Hospital Volume for Rectal Cancer Resection Plays a Pivotal Role in Improving Outcomes: A Population-based Analysis.

OBJECTIVE: Assessing the association between hospital surgical volume (SV) and outcomes after rectal cancer surgery (RCS), using national population-based data. SUMMARY BACKGROUND DATA: For RCS, the association of higher SV with improved short- and/or long-term outcomes remains controversial. METHODS: National cancer registry data and administrative data were used to select patients diagnosed with stage I-III rectal cancer in 2009-2018 and who underwent RCS. The average annual SV of RCS was categorised as low (<15; LV), medium (15-29; MV) or high (≥30; HV). The association between SV and 90-day and 1-year excess postoperative mortality (90DPM and 1YEPM) and 5-year observed survival (5YOS) was evaluated. RESULTS: From the 11,519 patients , RCS was performed in LV (4,088; 36%), MV (2,795; 24%) or HV (4,636; 40%) hospitals. Observed 90DPM was significantly better in HV (2.3% 95%CI[1.9,2.8]) than in LV (3.7% 95%CI[3.2,4.4]) and MV (3.5% 95%CI[2.9,4.3]) with adjusted OR 1.4, P<0.0001. Continuous regression analysis showed significantly higher 90DPM in annual SV <35 compared to ≥35 (OR 1.6 95%CI[1.21,2.11]; P=0.0009). Observed 1YEPM was significantly better in HV (2.9% 95%CI[2.2,3.6]) compared to LV (4.7% 95%CI [3.9,5.6]) with adjusted excess HR 1.31 95%CI[1.00,1.73] and P=0.05, and to MV (5.0% 95%CI[4.0,6.1]) with adjusted excess HR 1.45 95%CI[1.09,1.94] and P=0.01. The 5YOS was significantly better in HV (75.9% 95%CI[74.6,77.2]) than in LV (70.3% 95%CI[68.8,71.8]) and MV (71.5% 95%CI[69.7,73.2]) with adjusted HR 1.4 in both LV and MV versus HV, P≤0.003. CONCLUSIONS: This population-based study identified robustly superior outcomes at 90-days, 1-year and 5-years after RCS in hospitals with higher volumes.

Perianal Fistulizing Crohn's Disease: Utilizing the TOpClass Classification in Clinical Practice to Provide Targeted Individualized Care.

BACKGROUND & AIMS: Perianal fistulation is a challenging phenotype of Crohn's disease, with significant impact on quality of life. Historically, fistulae have been classified anatomically in relation to the sphincter complex, and management guidelines have been generalized, with lack of attention to the clinical heterogenicity seen. The recent 'TOpClass classification system' for perianal fistulizing Crohn's disease (PFCD) addresses this issue, and classifies patients into defined groups, which provide a focus for fistula management that aligns with disease characteristics and patient goals. In this article, we discuss the clinical applicability of the TOpClass model and provide direction on its use in clinical practice. METHODS: An international group of perianal clinicians participated in an expert consensus to define how the TOpClass system can be incorporated into real-life practice. This included gastroenterologists, inflammatory bowel disease surgeons, and radiologists specialized in PFCD. The process was informed by the multi-disciplinary team management of 8 high-volume fistula centres in North America, Europe, and Australia. RESULTS: The process produced position statements to accompany the classification system and guide PFCD management. The statements range from the management of patients with quiescent perianal disease to those with severe PFCD requiring diverting-ostomy and/or proctectomy. The optimization of medical therapies, as well as the use of surgery, in fistula closure and symptom management is explored across each classification group. CONCLUSION: This article provides an overview of the system's use in clinical practice. It aims to enable clinicians to have a pragmatic and patient goal-centered approach to medical and surgical management options for individual patients with PFCD.

Short-term outcomes of surgical treatment for primary ileocaecal Crohn's disease: Results of the Crohn's(urg) study, a multicentre, retrospective, comparative analysis between inflammatory and complicated phenotypes.

AIM: Recent evidence challenges the current standard of offering surgery to patients with ileocaecal Crohn's disease (CD) only when they present complications of the disease. The aim of this study was to compare short-term results of patients who underwent primary ileocaecal resection for either inflammatory (luminal disease, earlier in the disease course) or complicated phenotypes, hypothesizing that the latter would be associated with worse postoperative outcomes. METHOD: A retrospective, multicentre comparative analysis was performed including patients operated on for primary ileocaecal CD at 12 referral centres. Patients were divided into two groups according to indication of surgery for inflammatory (ICD) or complicated (CCD) phenotype. Short-term results were compared. RESULTS: A total of 2013 patients were included, with 291 (14.5%) in the ICD group. No differences were found between the groups in time from diagnosis to surgery. CCD patients had higher rates of low body mass index, anaemia (40.9% vs. 27%, p < 0.001) and low albumin (11.3% vs. 2.6%, p < 0.001). CCD patients had longer operations, lower rates of laparoscopic approach (84.3% vs. 93.1%, p = 0.001) and higher conversion rates (9.3% vs. 1.9%, p < 0.001). CCD patients had a longer hospital stay and higher postoperative complication rates (26.1% vs. 21.3%, p = 0.083). Anastomotic leakage and reoperations were also more frequent in this group. More patients in the CCD group required an extended bowel resection (14.1% vs. 8.3%, p: 0.017). In multivariate analysis, CCD was associated with prolonged surgery (OR 3.44, p = 0.001) and the requirement for multiple intraoperative procedures (OR 8.39, p = 0.030). CONCLUSION: Indication for surgery in patients who present with an inflammatory phenotype of CD was associated with better outcomes compared with patients operated on for complications of the disease. There was no difference between groups in time from diagnosis to surgery.

Quality indicators for ambulatory colectomy: literature search and expert consensus.

