (odds ratio [OR] 0.46, 95% confidence interval [CI] 0.24-0.89, p=0.02), and granuloma presence was associated with increased odds (OR 2.26, 95% CI 1.23-4.21, p=0.01). CONCLUSION: We found that repeat ileocolic resection and granuloma presence were predictors of microscopic margin disease.

Blinded Intraoperative Quantitative Indocyanine Green Metrics Associate With Intestinal Margin Acceptance in Colorectal Surgery.

BACKGROUND: Indocyanine green is a useful tool in colorectal surgery. Quantitative values may enhance and standardize its application. OBJECTIVE: To determine whether quantitative indocyanine green metrics correlate with standard subjective indocyanine green perfusion assessment in acceptance or rejection of anastomotic margins. DESIGN: Prospective single-arm, single-institution cohort study. Surgeons viewed subjective indocyanine green images but were blinded to quantitative indocyanine green metrics. SETTING: Tertiary academic center. PATIENTS: Adults undergoing planned intestinal resection. MAIN OUTCOME MEASURES: Accepted perfusion and rejected perfusion of the intestinal margin were defined by the absence or presence of ischemia by subjective indocyanine green and gross inspection. The primary outcomes included quantitative indocyanine green values, maximum fluorescence, and time-to-maximum fluorescence in accepted compared to rejected perfusion. Secondary outcomes included maximum fluorescence and time-to-maximum fluorescence values in anastomotic leak. RESULTS: There were 89 perfusion assessments comprising 156 intestinal segments. Nine segments were subjectively assessed to have poor perfusion by visual inspection and subjective indocyanine green. Maximum fluorescence (% intensity) exhibited higher intensity in accepted perfusion (accepted perfusion 161% [82%-351%] vs rejected perfusion 63% [10%-76%]; p = 0.03). Similarly, time-to-maximum fluorescence (seconds) was earlier in accepted perfusion compared to rejected perfusion (10 seconds [1-40] vs 120 seconds [90-120]; p < 0.01). Increased BMI was associated with higher maximum fluorescence. Anastomotic leak did not correlate with maximum fluorescence or time-to-maximum fluorescence. LIMITATIONS: Small cohort study, not powered to measure the association between quantitative indocyanine green metrics and anastomotic leak. CONCLUSIONS: We demonstrated that blinded quantitative values reliably correlate with subjective indocyanine green perfusion assessment. Time-to-maximum intensity is an important metric in perfusion evaluation. Quantitative indocyanine green metrics may enhance intraoperative intestinal perfusion assessment. Future studies may attempt to correlate quantitative indocyanine green values with anastomotic leak. See Video Abstract . LAS MTRICAS CUANTITATIVAS INTRAOPERATORIAS CIEGAS DEL VERDE DE INDOCIANINA SE ASOCIAN CON LA ACEPTACIN DEL MARGEN INTESTINAL EN LA CIRUGA COLORRECTAL: ANTECEDENTES:El verde de indocianina es una herramienta útil en la cirugía colorrectal. Los valores cuantitativos pueden mejorar y estandarizar su aplicación.OBJETIVO:Determinar si las métricas cuantitativas de verde de indocianina se correlacionan con la evaluación subjetiva estándar de perfusión de verde de indocianina en la aceptación o rechazo de los márgenes anastomóticos.DISEÑO:Estudio de cohorte prospectivo de un solo brazo y de una sola institución. Los cirujanos vieron imágenes subjetivas de verde de indocianina, pero no conocían las métricas cuantitativas de verde de indocianina.AJUSTE:Centro académico terciario.PACIENTES:Adultos sometidos a resección intestinal planificada.PRINCIPALES MEDIDAS DE RESULTADO:La perfusión aceptada y la perfusión rechazada del margen intestinal se definieron por la ausencia o presencia de isquemia mediante verde de indocianina subjetiva y la inspección macroscópica. Los resultados primarios fueron los valores cuantitativos de verde de indocianina, la fluorescencia máxima y el tiempo hasta la fluorescencia máxima en la perfusión aceptada en comparación con la rechazada. Los resultados secundarios incluyeron la fluorescencia máxima y el tiempo hasta alcanzar los valores máximos de fluorescencia en la fuga anastomótica.RESULTADOS:Se realizaron 89 evaluaciones de perfusión, comprendiendo 156 segmentos intestinales. Se evaluó subjetivamente que 9 segmentos tenían mala perfusión mediante inspección visual y verde de indocianina subjetiva. La fluorescencia máxima (% de intensidad) mostró una mayor intensidad en la perfusión aceptada [Perfusión aceptada 161% (82-351) vs Perfusión rechazada 63% (10-76); p = 0,03]. De manera similar, el tiempo hasta la fluorescencia máxima (segundos) fue más temprano en la perfusión aceptada en comparación con la rechazada [10 s (1-40) frente a 120 s (90-120); p < 0,01]. Aumento del índice de masa corporal asociado con una fluorescencia máxima más alta. La fuga anastomótica no se correlacionó con la fluorescencia máxima ni con el tiempo hasta la fluorescencia máxima.LIMITACIONES:Estudio de cohorte pequeño, sin poder para medir la asociación entre las mediciones cuantitativas del verde de indocianina y la fuga anastomótica.CONCLUSIÓN:Demostramos que los valores cuantitativos ciegos se correlacionan de manera confiable con la evaluación subjetiva de la perfusión de verde de indocianina. El tiempo hasta la intensidad máxima es una métrica importante en la evaluación de la perfusión. Las métricas cuantitativas de verde de indocianina pueden mejorar la evaluación de la perfusión intestinal intraoperatoria. Los estudios futuros pueden intentar correlacionar los valores cuantitativos de verde de indocianina con la fuga anastomótica. (Traducción-Dr. Yolanda Colorado).

Multicenter phase II trial of transanal total mesorectal excision for rectal cancer: preliminary results.