BACKGROUND: Care for patients undergoing elective colectomy has become increasingly standardized using Enhanced Recovery Programs (ERP). ERP, encorporating minimally invasive surgery (MIS), decreased postoperative morbidity and length of stay (LOS). However, disruptive changes are needed to safely introduce colectomy in an ambulatory or same-day discharge (SDD) setting. Few research groups showed the feasibility of ambulatory colectomy. So far, no minimum standards for the quality of care of this procedure have been defined. This study aims to identify quality indicators (QIs) that assess the quality of care for ambulatory colectomy. METHODS: A literature search was performed to identify recommendations for ambulatory colectomy. Based on that search, a set of QIs was identified and categorized into seven domains: preparation of the patient (pre-admission), anesthesia, surgery, in-hospital monitoring, home monitoring, feasibility, and clinical outcomes. This list was presented to a panel of international experts (surgeons and anesthesiologists) in a 1 round Delphi to assess the relevance of the proposed indicators. RESULTS: Based on the literature search (2010-2021), 3841 results were screened on title and abstract for relevant information. Nine papers were withheld to identify the first set of QIs (n = 155). After excluding duplicates and outdated QIs, this longlist was narrowed down to 88 indicators. Afterward, consensus was reached in a 1 round Delphi on a final list of 32 QIs, aiming to be a comprehensive set to evaluate the quality of ambulatory colectomy care. CONCLUSION: We propose a list of 32 QI to guide and evaluate the implementation of ambulatory colectomy.

Increased Proportion of Colorectal Cancer in Patients With Ulcerative Colitis Undergoing Surgery in the Netherlands.

INTRODUCTION: The aim of the current study was to assess whether there is an indication shift for surgery in patients with ulcerative colitis (UC) from refractory disease to malignant degeneration over the past 3 decades. METHODS: All patients with histologically confirmed UC who underwent a colorectal resection between 1991 and 2020 were extracted from the nationwide Dutch Pathology Registry. The primary outcome was the proportion of colorectal cancer (CRC) in the colon specimens. Outcomes were compared between 3 periods (P1: 1991-2000, P2: 2001-2010, and P3: 2011-2020). RESULTS: Overall, 6,094 patients with UC were included of which 4,854 underwent a (procto)colectomy and 1,240 a segmental resection. In 1,031 (16.9%) patients, CRC was demonstrated in the pathological resection specimen after a median disease duration of 11 years (IQR 3.0-19.0). The proportion of CRC increased from 11.3% in P1, to 16.1% in P2, and 22.8% in P3 ( P < 0.001). Median disease duration at the time of resection increased from 4 years in P1, to 10 years in P2, and 17 years in P3 ( P < 0.001). The proportion of patients diagnosed with advanced malignancy (pT3/T4) (P1: 61.2% vs P2: 65.2% vs P3: 62.4%, respectively, P = 0.633) and lymph node metastasis (N+) (P1: 33.0% vs P2: 41.9% vs P3: 38.2%, respectively, P = 0.113) did not change over time. DISCUSSION: This nationwide pathology study demonstrated an increased proportion of surgery for CRC over the past 3 decades. We hypothesize that the expanding therapeutic armamentarium for UC leads to exhausting medical options and hence postponed colectomy. This, however, might be at the expense of an increased risk of CRC in the long term.

Laparoscopic Oblique Rectus Abdominis Myocutaneous Flap Harvest for Perineal Reconstruction After Abdominoperineal Resection.

BACKGROUND: Treatment of perineal defects after abdominoperineal resection or salvage surgery for either locally advanced rectal cancer or anal carcinoma can be challenging. Myocutaneous flap reconstruction has proven to reduce perineal morbidity and abscess formation in the pelvis; however, it is associated with significant donor-site morbidity. To our knowledge, this is the first report of a laparoscopic oblique rectus abdominis myocutaneous flap harvesting for perineal reconstruction. This technical note aimed to demonstrate the feasibility of the technique. IMPACT OF INNOVATION: Introduction of a laparoscopic technique in harvesting of this flap can potentially further reduce morbidity associated with this flap creation by minimizing abdominal wall trauma and obviating the need for laparotomy for tunneling of the flap intra-abdominally. TECHNOLOGY, MATERIALS, AND METHODS: This report describes a technique using a 6-port laparoscopy, in which the harvesting of the myocutaneous flap was performed after a standardized abdominoperineal resection. The flap itself is passed through the rectus sheath toward the pelvis with the help of a retractor. PRELIMINARY RESULTS: Two patients successfully underwent a laparoscopic oblique rectus abdominis flap reconstruction after abdominoperineal resection. CONCLUSION AND FUTURE DIRECTIONS: This report describes our initial experience with laparoscopic harvesting of an oblique rectus abdominis flap for perineal reconstruction after abdominoperineal resection. We believe the technique is easy and reproducible for laparoscopic surgeons and can reduce donor-site morbidity. However, further studies will be needed to confirm this observation.

Postoperative Complications Are Associated With an Early and Increased Rate of Disease Recurrence After Surgery for Crohn's Disease.