BACKGROUND: Transanal TME (taTME) combines abdominal and transanal dissection to facilitate sphincter preservation in patients with low rectal tumors. Few phase II/III trials report long-term oncologic and functional results. We report early results from a North American prospective multicenter phase II trial of taTME (NCT03144765). METHODS: 100 patients with stage I-III rectal adenocarcinoma located ≤ 10 cm from the anal verge (AV) were enrolled across 11 centers. Primary and secondary endpoints were TME quality, pathologic outcomes, 30-day and 90-day outcomes, and stoma closure rate. Univariable regression analysis was performed to assess risk factors for incomplete TME and anastomotic complications. RESULTS: Between September 2017 and April 2022, 70 males and 30 females with median age of 58 (IQR 49-62) years and BMI 27.8 (IQR 23.9-31.8) kg/m2 underwent 2-team taTME for tumors located a median 5.8 (IQR 4.5-7.0) cm from the AV. Neoadjuvant radiotherapy was completed in 69%. Intersphincteric resection was performed in 36% and all patients were diverted. Intraoperative complications occurred in 8% including 3 organ injuries, 2 abdominal and 1 transanal conversion. The 30-day and 90-day morbidity rates were 49% (Clavien-Dindo (CD) ≥ 3 in 28.6%) and 56% (CD ≥ 3 in 30.4% including 1 mortality), respectively. Anastomotic complications were reported in 18% including 10% diagnosed within 30 days. Higher anastomotic risk was noted among males (p = 0.05). At a median follow-up of 5 (IQR 3.1-7.4) months, 98% of stomas were closed. TME grade was complete or near complete in 90%, with positive margins in 2 cases (3%). Risk factors for incomplete TME were ASA ≥ 3 (p = 0.01), increased time between NRT and surgery (p = 0.03), and higher operative blood loss (p = 0.003). CONCLUSION: When performed at expert centers, 2-team taTME in patients with low rectal tumors is safe with low conversion rates and high stoma closure rate. Mid-term results will further evaluate oncologic and functional outcomes.

Prospective Randomized Trial of Immediate Postoperative Use of Regular Diet Versus Clear Liquid Diet in Major Colorectal Surgery.

BACKGROUND: Enhanced recovery protocols are becoming standard practice after major colorectal surgery. An increasing body of evidence suggests that early feeding should be encouraged; however, whether a clear liquid diet or solid diet should be given immediately after surgery is undetermined. OBJECTIVE: Evaluate whether regular diet was superior to clear liquid diet beginning on postoperative day 0 after major colorectal surgery. DESIGN: Superiority trial design. SETTING: Urban tertiary center. PATIENTS: Consecutive patients undergoing abdominal colorectal surgery from September 2017 to June 2018. INTERVENTIONS: Eligible patients received either 1) clear liquid diet on postoperative day 0 with advancement to regular diet on postoperative day 1 or 2) regular diet on postoperative day 0 and continuing for the duration of patients' recovery. MAIN OUTCOME MEASURES: The primary end point was diet tolerance, defined by the absence of vomiting by postoperative day 2. RESULTS: A total of 105 patients were randomly assigned with 53 in the clear liquid diet group and 52 in the regular diet group. All randomly assigned patients were included in the analysis. The rate of diet tolerance by postoperative day 2 was similar between groups. Rates of ileus, antiemetic usage, narcotic usage, time to return of bowel function, and pain/nausea/bloating scores were similar between the 2 groups. Significantly more patients in the clear liquid diet group (91%) tolerated their diet than did the regular diet group (71%) on postoperative day 0 ( p = 0.01). LIMITATIONS: Diet tolerance was only monitored during inpatient stay. The rate of postoperative ileus was difficult to capture as its clinical definition encompassed a wide range of symptoms. CONCLUSIONS: Regular diet immediately after abdominal colorectal surgery was not superior to a clear liquid diet with respect to diet tolerance by postoperative day 2. Furthermore, starting regular diet on postoperative day 0 was not associated with any outcome benefits compared to clear liquid diet. ENSAYO PROSPECTIVO ALEATORIZADO SOBRE EL USO POSTOPERATORIO INMEDIATO DE UNA DIETA NORMAL VERSUS UNA DIETA DE LQUIDOS CLAROS EN CIRUGAS MAYORES COLORRECTALES: ANTECEDENTES:Los protocolos de recuperación mejorada se están convirtiendo en una práctica estandarizada tras una cirugía mayor colorrectal. La creciente evidencia sugiere la alimentación temprana debe ser estimulada, sin embargo, no se ha determinado si se debe administrar una dieta de líquidos claros o una dieta sólida inmediatamente después de la cirugía.OBJETIVO:Evaluar si la dieta regular fue superior a la dieta de líquidos claros a partir del día cero del postoperatorio tras una cirugía mayor colorrectal.DISEÑO:Diseño de prueba de superioridad.AJUSTE:Centro terciario urbano.PACIENTES:Pacientes consecutivos sometidos a cirugía abdominal colorrectal desde septiembre de 2017 hasta junio de 2018INTERVENCIONES:Los pacientes elegibles recibieron ya sea 1) dieta de líquidos claros en el día 0 del postoperatorio con avance a la dieta regular en el día 1 del postoperatorio o 2) dieta regular en el día 0 del postoperatorio y continuaron durante la recuperación de los pacientes.PRINCIPALES MEDIDAS DE RESULTADO:El criterio principal de valoración fue la tolerancia a la dieta, definida por la ausencia de vómitos en el segundo día posoperatorio.RESULTADOS:Un total de 105 pacientes fueron aleatorizados con 53 en el grupo de dieta de líquidos claros y 52 en el grupo de dieta regular. Todos los pacientes aleatorizados fueron incluidos en el análisis. La tasa de tolerancia a la dieta en el segundo día postoperatorio fue similar entre los grupos. Las tasas de íleo, del uso de antieméticos, del uso de narcóticos, del tiempo de recuperación de la función intestinal y puntajes de dolor/náuseas/distensión abdominal fueron similares entre los dos grupos. Significativamente más pacientes en el grupo de dieta de líquidos claros (91%) toleraron su dieta comparada al grupo de dieta regular (71%) en el día postoperatorio 0 ( p = 0,01).LIMITACIONES:La tolerancia a la dieta solo fue monitorizada durante la estadía hospitalaria. La tasa de íleo postoperatorio fue difícil de registrar debido a que su definición clínica abarcaba una amplia variedad de síntomas.CONCLUSIONES:La dieta regular inmediatamente después de la cirugía abdominal colorrectal no fue superior a una dieta de líquidos claros con respecto a la tolerancia de la dieta en el día 2 del postoperatorio. Además, comenzar una dieta regular el día cero del postoperatorio no se asoció con ningún beneficio en los resultados en comparación con la dieta de líquidos claros. (Traducción-Dr. Osvaldo Gauto ).