BACKGROUND: Several potential risk factors for Crohn's disease recurrence after surgery have been identified, including age at diagnosis, disease phenotype, and smoking. Despite the clinical relevance, few studies investigated the role of postoperative complications as a possible risk factor for disease recurrence. OBJECTIVE: To investigate the association between postoperative complications and recurrence in Crohn's disease patients after primary ileocolic resection. DESIGN: This was a retrospective case-control study. SETTING: This study was conducted at 2 tertiary academic centers. PATIENTS: We included 262 patients undergoing primary ileocolic resection for Crohn's disease between January 2008 and December 2018 and allocated the patients into recurrent (145) and nonrecurrent (117) groups according to endoscopic findings. MAIN OUTCOME MEASURES: Postoperative complications were assessed as possible risk factors for endoscopic recurrence after surgery by univariable and multivariable analyses. The effect of postoperative complications on endoscopic and clinical recurrence was evaluated by Kaplan-Meier and Cox regression analyses. RESULTS: On binary logistic regression analysis, smoking (OR = 1.84; 95% CI, 1.02-3.32; p = 0.04), penetrating phenotype (OR = 3.14; 95% CI, 1.58-6.22; p < 0.01), perianal disease (OR = 4.03; 95% CI, 1.75-9.25; p = 0.001), and postoperative complications (OR = 2.23; 95% CI, 1.19-4.17; p = 0.01) were found to be independent risk factors for endoscopic recurrence. Postoperative complications (HR = 1.45; 95% CI, 1.02-2.05; p = 0.03) and penetrating disease (HR = 1.73; 95% CI, 1.24-2.40; p = 0.001) significantly reduced the time to endoscopic recurrence; postoperative complications (HR = 1.6; 95% CI, 1.02-2.88; p = 0.04) and penetrating disease (HR = 207.10; 95% CI, 88.41-542.370; p < 0.0001) significantly shortened the time to clinical recurrence. LIMITATIONS: This study was limited by its retrospective design. CONCLUSIONS: Postoperative complications are independent risk factors for endoscopic recurrence after primary surgery for Crohn's disease, affecting the rate and timing of endoscopic and clinical disease recurrence. See Video Abstract at http://links.lww.com/DCR/C48 . LAS COMPLICACIONES POSOPERATORIAS ESTN ASOCIADAS CON UNA TASA TEMPRANA Y AUMENTADA DE RECURRENCIA DE LA ENFERMEDAD DESPUS DE LA CIRUGA PARA LA ENFERMEDAD DE CROHN: ANTECEDENTES: Se han identificado varios factores de riesgo potenciales para la recurrencia de la enfermedad de Crohn después de la cirugía, incluida la edad en el momento del diagnóstico, el fenotipo de la enfermedad y el tabaquismo. A pesar de la relevancia clínica, pocos estudios investigaron el papel de las complicaciones postoperatorias como posible factor de riesgo para la recurrencia de la enfermedad.OBJETIVO: Investigar la asociación entre las complicaciones postoperatorias y la recurrencia en pacientes con enfermedad de Crohn después de la resección ileocólica primaria.DISEÑO: Este fue un estudio retrospectivo de casos y controles.AJUSTE: Este estudio se realizó en dos centros académicos terciarios.PACIENTES: Incluimos 262 pacientes sometidos a resección ileocólica primaria por enfermedad de Crohn entre Enero de 2008 y Diciembre de 2018 y los asignamos en grupos recurrentes (145) y no recurrentes (117) según los hallazgos endoscópicos.PRINCIPALES MEDIDAS DE RESULTADO: Las complicaciones posoperatorias se evaluaron como posibles factores de riesgo de recurrencia endoscópica después de la cirugía mediante análisis univariable y multivariable. El efecto de las complicaciones posoperatorias sobre la recurrencia endoscópica y clínica se evaluó mediante análisis de regresión de Kaplan-Meier y Cox.RESULTADOS: En el análisis, tabaquismo (OR = 1,84; IC 95%: 1,02-3,32; p = 0,04), fenotipo penetrante (OR = 3,14; IC 95%: 1,58-6,22; p < 0,01), enfermedad perianal (OR = 4,03; IC 95%: 1,75-9,25; p = 0,001) y las complicaciones postoperatorias (OR = 2,23; IC 95%: 1,19-4,17; p = 0,01) fueron factores de riesgo independientes para la recurrencia endoscópica. Las complicaciones posoperatorias (HR = 1,45; IC 95%: 1,02-2,05; p = 0,03) y la enfermedad penetrante (HR = 1,73; IC 95%: 1,24-2,40; p = 0,001) redujeron significativamente el tiempo hasta la recurrencia endoscópica; las complicaciones posoperatorias (HR= 1,6; IC 95%: 1,02-2,88; p = 0,04) y la enfermedad penetrante (HR = 207,10; IC 95%: 88,41-542,37; p < 0,0001) acortaron significativamente el tiempo hasta la recurrencia clínica.LIMITACIONES: Este estudio estuvo limitado por su diseño retrospectivo.CONCLUSIONES: Las complicaciones postoperatorias son factores de riesgo independientes para la recurrencia endoscópica después de la cirugía primaria para la enfermedad de Crohn, lo que afecta la tasa y el momento de la recurrencia endoscópica y clínica de la enfermedad. Consulte el Video Resumen en http://links.lww.com/DCR/C48 . (Traducción-Dr. Yesenia Rojas-Khalil ).

Safety and medium-term outcome of redo laparoscopic sacrocolpopexy: a matched case-control study.

INTRODUCTION AND HYPOTHESIS: In the case of recurrent apical prolapse following laparoscopic sacrocolpopexy (LSCP), one may consider a "redo" procedure. We hypothesized that redo LSCP may carry an increased complication risk and less favorable outcomes when compared with primary procedures. METHODS: This is a single-center, matched case-control (1:4) study, comparing all 39 women who had a redo LSCP and 156 women who had a primary LSCP for symptomatic apical prolapse between 2002 and 2020 with a minimum follow-up of 12 months. Matching was based on proximity to the operation date. The primary outcome was the occurrence of intraoperative and early postoperative complications within 3 months. Secondary outcomes included subjective (Patient Global Impression of Change [PGIC] ≥4) and objective (Pelvic Organ Prolapse Quantification [POP-Q] stage <2) success rates, surgical variables, graft-related complications and reinterventions. RESULTS: There was no difference in the rate of intraoperative and early postoperative complications (redo: 21.1% vs control: 29.8%, OR: 0.63, 95% CI 0.27-1.48). The conversion rate was higher in redo patients (redo: 10.3% vs control: 0.6, OR: 17.71, 95% CI 1.92-163.39). Early postoperative complications were comparable: they were mainly infectious and managed by antibiotics. At a comparable follow-up (redo: 81 months (IQR: 54) vs control: 71.5 months (IQR: 42); p=0.37), there were no differences in graft-related complications (redo: 17.9% vs control: 9.6%, p=0.14) and reinterventions for complications (redo: 12.8% vs control: 5.1%, p=0.14) or prolapse (redo: 15.4% vs control: 8.3%, p=0.18). Subjective (redo: 88.5% vs control: 80.2%, p=0.41) and objective (redo: 31.8% vs control: 24.7%, p=0.50) success rates were also comparable. CONCLUSIONS: In our experience, redo LSCP is as safe and effective as a primary LSCP, but there is a higher risk of conversion.

A Breakthrough Improvement Collaborative Significantly Reduces Hospital Stay After Elective Colectomy for Cancer Across a Healthcare System.