Discordance in Total Mesorectal Excision Specimen Grading in a Prospective Phase 2 Multicenter Rectal Cancer Trial: Are We Overestimating the Quality of Our Resections?

OBJECTIVES: To report the results of a rigorous quality control (QC) process in the grading of total mesorectal excision (TME) specimens during a multicenter prospective phase 2 trial of transanal TME. BACKGROUND: Grading of TME specimens is based on the macroscopic assessment of the mesorectum and standardized through synoptic pathology reporting. TME grade is a strong predictor of outcomes with incomplete (IC) TME associated with increased rates of local recurrence relative to complete or near complete (NC) TME. Although TME grade serves as an endpoint in most rectal cancer trials, in protocols incorporating centralized review of TME specimens for quality assurance, discordance in grading and the management thereof has not been previously described. METHODS: A phase 2 prospective transanal TME trial was conducted from 2017 to 2022 across 11 North American centers with TME quality as the primary study endpoint. QC measures included (1) training of site pathologists in TME protocols, (2) blinded grading of de-identified TME specimen photographs by central pathologists, and (3) reconciliation of major discordance before trial reporting. Cohen Kappa statistic was used to assess agreement in grading. RESULTS: Overall agreement in grading of 100 TME specimens between site and central reviewer was rated as fair, (κ = 0.35; 95% CI: 0.10-0.61; P < 0.0001). Concordance was noted in 54%, with minor and major discordance in 32% and 14% of cases, respectively. Upon reconciliation, 13/14 (93%) major discordances were resolved. Pre versus postreconciliation rates of complete or NC and IC TME are 77%/16% and 7% versus 69%/21% and 10%. Reconciliation resulted in a major upgrade (IC-NC; N = 1) or major downgrade (NC/C-IC, N = 4) in 5 cases overall (5%). CONCLUSIONS: A 14% rate of major discordance was observed in TME grading between the site and central reviewers. The resolution resulted in a major change in final TME grade in 5% of cases, which suggests that reported rates or TME completeness are likely overestimated in trials. QC through a central review of TME photographs and reconciliation of major discordances is strongly recommended.

POLE-Mutant Colon Cancer Treated with PD-1 Blockade Showing Clearance of Circulating Tumor DNA and Prolonged Disease-Free Interval.

Colon cancer with high microsatellite instability is characterized by a high tumor mutational burden and responds well to immunotherapy. Mutations in polymerase ɛ, a DNA polymerase involved in DNA replication and repair, are also associated with an ultra-mutated phenotype. We describe a case where a patient with POLE-mutated and hypermutated recurrent colon cancer was treated with pembrolizumab. Treatment with immunotherapy in this patient also led to the clearance of circulating tumor DNA (ctDNA). ctDNA is beginning to emerge as a marker for minimal residual disease in many solid malignancies, including colon cancer. Its clearance with treatment suggests that the selection of pembrolizumab on the basis of identifying a POLE mutation on next-generation sequencing may increase disease-free survival in this patient.

Genetic coding variant in complement factor B (CFB) is associated with increased risk for perianal Crohn's disease and leads to impaired CFB cleavage and phagocytosis.

OBJECTIVE: Perianal Crohn's disease (pCD) occurs in up to 40% of patients with CD and is associated with poor quality of life, limited treatment responses and poorly understood aetiology. We performed a genetic association study comparing CD subjects with and without perianal disease and subsequently performed functional follow-up studies for a pCD associated SNP in Complement Factor B (CFB). DESIGN: Immunochip-based meta-analysis on 4056 pCD and 11 088 patients with CD from three independent cohorts was performed. Serological and clinical variables were analysed by regression analyses. Risk allele of rs4151651 was introduced into human CFB plasmid by site-directed mutagenesis. Binding of recombinant G252 or S252 CFB to C3b and its cleavage was determined in cell-free assays. Macrophage phagocytosis in presence of recombinant CFB or serum from CFB risk, or protective CD or healthy subjects was assessed by flow cytometry. RESULTS: Perianal complications were associated with colonic involvement, OmpC and ASCA serology, and serology quartile sum score. We identified a genetic association for pCD (rs4151651), a non-synonymous SNP (G252S) in CFB, in all three cohorts. Recombinant S252 CFB had reduced binding to C3b, its cleavage was impaired, and complement-driven phagocytosis and cytokine secretion were reduced compared with G252 CFB. Serine 252 generates a de novo glycosylation site in CFB. Serum from homozygous risk patients displayed significantly decreased macrophage phagocytosis compared with non-risk serum. CONCLUSION: pCD-associated rs4151651 in CFB is a loss-of-function mutation that impairs its cleavage, activation of alternative complement pathway, and pathogen phagocytosis thus implicating the alternative complement pathway and CFB in pCD aetiology.

Long-term Outcomes and Factors Predicting Outcome of IPAA When Used Intentionally for Well-Defined Crohn's Disease.

BACKGROUND: Crohn's disease is considered a contraindication for IPAA. In our prior study, when IPAA was used intentionally for well-defined Crohn's disease, we found a high incidence of recurrent disease with a low incidence of pouch failure. OBJECTIVE: This study aimed to replicate these findings in a larger cohort over a longer period. DESIGN: Retrospective review of a prospective IBD registry. SETTINGS: Large IBD referral center. PATIENTS: Patients with preoperative colorectal Crohn's disease requiring surgery were included in the study. INTERVENTION: IPAA. MAIN OUTCOME MEASURES: Long-term Crohn's disease recurrence, pouch failure, and pouch function. RESULTS: Forty-six patients were identified. Crohn's disease was diagnosed on the basis of perianal disease (n = 18; 39%), small-bowel disease (n = 16; 35%), noncaseating granuloma (n = 10; 22%), and discontinuous inflammation (colorectal skip lesions) (n = 11; 24%). After a median follow-up of 93 (7-291) months, 22 patients (48%) developed recurrent Crohn's disease based on afferent limb disease (n = 14; 30%) or pouch fistulizing disease (n = 8; 18%). Only 4 patients (9%) developed pouch failure. No clinical factor was associated with Crohn's disease recurrence. Young age at the time of surgery and short duration of disease before IPAA were associated with pouch fistula recurrence ( p = 0.003 and p = 0.03, respectively). Most patients (86%) reported excellent continence, with no urgency (67%) and median stool frequency of 6 (range, 3-9) per day. LIMITATION: Retrospective nature and relatively small sample size. CONCLUSION: This largest reported series examining the intentional use of IPAA in Crohn's disease showed a high (48%) incidence of postoperative Crohn's disease with a low (9%) incidence of pouch failure. Young age and short disease course before surgery were risk factors for poor outcomes. Highly motivated patients with colorectal Crohn's disease may consider IPAA and avoid a definitive ileostomy. See Video Abstract at http://links.lww.com/DCR/C171 . RESULTADOS A LARGO PLAZO Y FACTORES PREDICTORES DE RESULTADOS DE LA ANASTOMOSIS ILEOANAL CON RESERVORIO CUANDO SE USA INTENCIONALMENTE PARA LA ENFERMEDAD DE CROHN BIEN DEFINIDA: ANTECEDENTES: La enfermedad de Crohn (EC) se considera una contraindicación para la anastomosis ileoanal con reservorio (IPAA). Nuestro estudio previo de IPAA cuando fue usada intencionalmente para EC bien definida mostró una alta incidencia de enfermedad recurrente con una baja incidencia de falla del reservorio.OBJETIVO: Replicar estos hallazgos en una cohorte más grande durante un período más largo.DISEÑO: Revisión retrospectiva de una base de datos prospectiva de enfermedad inflamatoria intestinal.ESCENARIO: Un centro grande de referencia de EII.PACIENTES: EC colorrectal preoperatoria con necesidad de tratamiento quirúrgico.INTERVENCIÓN: Anastomosis ileoanal con reservorio.RESULTADOS PRINCIPALES: Recurrencia de EC a largo plazo, falla del reservorio y función del reservorio.RESULTADOS: Cuarenta y seis pacientes fueron identificados. El diagnóstico de EC se basó en enfermedad perianal (n = 18; 39%), enfermedad del intestino delgado (n = 16; 35%), granuloma no caseificante (n = 10; 22%) e inflamación discontinua (lesiones salteadas colorrectales) (n = 11; 24%). Después de una mediana de seguimiento de 93 (7-291) meses, 22 (48 %) pacientes desarrollaron EC recurrente debido a enfermedad del asa aferente (n = 14; 30%) o enfermedad fistulizante del reservorio (n = 8; 18%). Solo 4 (9%) pacientes desarrollaron falla del reservorio. Ningún factor clínico se asoció con la recurrencia de EC. La edad joven en el momento de la cirugía y la corta duración de la enfermedad antes de IPAA se asociaron con la recurrencia de la fístula del reservorio ( p = 0.003 y p = 0.03, respectivamente). El recuento de plaquetas preoperatorio más alto fue la única característica clínica significativamente asociada con el fracaso del reservorio ( p = 0.02). La mayoría de los pacientes (86%) reportaron una continencia excelente, sin urgencia (67%) y una mediana de frecuencia evacuatoria de 6 (rango, 3-9) por día.LIMITACIONES: Naturaleza retrospectiva y tamaño de muestra relativamente pequeño.CONCLUSIÓN: Esta serie, la más grande reportada que examina el uso intencional de IPAA en la EC mostró una incidencia alta (48Rectal Cancer: Clinical and Molecular Predictors of a Complete Response to Total Neoadjuvant Therapy%) de EC posoperatoria con una incidencia baja (9%) de falla del reservorio. La edad joven y el curso corto de la enfermedad antes de la cirugía fueron factores de riesgo para pobres resultados. Pacientes altamente motivados con EC colorrectal pueden considerar una IPAA y evitar una ileostomía permanente. Consulte Video Resumen en http://links.lww.com/DCR/C171 . (Traducción-Dr. Jorge Silva Velazco ).

Preoperative CT Indices Predict Nonreach Before IPAA.