OBJECTIVE: This multicenter study aimed to assess (1) the effect of an improvement collaborative on enhanced recovery after surgery (ERAS) protocol adherence after elective colectomy and (2) the association between adherence and patient outcomes. BACKGROUND: ERAS pathways provide a framework to standardize care processes and improve postoperative outcomes in patients after colon surgery. Despite growing evidence of its effectiveness, adherence to these guidelines remains a challenge. METHODS: This prospective, multicenter collaborative was initiated throughout 11 hospitals in Flanders, Belgium. A structured audit tool was used to study patient outcomes and adherence to 12 ERAS components, defined by the collaborative. Three retrospective audits (based on patient record analysis) were conducted in 2017, 2019, and 2021, respectively. RESULTS: Overall, 740 patients were included (45.4% female; mean±SD age, 71±12 years). The overall adherence increased from 42.8% in 2017 to 58.4% in 2019 and 69.2% in 2021. Compared with low adherence, length of stay was increasingly reduced by 1.3 days for medium [95% confidence interval (95% CI): -2.5; 0.0], 3.6 days for high (95% CI: -4.9; -2.2), and up to 4.4 days for very high adherence (95% CI: -6.1; -2.7). Corresponding odds ratios for postoperative complications were 0.62 (95% CI: 0.33; 1.17), 0.19 (95% CI: 0.09; 0.43), and 0.14 (95% CI: 0.05; 0.39), respectively. No increase in 30-day readmissions was observed. CONCLUSIONS: A peer-constructed improvement collaborative effectively increases adherence to an ERAS protocol in individual hospitals. Across time, length of stay and postoperative complications decreased significantly, and a dose-response relationship was observed.

The Role of Pelvic Floor Muscle Training on Low Anterior Resection Syndrome: A Multicenter Randomized Controlled Trial.

BACKGROUND AND OBJECTIVE: Total mesorectal excision (TME) for rectal cancer (RC) often results in significant bowel symptoms, commonly known as low anterior resection syndrome (LARS). Although pelvic floor muscle training (PFMT) is recommended in noncancer populations for treating bowel symptoms, this has been scarcely investigated in RC patients. The objective was to investigate PFMT effectiveness on LARS in patients after TME for RC. METHODS: A multicenter, single-blind prospective randomized controlled trial comparing PFMT (intervention; n=50) versus no PFMT (control; n=54) 1 month following TME/stoma closure was performed. The primary endpoint was the proportion of participants with an improvement in the LARS category at 4 months. Secondary outcomes were: continuous LARS scores, ColoRectal Functioning Outcome scores, Numeric Rating Scale scores, stool diary items, and Short Form 12 scores; all assessed at 1, 4, 6, and 12 months. RESULTS: The proportion of participants with an improvement in LARS category was statistically higher after PFMT compared with controls at 4 months (38.3% vs 19.6%; P =0.0415) and 6 months (47.8% vs 21.3%; P =0.0091), but no longer at 12 months (40.0% vs 34.9%; P =0.3897). Following secondary outcomes were significantly lower at 4 months: LARS scores (continuous, P =0.0496), ColoRectal Functioning Outcome scores ( P =0.0369) and frequency of bowel movements ( P =0.0277), solid stool leakage (day, P =0.0241; night, P =0.0496) and the number of clusters ( P =0.0369), derived from the stool diary. No significant differences were found for the Numeric Rating Scale/quality of life scores. CONCLUSIONS: PFMT for bowel symptoms after TME resulted in lower proportions and faster recovery of bowel symptoms up to 6 months after surgery/stoma closure, justifying PFMT as an early, first-line treatment option for bowel symptoms after RC.

Follow-up Study to Evaluate the Long-term Safety and Efficacy of Darvadstrocel (Mesenchymal Stem Cell Treatment) in Patients With Perianal Fistulizing Crohn's Disease: ADMIRE-CD Phase 3 Randomized Controlled Trial.

BACKGROUND: Darvadstrocel is an expanded allogeneic adipose-derived mesenchymal stem cell therapy for the treatment of complex perianal fistulas in patients with Crohn's disease. Safety and efficacy outcomes from the clinical trial known as "Adipose derived mesenchymal stem cells for induction of remission in perianal fistulizing Crohn's disease," or ADMIRE-CD (NCT01541579), from up to 52 weeks posttreatment were previously reported. Here, the outcomes from an extended 104-week follow-up are reported. OBJECTIVE: The goal of this study was to assess the long-term safety and efficacy of darvadstrocel at 2 years post-treatment in patients with Crohn's disease and complex perianal fistulas. DESIGN: This was a phase 3 double-blind randomized controlled study (ADMIRE-CD) in patients with perianal fistulizing Crohn's disease. SETTINGS: This study extension was conducted in multiple hospitals across 7 European countries and Israel. PATIENTS: Forty patients entered the extended follow-up period: 25 patients in the darvadstrocel treatment group and 15 in the control group. INTERVENTIONS: Darvadstrocel or saline solution (control group) was administered once, locally, after fistula tract curettage and internal opening closure (with previous seton placement). All patients were permitted to continue ongoing medical treatments for fistulas. MAIN OUTCOME MEASURES: Treatment-emergent serious adverse events were recorded through week 104. Clinical remission, defined as closure of all treated external openings that were draining at baseline despite gentle finger compression, was assessed at week 104. RESULTS: Of 40 patients, 37 completed the extended follow-up. Through week 104, 7 treatment-emergent serious adverse events were reported, of which 4 occurred between weeks 52 and 104. At week 104, clinical remission was reported in 14/25 (56%) patients in the darvadstrocel group and 6/15 (40%) patients in the control group. LIMITATIONS: Limitations include the small number of patients who entered the extended follow-up period, and no imaging examinations were performed at the 104-week time point. CONCLUSIONS: Darvadstrocel was well tolerated and clinical remission after treatment with darvadstrocel may be sustained for up to 104 weeks in patients with perianal fistulizing Crohn's disease. See Video Abstract at http://links.lww.com/DCR/B812.ClinicalTrials.gov No: NCT01541579. ESTUDIO DE SEGUIMIENTO PARA EVALUAR LA SEGURIDAD Y EFICACIA A LARGO PLAZO DE DARVADSTROCEL TRATAMIENTO CON CLULAS MADRE MESENQUIMALES EN PACIENTES CON ENFERMEDAD DE CROHN PERIANAL FISTULIZANTE ENSAYO CONTROLADO ALEATORIZADO DE FASE ADMIRECD: ANTECEDENTES:Darvadstrocel es una terapia con células madre mesenquimales alogénicas expandidas derivadas de tejido adiposo para el tratamiento de fístulas perianales complejas en pacientes con enfermedad de Crohn. Los resultados del ensayo clínico conocido como "Células madre mesenquimales derivadas de tejido adiposo para la inducción de la remisión en la enfermedad de Crohn fistulizante perianal" o ADMIRE-CD (NCT01541579), en cuanto a la seguridad y eficacia hasta 52 semanas después del tratamiento, fueron previamente informados. Seguidamente, se presentan los resultados de un seguimiento extendido de 104 semanas.OBJETIVO:Evaluar la seguridad y eficacia a largo plazo de darvadstrocel a dos años del tratamiento en pacientes con enfermedad de Crohn y fístulas perianales complejas.DISEÑO:Este fue un estudio de fase 3, aleatorizado, a doble ciego, controlado (ADMIRE-CD) en pacientes con enfermedad de Crohn perianal fistulizante.DESARROLLO:Esta extensión del estudio se realizó en varios hospitales de siete países europeos e Israel.PACIENTES:Cuarenta pacientes participaron en la extensión de seguimiento: tratamiento con darvadstrocel (n = 25); grupo control (n = 15).INTERVENCIONES:Se administró Darvadstrocel o solución salina (grupo control) una vez, localmente, tras el legrado del trayecto fístuloso y cierre del orificio interno (con la colocación previa de setón). A todos los pacientes se les permitió continuar con los tratamientos médicos en curso para las fístulas.PRINCIPALES MEDIDAS DE RESULTADO:Los eventos de efectos adversos graves derivados del tratamiento se registraron hasta la semana 104. La remisión clínica, definida como el cierre de todas las aberturas externas tratadas que drenaban al inicio espontáneamente o por compresión suave de los dedos, fue evaluado en la semana 104.RESULTADOS:Del total de 40 pacientes, 37 completaron la extensión de seguimiento. Hasta la semana 104, se reportaron 7 eventos de efectos adversos graves resultantes del tratamiento, de los cuales 4 ocurrieron entre las semanas 52 y 104. En la semana 104, se reportó remisión clínica en 14/25 (56%) pacientes en el grupo de darvadstrocel y 6/15 (40%) pacientes en el grupo de control.LIMITACIONES:Solo una pequeña cantidad de pacientes participaron en el período de seguimiento extendido y no se realizaron exámenes por técnicas de imagen en la visita a 104 semanas.CONCLUSIONES:Darvadstrocel fue bien tolerado y la remisión clínica después del tratamiento con darvadstrocel puede mantenerse hasta 104 semanas en pacientes con enfermedad de Crohn perianal fistulizante. Consulte Video Resumen en http://links.lww.com/DCR/B812. (Traducción-Dr Osvaldo Gauto and Dr Julian Panés.)ClinicalTrials.gov No. NCT01541579.

C-reactive protein (CRP) trajectory as a predictor of anastomotic leakage after rectal cancer resection: A multicentre cohort study.

AIM: This study aimed to identify whether CRP-trajectory measurement, including increase in CRP-level of 50 mg/l per day, is an accurate predictor of anastomotic leakage (AL) in patients undergoing resection for rectal cancer. METHODS: A prospective multicentre database was used. CRP was recorded on the first three postoperative days. Sensitivity, specificity, positive and negative predictive values, and area under the receiver operator characteristic (ROC) curve were used to analyse performances of CRP-trajectory measurements between postoperative day (POD) 1-2, 2-3, 1-3 and between any two days. RESULTS: A total of 271 patients were included in the study. AL was observed in 12.5% (34/271). Increase in CRP-level of 50 mg/l between POD 1-2 had a negative predictive value of 0.92, specificity of 0.71 and sensitivity of 0.57. Changes in CRP-levels between POD 2-3 were associated with a negative predictive value, specificity and sensitivity of 0.89, 0.93 and 0.26, respectively. Changes in CRP-levels between POD 1-3 showed a negative predictive value of 0.94, specificity of 0.76 and sensitivity of 0.65. In addition, 50 mg/l changes between any two days showed a negative predictive value of 0.92, specificity of 0.66 and sensitivity of 0.62. The area under the ROC curve for all CRP-trajectory measurements ranged from 0.593-0.700. CONCLUSION: The present study showed that CRP-trajectory between postoperative days lacks predictive value to singularly rule out AL. Early and safe discharge in patients undergoing rectal surgery for adenocarcinoma cannot be guaranteed based on this parameter. High negative predictive values are mainly caused by the relatively low prevalence of AL.

Is evaluation by questionnaires sufficient to cover all aspects of bowel symptoms in rectal cancer patients after low anterior resection?

AIM: The aim of the study was to investigate whether bowel symptoms related to low anterior resection for rectal cancer can be sufficiently well evaluated by the Low Anterior Resection Syndrome (LARS) questionnaire score or the ColoRectal Functional Outcome (COREFO) questionnaire compared with a stool diary. METHOD: All patients underwent low anterior resection for rectal cancer. They were asked to fill out a stool diary, the LARS questionnaire and the COREFO questionnaire, at 1, 4, 6 and 12 months after low anterior resection or stoma closure. The main outcome measure was the amount of association (calculated by means of canonical correlation analysis) between items on anal incontinence for faeces, frequency of bowel movements, clustering of bowel movements, urgency and soiling. RESULTS: Ninety-five patients were included. Items on anal incontinence for faeces and frequency of bowel movements were significantly correlated between the LARS questionnaire or the COREFO questionnaire, versus the stool diary, respectively. Items on soiling were significantly correlated between the COREFO questionnaire and the stool diary. CONCLUSION: Although the LARS questionnaire and the COREFO questionnaire are reliable and valid for measuring low anterior resection syndrome after rectal cancer, our results show that there are no strong associations with the stool diary. Therefore, we can conclude that there is additional clinical information to be obtained from the stool diary. In order to evaluate all aspects of low anterior resection syndrome, we suggest the addition of a stool diary or a combination of different measurement methods during patient follow-up.

Pleural decortication and hyperthermic intrathoracic chemotherapy for pseudomyxoma.