BACKGROUND: IPAA aims to restore continence to patients after total proctocolectomy. However, some patients have inadequate small-bowel mesenteric length to achieve reconstruction. No preoperative risk stratification tools of native anatomy exist. OBJECTIVE: We report CT-guided measurements of anatomic landmarks to predict nonreach before IPAA. DESIGN: This is a single-institution retrospective analysis of a prospective database. SETTING: This study was conducted at Cedars-Sinai between January 2007 and December 2021. PATIENTS: Patients with IBD undergoing a 2- or 3-stage IPAA with a preoperative abdominal CT using either an enterography protocol or IV contrast sufficient to visualize mesenteric vasculature were included in the study. CT mesenteric indices were assessed, including total length (representing length required for the pouch to reach the anal canal), mesenteric length (inherent length of small-bowel mesentery), and mobilization length (the difference between total length and mesenteric length). MAIN OUTCOME MEASURES: The primary outcome was IPAA nonreach. The secondary outcomes were association of clinical variables and CT mesenteric indices. RESULTS: Six of 59 patients (10%) experienced nonreach. Mobilization length was longer in the nonreach group by 5.8 cm ( p = 0.01), and mesenteric length was shorter by 3.5 cm ( p = 0.04). Mobilization length ≥17 cm provided 100% sensitivity and 69% specificity (OR 1.46, area under the curve 0.84, p = 0.004) for nonreach. Similarly, a mesenteric length <14.6 cm demonstrated 100% sensitivity and 49% specificity for IPAA nonreach (area under the curve 0.75, p = 0.03). LIMITATIONS: The retrospective nature of the study precluded a standardized imaging protocol. External validation will be required because of the small sample size. CONCLUSIONS: CT-based measurements of length, specifically mesenteric and mobilization length, predict nonreach before IPAA. This method is noninvasive, readily available, and may be useful for preoperative patient counseling and operative planning. See Video Abstract at http://links.lww.com/DCR/C140 . LOS NDICES DE TOMOGRAFA COMPUTARIZADA PREOPERATORIA PREDICEN LA AUSENCIA DE ALCANCE ANTES DE LA ANASTOMOSIS DEL RESERVORIO ILEALANAL: ANTECEDENTES:La anastomosis del reservorio ileoanal tiene como objetivo restaurar la continencia en los pacientes después de una proctocolectomía total. Sin embargo, algunos pacientes tienen una longitud mesentérica del intestino delgado inadecuada para lograr la reconstrucción. No existen herramientas de estratificación del riesgo preoperatorio de la anatomía nativa.OBJETIVO:Informamos mediciones guiadas por tomografía computarizada de puntos de referencia anatómicos para predecir la falta de alcance antes de la anastomosis ileoanal con reservorio.DISEÑO:Este es un análisis retrospectivo de una sola institución de una base de datos prospectiva.AJUSTE:Este estudio se realizó en Cedars-Sinai entre Enero de 2007 y Diciembre de 2021.PACIENTES:Pacientes con enfermedad inflamatoria intestinal que se someten a una anastomosis anal con reservorio ileal en 2 o 3 etapas con una tomografía computarizada abdominal preoperatoria utilizando un protocolo de enterografía o contraste intravenoso suficiente para visualizar la vasculatura mesentérica. Se evaluaron los índices mesentéricos de tomografía computarizada, incluida la longitud total (que representa la longitud requerida para que la bolsa alcance el canal anal), la longitud mesentérica (longitud inherente del mesenterio del intestino delgado) y la longitud de movilización (la diferencia entre la longitud total y la longitud mesentérica).PRINCIPALES MEDIDAS DE RESULTADO:El resultado primario fue falta de alcance de la anastomosis del reservorio ileoanal. Los resultados secundarios fueron la asociación de variables clínicas y los índices mesentéricos de tomografía computarizada.RESULTADOS:Seis de 59 (10%) pacientes experimentaron falta de alcance. La longitud de movilización fue mayor en el grupo sin alcance en 5,8 cm ( p = 0,01) y la longitud mesentérica fue menor en 3,5 cm ( p = 0,04). La longitud de movilización ≥17 cm proporcionó una sensibilidad del 100% y una especificidad del 69% (OR 1,46, AUC 0,84, p = 0,004) para la falta de alcance. De manera similar, una longitud mesentérica <14,6 cm demostró una sensibilidad del 100% y una especificidad del 49% para la falta de alcance de la anastomosis del reservorio ileoanal (AUC 0,75, p = 0,03).LIMITACIONES:La naturaleza retrospectiva del estudio impidió un protocolo de imágenes estandarizado. Se requerirá una validación externa debido al pequeño tamaño de la muestra.CONCLUSIONES:Las mediciones de longitud basadas en tomografía computarizada, específicamente la longitud mesentérica y de movilización, predicen la falta de alcance antes de la anastomosis anal con bolsa ileo. Este método no es invasivo, está fácilmente disponible y puede ser útil para el asesoramiento preoperatorio del paciente y la planificación quirúrgica. Consulte el Video Resumen en https://links.lww.com/DCR/C140 . (Traducción-Dr. Yesenia Rojas-Khalil ).

Feasibility of opioid-free surgery for inflammatory bowel disease.

AIM: Patients undergoing colorectal surgery or those with inflammatory bowel disease (IBD) are particularly at risk for opioid-related complications and progression to long-term opioid dependence. The aim of this work is to explore the real-world possibility of perioperative opioid avoidance in colorectal surgery and IBD. METHOD: We conducted a retrospective analysis of patients aggregated from two prospective studies on multimodal postoperative pain control conducted at a single tertiary referral centre. All patients underwent major colorectal surgery with bowel resection. Patients with chronic preoperative opioid use were excluded. Opioid use was measured in oral morphine equivalents (OME) each postoperative day (POD) and cumulatively for the first 72 h. RESULTS: Our cohort of 209 patients included 148 (71%) with IBD and 61 (29%) non-IBD patients. IBD patients required significantly more opioids cumulatively over the first 72 postoperative hours compared with non-IBD patients [median OME 77 mg (interquartile range 33-148 mg) vs. 4 mg (interquartile range 17-82 mg), respectively; p = 0.001]. Five percent of IBD patients achieved opioid-free postoperative pain control during the entire 72 h postoperative period compared with 12% of non-IBD patients. Only 7% of IBD patients avoided opioid use on POD 1 compared with 20% of non-IBD patients (p = 0.02); however the number of IBD patients increased to 16% on POD 2 then 40% on POD 3, closely resembling the non-IBD cohort at 49% (p = 0.22). CONCLUSION: In the era of modern enhanced recovery protocols and minimally invasive techniques, we show that early postoperative opioid avoidance is feasible in a limited number of IBD patients after colorectal surgery.

Efficacy of Anal Sphincter Division During Fistulotomy in Anal Fissure-Associated Fistula.