Aim: Pleural dissemination of pseudomyxoma peritonei (PMP) is an extremely rare diagnosis, for which no standard therapy is available.Methods: We describe the successful treatment of a 67-year-old male diagnosed with left-sided intrapleural dissemination of PMP (low-grade appendiceal mucinous neoplasm), 2 years after treatment of abdominal PMP with cytoreductive surgery (CRS) and hyperthermic intra-peritoneal chemotherapy. Treatment consisted of extended pleural decortication (ePD) and oxaliplatin-based hyperthermic intrathoracic chemotherapy (HITHOC). The patient is doing well without complications or signs of recurrence, 26 months after thoracic surgery.Conclusion: ePD in combination with HITHOC is a valuable treatment for thoracic PMP.

Functional outcomes of transanal versus transabdominal restorative proctectomy with ileal pouch-anal anastomosis in ulcerative colitis-a monocentric retrospective comparative study.

BACKGROUND: Ileal pouch-anal anastomosis (IPAA) ensures satisfactory gastro-intestinal function and quality of life (QoL) in patients with refractory ulcerative colitis (UC). The transanal approach to proctectomy and IPAA (Ta-IPAA) has been developed to address the technical shortfalls of the traditional transabdominal approach (Tabd-IPAA). Ta-IPAA has proven to be safe but there is lack of reported functional outcomes. Aim of this study is to compare functional outcomes and QoL after Ta- or Tabd-IPAA for UC. METHODS: This is a retrospective study of consecutive UC patients who underwent IPAA between 2011 and 2017, operated according to a modified 2- or 3-stage approach. Close rectal dissection was performed in Ta-IPAA as opposed to total mesorectal excision in Tabd-IPAA. A propensity score weighting was performed. Functional outcomes were assessed using the pouch functional score (PFS) and the Öresland score (OS). The global quality of life scale (GQOL) was used for patients' perspective on QoL. Follow-up was scheduled at 1, 3, 6, and 12 months, postoperatively. RESULTS: One hundred and eight patients were included: 38 patients had Ta-IPAA. At 12 months follow-up, mean OS and PFS were 4.6 (CI 3.2-6.0) vs 6.2 (CI 5.0-7.3), p = 0.025 and 6.1 (CI 3.5-8.8) vs 7.4 (CI 5.4-9.5), p = 0.32, for Ta and Tabd-IPAA, respectively. Mean GQOL for Ta-IPAA was 82.5 (CI 74.8-90.1) vs 75.5 (69.4-81.7) for Tabd-IPAA (p = 0.045). CONCLUSIONS: At 12 months postoperatively, pouch function and QoL of Ta-IPAA are probably as good as those of Tabd-IPAA. Limitations include retrospectivity, differences in the surgical technique, and lack of validated scores for QoL.

Local Recurrence After Transanal Total Mesorectal Excision for Rectal Cancer: A Multicenter Cohort Study.

OBJECTIVE: This study aimed to determine local recurrence (LR) rate and pattern after transanal total mesorectal excision (TaTME) for rectal cancer. BACKGROUND: TaTME for mid- and low rectal cancer has known a rapid and worldwide adoption. Recently, concerns have been raised on the oncological safety in light of reported high LR rates with a multifocal pattern. METHODS: This was a multicenter observational cohort study in 6 tertiary referral centers. All consecutive TaTME cases for primary rectal adenocarcinoma from the first TaTME case in every center until December 2018 were included for analysis. Patients with benign tumors, malignancies other than adenocarcinoma and recurrent rectal cancer, as well as exenterative procedures, were excluded. The primary endpoint was 2-year LR rate. Secondary endpoints included patterns and treatment of LR and histopathological characteristics of the primary surgery. RESULTS: A total of 767 patients were identified and eligible for analysis. Resection margins were involved in 8% and optimal pathological outcome (clear margins, (nearly) complete specimen, no perforation) was achieved in 86% of patients. After a median follow-up of 25.5 months, 24 patients developed LR, with an actuarial cumulative 2-year LR rate of 3% (95% CI 2-5). In none of the patients, a multifocal pattern of LR was observed. Thirteen patients had isolated LR (without systemic disease) and 10/13 could be managed by salvage surgery of whom 8 were disease-free at the end of follow-up. CONCLUSIONS AND RELEVANCE: This study shows good loco regional control after TaTME in selected cases from tertiary referral centers and does not indicate an inherent oncological risk of the surgical technique.

Rates of Postoperative Recurrence of Crohn's Disease and Effects of Immunosuppressive and Biologic Therapies.

BACKGROUND & AIMS: The Rutgeerts' scoring system is used to evaluate patients with Crohn's disease (CD) following ileocolic resection, based on endoscopic findings at the anastomosis and in the neoterminal ileum. We investigated rates of clinical and surgical recurrence of CD after surgery and effect of therapy modification based on post-operative endoscopic findings. METHODS: We collected data from 365 adults with CD (20% with Rutgeerts' score i0, 10% with score i1, 49% with score i2, 12% with score i3, 9% with score i4) who underwent ileocolonoscopy within 12 months of ileocolic resection with anastomosis from 2000 through 2013 at 2 centers in Belgium and France. Patients were followed for 3 y or more after the ileocolonoscopy. Clinical post-operative recurrence (POR) was defined as occurrence of CD symptoms along with biologic, radiologic, and/or endoscopic features of disease activity; modified surgical POR was defined as either an endoscopic or surgical intervention. RESULTS: After a median follow-up time of 88 months, 48% of patients had clinical POR and 26% had modified surgical POR. Rates of survival without clinical POR or a modified surgical POR were lower in patients with Rutgeerts' scores of i2, i3, or i4 compared to patients with scores of i0 or i1 (P < .001 and P = .02). New immunosuppressant or biological therapy was initiated following endoscopy in 129/254 patients (51%) with Rutgeerts' score of i2, i3, or i4 vs 7/111 patients (6%) with scores of i0 or i1 (odds ratio for new therapy, 14.9; 95% CI, 7.1-36.8; P < .001). A modest decrease in risk of clinical POR was observed for patients with Rutgeerts scores of i3 or i4 after initiation of immunosuppressive or biological therapy based on endoscopic findings (Breslow P = .03), but this was not observed for patients with scores of i2 (Breslow P = .46). CONCLUSIONS: Use of immunosuppressants and tumor necrosis factor antagonists to treat patients with an asymptomatic endoscopic post-operative recurrence of CD did not reduce long-term risk of clinical recurrence in patients with Rutgeerts' scores of i2, but it had a small effect in patients with scores of i3 or i4.

High-Dose Vitamin D Does Not Prevent Postoperative Recurrence of Crohn's Disease in a Randomized Placebo-Controlled Trial.

BACKGROUND & AIMS: Vitamin D deficiency is common in Crohn's disease (CD). High-dose vitamin D had anti-inflammatory effects in preclinical studies and trials of patients with CD. We performed a randomized trial to determine whether high-dose vitamin D prevents postoperative recurrence of CD after ileocolonic resection. METHODS: Patients with CD after ileocolonic resection with ileocolonic anastomosis were assigned randomly to groups given weekly 25,000 IU oral vitamin D (n = 72) or placebo (n = 71) for 26 weeks, at 17 hospitals in The Netherlands and Belgium, from February 2014 through June 2017. Patients were assessed at baseline and at weeks 2, 6, 12, and 26 for laboratory and clinical parameters, and underwent ileocolonoscopy at 26 weeks. The primary end point was endoscopic recurrence (modified Rutgeerts score, ≥i2b, as assessed by blinded readers) at 26 weeks. Secondary end points included clinical recurrence (Crohn's disease activity index, ≥220), quality of life (measured by the 36-Item Short Form Health Survey, Inflammatory Bowel Disease Questionnaire, and EuroQol, a 5-dimension questionnaire), and outcomes associated with the baseline serum concentration of vitamin D. RESULTS: In the vitamin D group, serum levels of 25-hydroxy vitamin D increased from a median of 42 nmol/L at baseline to 81 nmol/L at week 26 (P < .00001), whereas levels did not change significantly in the placebo group and remained unchanged at 43 nmol/L. In the intention-to-treat analysis, the proportion of patients with endoscopic recurrence at 26 weeks did not differ significantly between the vitamin D vs the placebo group (58% vs 66%; P = .37). The cumulative rate of clinical recurrence did not differ significantly between the groups (18.1% in the vitamin D group vs 18.3% in the placebo group; P = .91). Quality of life improved slightly over time in both groups, but did not differ significantly between groups (P = .07). There were few adverse events in either group. CONCLUSIONS: High-dose vitamin D, compared with placebo, did not reduce the incidence of postoperative endoscopic or clinical recurrence of CD in patients who underwent ileocolonic resection with ileocolonic anastomosis. ClinicalTrials.gov no: NCT02010762.

Rectal Cancer in Adolescent and Young Adult Patients: Pattern of Clinical Presentation and Case-Matched Comparison of Outcomes.

BACKGROUND: Rectal cancer in adolescents and young adults (age ≤39) is increasing. Early diagnosis is a challenge in this subset of patients. OBJECTIVE: This study aims to analyze the presentation pattern and outcomes of sporadic rectal cancer in adolescents and young adults. DESIGN: This is a retrospective study. SETTING: This study was conducted at 3 European tertiary centers. PATIENTS: Data on adolescents and young adults operated on for sporadic rectal cancer (January 2008 through October 2019) were analyzed. To compare outcomes, adolescents and young adults were matched to a group of patients aged ≥40 operated on during the same period. MAIN OUTCOME MEASURES: The primary outcomes measured were clinical presentation and long-term outcomes. RESULTS: Sporadic rectal cancers occurred in 101 adolescents and young adults (2.4%; mean age, 33.5; range, 18-39); 51.5% were male, and a smoking habit was reported by 17.8% of patients. The rate of a family history for colorectal cancer was 25.7%, and of these patients, 24.7% were obese. Diagnosis based on symptoms was reported in 92.1% patients, and the mean time from first symptoms to diagnosis was 13.7 months. The most common symptom at diagnosis was rectal bleeding (68.8%), and 12% and 34% of the adolescents and young adults presented with locally advanced or metastatic disease at diagnosis. Consequently, 68.3% and 62.4% adolescents and young adults received neoadjuvant and adjuvant treatments. The rate of complete pathological response was 24.1%; whereas 38.6% patients had stage IV disease, and 93.1% were microsatellite stable. At a mean follow-up of 5 years, no difference in cancer-specific survival, but a lower disease-free survival was reported in adolescents and young adults (p < 0.0001) vs the matched group. Adolescents and young adults with stages I to II disease had shorter cancer-specific survival and disease-free survival (p = 0.006; p < 0.0001); with stage III disease, they had a shorter disease-free survival (p = 0.01). LIMITATIONS: This study was limited by its observational, retrospective design. CONCLUSIONS: The significantly delayed diagnosis in adolescents and young adults may have contributed to the advanced disease at presentation and lower disease-free survival, even at earlier stages, suggesting a higher metastatic potential than in older patients. See Video Abstract at http://links.lww.com/DCR/B537. CNCER DE RECTO EN PACIENTES ADOLESCENTES Y ADULTOS JVENES CUADRO DE PRESENTACIN CLNICA Y COMPARACIN DE DESENLACES POR CASOS EMPAREJADOS: ANTECEDENTES:El cáncer de recto en adolescentes y adultos jóvenes (edad ≤ 39) está aumentando. El diagnóstico temprano es un desafío en este subgrupo de pacientes.OBJETIVO:Analizar el cuadro de presentación y los desenlaces en adolescentes y adultos jóvenes con cáncer de recto esporádico.DISEÑO:Estudio retrospectivo.ÁMBITO:Tres centros europeos de tercer nivel.PACIENTES:Se analizaron los datos de adolescentes y adultos jóvenes operados de cáncer de recto esporádico (enero de 2008 - octubre de 2019). Para comparar los desenlaces se emparejó a adolescentes y adultos jóvenes con un grupo de pacientes mayores de 40 años operados en el mismo período de tiempo.PRINCIPALES VARIABLES ANALIZADAS:Cuadro clínico, resultados a largo plazo.RESULTADOS:Los cánceres de recto esporádicos en adolescentes y adultos jóvenes fueron 101 (2,4%, edad media: 33,5, rango 18-39). El 51,5% eran hombres, el 17,8% de los pacientes fumaba. El 25,7% tentía antecedentes familiares de cáncer colorrectal. El 24,7% eran obesos. El diagnóstico con base en los síntomas se informó en el 92,1% de los pacientes, el tiempo promedio desde los primeros síntomas hasta el diagnóstico fue de 13,7 meses. El síntoma más común en el momento del diagnóstico fue el sangrado rectal (68,8%). 12% y 34% de adolescentes y adultos jóvenes presentaron enfermedad localmente avanzada o metastásica en el momento del diagnóstico. Por lo tanto, el 68,3% y el 62,4% de adolescentes y adultos jóvenes recibieron neoadyuvancia y adyuvancia. La tasa de respuesta patológica completa fue del 24,1%; mientras que el 38,6% estaban en estadio IV. El 93,1% eran microsatelite estable. Con una media de seguimiento de 5 años, no se observaron diferencias en la sobrevida específica del cáncer, pero se informó una menor sobrevida libre de enfermedad en adolescentes y adultos jóvenes (p <0,0001) frente al grupo emparejado. Los adolescentes y adultos jóvenes en estadios I-II tuvieron una sobrevida específica por cáncer y una sobrevida libre de enfermedad más corta (p = 0,006; p <0,0001); el estadio III tuvo una sobrevida libre de enfermedad más baja (p = 0,01).LIMITACIONES:Diseño observacional y retrospectivo.CONCLUSIONES:El diagnóstico notablemente demorado en adolescentes y adultos jóvenes puede contribuir a la presentación de una enfermedad avanzada y a una menor sobrevida libre de enfermedad, incluso en estadios más tempranas, lo cual implica un mayor potencial metastásico en comparación con pacientes mayores. Consulte Video Resumen en http://links.lww.com/DCR/B537.