BACKGROUND: A subset of chronic anal fissures beget focal infection, leading to concomitant fistula. The optimal management of fissure-associated fistula is unknown. OBJECTIVE: This study aimed to characterize healing rates and effects of fistulotomy in fissure-associated fistula. DESIGN: Retrospective study. SETTING: Urban tertiary center. PATIENTS: Adults who underwent fistulotomy for a fistula associated with a chronic anal fissure were included in the study. However, those with Crohn's disease, a history of lateral internal sphincterotomy, and a fistula not amenable to fistulotomy were excluded. INTERVENTIONS: Patients were managed with fistulotomy. Fissures were otherwise managed conservatively with a step-up approach. MAIN OUTCOME MEASURES: The primary end point was healing, defined as resolution of symptoms and both fistula and fissure wounds within 1 year. Subgroup analysis compared those who underwent subcutaneous fistulotomy (group A) with those who underwent fistulotomy involving anal sphincter fibers (group B). RESULTS: Twenty-four of 38 patients (63%) healed with a median overall follow-up of 6.6 months (4.2-14.1). The overall median time to healing was 4.4 months (2.2-6.0). No clinical or pathologic factors predicted healing. In subgroup analysis, overall subcutaneous fistulotomy healing rates were nonstatically lower at 46% (6/13) compared to fistulotomy involving anal sphincter fibers at 72% (18/25; p = 0.16). There was no difference in time to healing (subcutaneous fistulotomy, 6.7 mo [5.2-8.4] vs fistulotomy involving sphincter, 5.1 mo [2.1-7.0]; p = 0.36). LIMITATIONS: The limitations include treatment bias, with increased utilization of chemical sphincter-relaxing agents in those who did not heal. Findings are not applicable to complex fistulas, Crohn's disease, or atypical fissures. CONCLUSIONS: Patients presenting with chronic fissure and associated subcutaneous, intersphincteric, or low transphincteric fistula are successfully managed with fistulotomy. Patients with a subcutaneous fistula tract exhibited nonstatistically significantly lower rates of healing. See Video Abstract at http://links.lww.com/DCR/C145 . EFICACIA DE LA DIVISIN ESFINTRICA DURANTE LA FISTULOTOMA EN CASOS DE FSTULA ASOCIADA A FISURA ANAL: ANTECEDENTES: Ciertos subgrupos de fisuras anales crónicas ocasionan infección localizada, induciendo la aparición de una fístula anal concomitante. Se desconoce el manejo óptimo de la fístula concomitante a una fisura anal.OBJETIVO: Se trata de caracterizar las tasas de curación y el efecto de la fistulotomía en el tratamiento de la fístula concomitante a la fisura anal.DISEÑO: Estudio retrospectivo.EMPLAZAMIENTO: Centro terciario urbano.PACIENTES: Adultos sometidos a fistulotomía por una fístula concomitante a una fisura anal crónica. Se excluyeron la enfermedad de Crohn, el antecedente de una esfinterotomía lateral interna y las fístulas no susceptibles de fistulotomía.INTERVENCIONES: Los pacientes fueron manejados con una fistulotomía clasica. Por lo demás, las fisuras se trataron de forma conservadora con un enfoque médico escalonado.PRINCIPALES MEDIDAS DE RESULTADO: El criterio principal de valoración fué la cura definitiva, determinada como la resolución completa de los síntomas y de las heridas tanto de la fístula como de la fisura en el plazo de un año. El análisis de los subgrupos comparó los que se sometieron a una fistulotomía subcutánea (grupo A) versus una fistulotomía que involucró las fibras del esfínter anal interno (grupo B).RESULTADOS: 24/38 pacientes (63%) curaron con una mediana de seguimiento global de 6,6 meses (4,2-14,1). El tiempo medio general de curación fue de 4,4 meses (2,2-6,0). Ningún factor clínico o patológico predijo la cura. En el análisis de subgrupos, las tasas generales de cura de la fistulotomía subcutánea no fueron estadísticamente más bajas de 46 % (6/13) comparados con la fistulotomía que involucró las fibras del esfínter anal interno en 72 % (18/25; p = 0,16). No hubo diferencia en el tiempo de cicatrización [fistulotomía subcutánea 6,7 meses (5,2-8,4) conparada a la fistulotomía y esfínterotomía parcial interna a 5,1 meses (2,1-7,0); p = 0,36].LIMITACIONES: Sesgo del tratamiento, con mayor utilización de agentes químicos relajantes de la musculatura esfínteriana en aquellos pacientes que no sanaron. No aplicable a fístulas complejas, enfermedad de Crohn o fisuras atípicas.CONCLUSIÓNES: Los pacientes que presentan fisura crónica y fístula subcutánea, inter-esfintérica o trans-esfintérica baja concomitante se manejan con éxito con una fistulotomía. Los pacientes con un trayecto de fístula subcutánea exhibieron tasas de curación más bajas y no estadísticamente significativas. Consulte Video Resumen en http://links.lww.com/DCR/C145 . (Traducción-Dr. Xavier Delgadillo ).

Impact of postoperative telemedicine visit versus in-person visit on patient satisfaction: A randomized clinical trial.

BACKGROUND: Although telemedicine use has increased dramatically during the COVID-19 pandemic and beyond, the impact of telemedicine versus in-person postoperative visits on patient satisfaction has not been studied prospectively. We hypothesized that telemedicine visits would be noninferior to in-person visits in terms of postoperative colorectal surgery patient satisfaction. METHODS: We conducted a randomized trial of consecutive adult patients undergoing transabdominal colorectal surgery from September 2020 to February 2021. Eligible participants were randomized 1:1 to either receive a telemedicine visit (Arm T) or an in-person visit (Arm I) for their first postoperative appointment. Subsequently, participants in Arm T completed a second postoperative visit in person, and participants in Arm I completed a second postoperative visit via telemedicine. All participants completed a patient satisfaction survey electronically within 24 hours after each postoperative visit. The primary endpoint was total patient satisfaction score. Secondary endpoints included patient-reported safety score, length of visit, and willingness of patients to recommend the practice to their peers. Fisher's exact test, χ2 analysis, and Student's t test were used to compare outcomes. RESULTS: A total of 46 patients were analyzed with 23 each in Arm T and Arm I. The mean age of our study cohort was 50.6 (standard deviation 17.7) years and 52% were female. No significant differences were found between groups in terms of baseline characteristics. With respect to our primary endpoint of total satisfaction score, patient satisfaction scores in Arm T were non-inferior to those in Arm I. Similarly, there was no significant difference in satisfaction scores after the second postoperative visit when the visit types were reversed. We did not find any significant differences between groups in terms of our secondary endpoints. CONCLUSION: Postoperative telemedicine visits were a safe and time-efficient option that maintained high patient satisfaction compared with in-person postoperative visits.

The Surgical Management of Ileal Pouch Strictures.

BACKGROUND: Total proctocolectomy with IPAA reconstruction is the surgical approach of choice in ulcerative colitis, indeterminate colitis, familial adenomatous polyposis, and selected patients with Crohn's disease. Pouch stricture is a common complication after IPAA. OBJECTIVE: This study aims to identify surgical management options for pouch stricture and offer a treatment algorithm. DATA SOURCES: A computer-assisted search of the online bibliographic databases MEDLINE and Embase from 1990 to 2021 was performed. STUDY SELECTION: Randomized controlled trials, cohort studies, observational studies, and case reports were considered. INTERVENTIONS: Mechanical dilation, strictureplasty, stapler resection, pouch advancement, bypass, and repeat IPAA were included. MAIN OUTCOMES: Twenty-three articles were considered eligible. Overall incidence of strictures varied from 5% to 38%. Strictures were categorized into 3 areas: pouch inlet (with a reported incidence of 9% to 56%), mid-pouch (with a reported incidence of 2%), and pouch-anal anastomosis (with a reported incidence of 43% to 87%). Pouch-anal strictures were initially managed using bougie or Hegar dilation, with various surgical procedures advocated when initial dilation failed. Mid-pouch strictures are relatively unstudied with scant data. Pouch inlet strictures can be surgically managed by various transabdominal techniques' including resection and reconnection, strictureplasty, or bypass. RESULTS: Pouch-anal strictures should be managed in a step-up strategy as conservative procedures are associated with acceptable success rates. Initial mechanical dilation using bougie or Hegar dilation has a success rate of >80%, although it is likely to require repeat dilations. When these measures fail, transanal surgical approaches using strictureplasty, stapler resection' or pouch advancement should be offered. Transabdominal pouch revision should be offered to patients refractory to a transanal approach. In mid-pouch strictures, the treatment of choice is pouch revision and reanastomosis. Pouch inlet strictures can be managed by resection, strictureplasty, or bypass depending on the location and length of the stricture and surgeon experience. LIMITATIONS: Studies were often small and retrospectively analyzed. There were no randomized controlled trials or comparison between different treatment options.

Circulating tumor DNA dynamics and response to immunotherapy in colorectal cancer.

Circulating tumor DNA (ctDNA) is increasingly being investigated as a tool to detect minimal residual disease in resected, stage I-III colorectal cancer. Recent ctDNA studies have indicated that detection of ctDNA following surgery for resectable colorectal cancer confers a significantly higher risk of recurrence than those with negative ctDNA postoperatively. In those with postoperative ctDNA positivity, clearance of minimal residual disease with adjuvant chemotherapy is a positive prognostic indicator. Lastly, ctDNA has demonstrated superior sensitivity to the conventional blood tumor marker carcinoembryonic antigen (CEA) and can offer median lead times of up to 11 months for radiographic detection of recurrence during the surveillance of resected, stage I-III colorectal cancer. In metastatic colorectal cancer (mCRC), there is growing evidence to suggest that plasma ctDNA can be used to monitor tumor response to conventional chemotherapy as well. The present case series demonstrated that plasma ctDNA is a predictor of tumor response to immunotherapy in patients with mCRC that are microsatellite stable or microsatellite instability high. Plasma ctDNA could serve as a dynamic marker of immunotherapy response even in colorectal tumors that were CEA non-producers. Overall, these findings add to ongoing efforts to establish the role of plasma ctDNA in monitoring response to immunotherapy in CRC.

A Single-Center Comparative Study of Open Transabdominal and Laparoscopic Transanal Ileal Pouch-Anal Anastomosis with Total Mesorectal Excision. Has the Bar Been Raised?

BACKGROUND: Most ulcerative colitis (UC) patients requiring surgery undergo transabdominal ileal pouch-anal anastomosis (IPAA) performed minimally invasively or open. Although one multicenter study demonstrated acceptably low morbidity after transanal pouch, our initial single-center experience with transanal IPAA (ta-IPAA) was associated with an unacceptably high rate of anastomotic leak. The aim of this study was to compare the short-term outcomes of ta-IPAA and transabdominal IPAA with growing experience of transanal proctectomy and determine whether one approach offered any advantage or benefit over the other. METHODS: Single-center series of consecutive ulcerative colitis patients underwent 3-stage IPAA, either ta-IPAA or transabdominal IPAA at a tertiary referral center. The primary outcome measure was overall complications until immediately prior to stoma closure. Secondary outcomes included postoperative clinical measures. RESULTS: The study group consisted of 113 patients, which included 37 (33%) patients undergoing transabdominal or open IPAA and 76 (67%) patients undergoing ta-IPAA. The overall complication rate was numerically higher in the ta-IPAA group (56%) compared to the transabdominal group (38%) (p = 0.07) as was the incidence of anastomotic leak in the ta-IPAA group (12 vs. 5%) (p = 0.17). Mean length of hospital stay was significantly higher in the transanal IPAA group (p = 0.04). Operating time, opioid use and pain scores were similar between groups. CONCLUSION: Transanal IPAA has a higher incidence of overall complications and anastomotic leak compared to transabdominal IPAA. Postoperative length of stay is significantly higher in patients undergoing ta-IPAA. Operating room time, opiate use and pain scores are comparable between the two surgical approaches. Transanal IPAA appears to offer little advantage over transabdominal IPAA.

Magnitude of Preoperative C-Reactive Protein Elevation Is Associated With De Novo Crohn's Disease After Ileal Pouch-Anal Anastomosis in Patients With Severe Colitis.