Functional Outcomes and Quality of Life after Redo Anastomosis in Patients With Rectal Cancer: An International Multicenter Comparative Cohort Study.

BACKGROUND: Redo anastomosis can be considered in selected patients with persistent leakage, stenosis, or local recurrence. It is technically challenging, and little is known about the functional outcomes after this seldomly performed type of surgery. OBJECTIVE: The aim of this study was to compare functional outcomes and the quality of life between redo anastomosis and primary successful anastomosis following total mesorectal excision for rectal cancer. DESIGN: This study was designed as an international multicenter comparative cohort study. SETTINGS: The study was conducted in 3 tertiary referral centers in the Netherlands, Belgium, and France. PATIENTS: Patients undergoing redo anastomosis were compared with patients with a primary successful anastomosis after total mesorectal excision for rectal cancer. MAIN OUTCOME MEASURES: Low anterior resection syndrome score, European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) C30, and EORTC QLQ-CR29 questionnaires were used to assess outcomes. RESULTS: In total, 170 patients were included; 52 underwent redo anastomosis and 118 were controls. Major low anterior resection syndrome occurred in 73% after redo anastomosis compared with 68% following primary successful anastomosis (p = 0.52). The redo group had worse EORTC QLQ-CR29 mean scores for fecal incontinence (p = 0.03) and flatulence (p = 0.008). There were no differences in urinary (p = 0.48) or sexual dysfunction, either in men (p = 0.83) or in women (p = 0.76). Significantly worse scores in the redo group were found for global health (p = 0.002), role (p = 0.049) and social function (p = 0.006), body image (p = 0.03), and anxiety (p = 0.02). LIMITATIONS: This study is limited by the possible response bias. CONCLUSIONS: Redo anastomosis is associated with significantly worse quality of life compared with primary successful anastomosis. However, major low anterior resection syndrome was comparable between groups and should not be a reason to preclude restoration of bowel continuity in highly motivated patients. See Video Abstract at http://links.lww.com/DCR/B565. RESULTADOS FUNCIONALES Y DE CALIDAD DE VIDA POSTERIOR A LA RECONSTRUCCIN DE LA ANASTOMOSIS EN PACIENTES CON CNCER DE RECTO ESTUDIO INTERNACIONAL MULTICNTRICO DE COHORTE COMPARATIVO: ANTECEDENTES:Se puede considerar reconstruir la anastomosis en pacientes seleccionados con fuga persistente, estenosis o recidiva local. Esto es técnicamente desafiante y poco se sabe sobre los resultados funcionales después de este tipo de cirugía que rara vez se realiza.OBJETIVO:El objetivo de este estudio fue comparar resultados funcionales y la calidad de vida entre reconstrucción de la anastomosis y la anastomosis primaria exitosa posterior de la escisión total de mesorrecto (TME) por cáncer de recto.DISEÑO:Este estudio fue diseñado como un estudio internacional multicéntrico de cohorte comparativo.ENTORNO CLINICO:El estudio se llevó a cabo en tres centros de referencia terciarios en Holanda, Bélgica y Francia.PACIENTES:Los pacientes sometidos a reconstrucción de anastomosis fueron comparados con pacientes con anastomosis primaria exitosa después de TME por cáncer de recto.PRINCIPALES MEDIDAS DE VALORACION:Los cuestionarios; Escala de Síndrome de Resección Anterior Baja (LARS), EORTC QLQ-C30, y QLQ-CR29, fueron utilizados para evaluar los resultados.RESULTADOS:En total, se incluyeron 170 pacientes; 52 reconstrucción de anastomosis y 118 controles. LARS ocurrió en el 73% posterior a la reconstrucción de la anastomosis en comparación con el 68% posterior a la anastomosis primaria exitosa (p = 0,52). El grupo de reconstrucción tuvo peores puntuaciones medias de EORTC QLQ-CR29 para incontinencia fecal (p = 0,03) y flatulencia (p = 0,008). No hubo diferencias en disfunción urinaria (p = 0,48) o sexual, ni en hombres (p = 0,83) ni en mujeres (p = 0,76). Se encontraron puntuaciones significativamente peores en el grupo de reconstrucción para salud global (p = 0,002), desempeño (p = 0,049) y función social (p = 0,006), imagen corporal (p = 0,03) y ansiedad (p = 0,02).LIMITACIONES:La limitación de este estudio es el posible sesgo de respuesta.CONCLUSIONES:La reconstrucción de la anastomosis se asocia con una calidad de vida significativamente peor en comparación con los pacientes con anastomosis primaria exitosa. Sin embargo, LARS fue comparable entre los grupos y no debería ser una razón para impedir la restauración de la continuidad intestinal en pacientes muy motivados. Consulte Video Resumen en http://links.lww.com/DCR/B565.