BACKGROUND: Total proctocolectomy with ileal pouch-anal anastomosis has become the standard procedure for patients with medically refractory ulcerative colitis, although a subset will develop de novo Crohn's disease. OBJECTIVE: In this study, we investigated the association of preoperative C-reactive protein levels with the development of de novo Crohn's disease after ileal pouch-anal anastomosis. DESIGN: A prospectively maintained database of patients undergoing ileal pouch-anal anastomosis was reviewed. PATIENTS: Preoperative C-reactive protein levels were compared between patients who developed de novo Crohn's disease and those who did not. De novo Crohn's disease was defined as small-bowel inflammation proximal to the ileal pouch or perianal disease identified more than 3 months after ileostomy closure. To minimize the heterogeneity of the timing of preoperative C-reactive protein measurement and the severity of ulcerative colitis, only hospitalized patients who had proctocolectomy for severe ulcerative colitis were included in the study. MAIN OUTCOME MEASURES: Development of de novo Crohn's disease was analyzed. RESULTS: Of 105 patients, 23 (22%) developed de novo Crohn's disease. Having C-reactive protein in the third tertile significantly increased the risk of developing de novo Crohn's disease (HR 3.44, 95% CI 1.10- 10.70, p = 0.03) compared to in the first tertile. In a multivariable model, a C-reactive protein in the third or second tertile vs the first tertile and younger age was associated with the development of de novo Crohn's disease. LIMITATIONS: Limited to only hospitalized patients with severe ulcerative colitis. CONCLUSIONS: In hospitalized patients undergoing ileal pouch-anal anastomosis for medically refractory ulcerative colitis, higher preoperative C-reactive protein levels appear to increase the risk of developing de novo Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B750.LA MAGNITUD DE LA ELEVACIÓN PREOPERATORIA DE LA PROTEÍNA C REACTIVA SE ASOCIA CON APARICIÓN DE UNA ENFERMEDAD DE CROHN DE NOVO DESPUÉS DE UNA ANASTOMOSIS DE BOLSA ILEAL AL ANO EN PACIENTES CON COLITIS SEVERAANTECEDENTES:La proctocolectomía total con anastomosis bolsa ileal-anal se ha convertido en el procedimiento estándar para los pacientes con colitis ulcerativa refractaria al tratamiento médico, aunque un subgrupo desarrollará una enfermedad de Crohn de novo.OBJETIVO:En este estudio investigamos la asociación de los niveles de proteína C reactiva preoperatoria con el desarrollo de la enfermedad de Crohn de novo, después de la anastomosis bolsa ileal-anal.DISEÑO:Se revisó una base de datos recolectada en forma prospectiva, de pacientes sometidos a anastomosis bolsa ileal-anal.PACIENTES:Se compararon los niveles de proteína C reactiva preoperatoria entre los pacientes que desarrollaron la enfermedad de Crohn de novo y los que no la desarrollaron. La enfermedad de Crohn de novo se definió como una inflamación del intestino delgado proximal a la bolsa ileal o una enfermedad perianal identificada más de 3 meses después del cierre de la ileostomía. Para minimizar la heterogeneidad del momento de la medición de la proteína C reactiva preoperatoria y la gravedad de la colitis ulcerativa, solo se incluyeron en el estudio los pacientes hospitalizados que se sometieron a una proctocolectomía por colitis ulcerativa grave.PRINCIPALES MEDIDAS DE RESULTADO:se analizó el desarrollo de la enfermedad de Crohn de novo.RESULTADOS:De 105 pacientes, 23 (22%) desarrollaron enfermedad de Crohn de novo. Tener una proteína C reactiva en el tercer tercil aumentó significativamente el riesgo de desarrollar la enfermedad de Crohn de novo (HR 3,44, IC del 95%: 1,10-10,70, p = 0,03) en comparación con el primer tercil. En un modelo multivariable, una proteína C reactiva en el tercer o segundo tercil frente al primer tercil y una edad más joven se asoció con el desarrollo de la enfermedad de Crohn de novo.LIMITACIONES:Limitado solo a pacientes hospitalizados con colitis ulcerativa grave.CONCLUSIONES:En pacientes hospitalizados sometidos a anastomosis bolsa ileal-anal por colitis ulcerativa refractaria al tratamiento médico, niveles más elevados de proteína C reactiva preoperatoria parecen aumentar el riesgo de desarrollar enfermedad de Crohn de novo. Consulte Video Resumen en http://links.lww.com/DCR/B750. (Traducción-Eduardo Londoño-Schimmer).

Is Intestinal Diversion an Effective Treatment for Distal Crohn's Disease?

BACKGROUND: Fecal diversion with an ileostomy is selectively used in cases of medically refractory Crohn's proctocolitis or advanced perianal disease. The aim of this study was to evaluate clinical improvement after fecal diversion in Crohn's disease (CD) and factors associated with clinical improvement. METHODS: A retrospective chart review of adult CD patients undergoing ileostomy formation for distal disease between 2000 and 2019 at 2 CD referral centers was conducted. The primary outcome was the rate of clinical improvement with diversion that allowed for successful restoration of intestinal continuity. Secondary outcomes included the rate of clinical and endoscopic improvement after fecal diversion, ileostomy morbidity, need for subsequent total proctocolectomy and end ileostomy, and factors associated with a clinical response to fecal diversion. RESULTS: A total of 132 patients with a median age of 36 years (interquartile range, 25-49) were included. Mean duration of disease was 16.2 years (10.4) years. Indication for surgery was medically refractory proctocolitis with perianal disease (n = 59; 45%), perianal disease alone (n = 24; 18%), colitis (n = 37; 28%), proctitis (n = 4; 3%), proctocolitis alone (n = 4; 3%), and ileitis with perianal disease (n = 4; 3%). Medications used before surgery included corticosteroids (n = 59; 45%), immunomodulators (n = 55; 42%) and biologics (n = 82; 62%). The clinical and endoscopic response to diversion was 43.2% (n = 57) and 23.9% (n = 16). At a median follow-up of 35.3 months (interquartile range, 10.6-74.5), 25 patients (19%) had improved and had ileostomy reversal, but 86 (65%) did not improve, with 50 (38%) undergoing total proctocolectomy for persistent symptoms. There were no significant predictors of clinical improvement. CONCLUSIONS: The use of a "temporary" ileostomy is largely ineffective in achieving clinical response.