Efficacy and Safety of Intraoperative Hyperthermic Intraperitoneal Chemotherapy for Locally Advanced Colon Cancer: A Phase 3 Randomized Clinical Trial.

Importance: Peritoneal metastasis in patients with locally advanced colon cancer (T4 stage) is estimated to recur at a rate of approximately 25% at 3 years from surgical resection and is associated with poor prognosis. There is controversy regarding the clinical benefit of prophylactic hyperthermic intraperitoneal chemotherapy (HIPEC) in these patients. Objective: To assess the efficacy and safety of intraoperative HIPEC in patients with locally advanced colon cancer. Design, Setting, and Participants: This open-label, phase 3 randomized clinical trial was conducted in 17 Spanish centers from November 15, 2015, to March 9, 2021. Enrolled patients were aged 18 to 75 years with locally advanced primary colon cancer diagnosed preoperatively (cT4N02M0). Interventions: Patients were randomly assigned 1:1 to receive cytoreduction plus HIPEC with mitomycin C (30 mg/m2 over 60 minutes; investigational group) or cytoreduction alone (comparator group), both followed by systemic adjuvant chemotherapy. Randomization of the intention-to-treat population was done via a web-based system, with stratification by treatment center and sex. Main Outcomes and Measures: The primary outcome was 3-year locoregional control (LC) rate, defined as the proportion of patients without peritoneal disease recurrence analyzed by intention to treat. Secondary end points were disease-free survival, overall survival, morbidity, and rate of toxic effects. Results: A total of 184 patients were recruited and randomized (investigational group, n = 89; comparator group, n = 95). The mean (SD) age was 61.5 (9.2) years, and 111 (60.3%) were male. Median duration of follow-up was 36 months (IQR, 27-36 months). Demographic and clinical characteristics were similar between groups. The 3-year LC rate was higher in the investigational group (97.6%) than in the comparator group (87.6%) (log-rank P = .03; hazard ratio [HR], 0.21; 95% CI, 0.05-0.95). No differences were observed in disease-free survival (investigational, 81.2%; comparator, 78.0%; log-rank P = .22; HR, 0.71; 95% CI, 0.41-1.22) or overall survival (investigational, 91.7%; comparator, 92.9%; log-rank P = .68; HR, 0.79; 95% CI, 0.26-2.37). The definitive subgroup with pT4 disease showed a pronounced benefit in 3-year LC rate after investigational treatment (investigational: 98.3%; comparator: 82.1%; log-rank P = .003; HR, 0.09; 95% CI, 0.01-0.70). No differences in morbidity or toxic effects between groups were observed. Conclusions and Relevance: In this randomized clinical trial, the addition of HIPEC to complete surgical resection for locally advanced colon cancer improved the 3-year LC rate compared with surgery alone. This approach should be considered for patients with locally advanced colorectal cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT02614534.

Prevalence of Anxiety and Depression Symptoms and Their Relationship with Nutritional Status and Mortality in Patients with Colorectal Cancer.

BACKGROUND: Anxiety and depression are common in patients with cancer. The aim of this study is to determine the prevalence of anxiety and depression symptoms in colorectal cancer (CRC) patients awaiting elective surgery and whether there is an association with their preoperative nutritional status and postoperative mortality. METHODS: A prospective study was conducted on 215 patients with CRC proposed for surgery. Data about nutritional status were collected using the Global Leadership Initiative on Malnutrition (GLIM) criteria, while anxiety and depression symptoms data were collected using Hospital Anxiety and Depression Scale (HADS). RESULTS: HADS detected possible anxiety in 41.9% of patients, probable anxiety in 25.6%, possible depression in 21.9%, and probable depression in 7.9%. GLIM criteria found 116 (53.9%) patients with malnutrition. The HADS score for depression subscale was significantly higher in malnourished patients than in well-nourished (5.61 ± 3.65 vs. 3.95 ± 2.68; p = 0.001). After controlling for potential confounders, malnourished patients were 10.19 times more likely to present probable depression (95% CI 1.13-92.24; p = 0.039). Mortality was 1.9%, 4,2%, and 5.6% during admission and after 6 and 12 months, respectively. Compared to patients without depressive symptomatology, in patients with probable depression, mortality risk was 14.67 times greater (95% CI 1.54-140.21; p = 0.02) during admission and 6.62 times greater (95% CI 1.34-32.61; p = 0.02) after 6 months. CONCLUSIONS: The presence of anxiety and depression symptoms in CRC patients awaiting elective surgery is high. There is an association between depression symptoms, preoperative nutritional status, and postoperative mortality.

Poor Physical Performance Is Associated with Postoperative Complications and Mortality in Preoperative Patients with Colorectal Cancer.

Introduction: Poor physical performance has been shown to be a good predictor of complications in some pathologies. The objective of our study was to evaluate, in patients with colorectal neoplasia prior to surgery, physical performance and its relationship with postoperative complications and in-hospital mortality, at 1 month and at 6 months. Methods: We conducted a prospective study on patients with preoperative colorectal neoplasia, between October 2018 and July 2021. Physical performance was evaluated using the Short Physical Performance Battery (SPPB) test and hand grip strength (HGS). For a decrease in physical performance, SPPB < 10 points or HGS below the EWGSOP2 cut-off points was considered. Nutritional status was evaluated using subjective global assessment (SGA). The prevalence of postoperative complications and mortality during admission, at 1 month, and at 6 months was evaluated. Results: A total of 296 patients, mean age 60.4 ± 12.8 years, 59.3% male, were evaluated. The mean BMI was 27.6 ± 5.1 kg/m2. The mean total SPPB score was 10.57 ± 2.07 points. A total of 69 patients presented a low SPPB score (23.3%). Hand grip strength showed a mean value of 33.1 ± 8.5 kg/m2 for men and 20.7 ± 4.3 kg/m2 for women. A total of 58 patients presented low HGS (19.6%). SGA found 40.2% (119) of patients with normal nourishment, 32.4% (96) with moderate malnutrition, and 27.4% (81) with severe malnutrition. Postoperative complications were more frequent in patients with a low SPPB score (60.3% vs. 38.6%; p = 0.002) and low HGS (64.9% vs. 39.3%, p = 0.001). A low SPPB test score (OR 2.57, 95% CI 1.37−4.79, p = 0.003) and low HGS (OR 2.69, 95% CI 1.37−5.29, p = 0.004) were associated with a higher risk of postoperative complications after adjusting for tumor stage and age. Patients with a low SPPB score presented an increase in in-hospital mortality (8.7% vs. 0.9%; p = 0.021), at 1 month (8.7% vs. 1.3%; p = 0.002) and at 6 months (13.1% vs. 2.2%, p < 0.001). Patients with low HGS presented an increase in mortality at 6 months (10.5% vs. 3.3%; p = 0.022). Conclusions: The decrease in physical performance, evaluated by the SPPB test or hand grip strength, was elevated in patients with colorectal cancer prior to surgery and was related to an increase in postoperative complications and mortality.

Fistulización a recto de un teratoma quístico maduro, una rara complicación / Rectal fistulization of a mature cystic teratoma, a rare complication

RESUMEN Los teratomas quísticos maduros son los tumores ováricos más frecuentes. La fistulización de estos a órganos vecinos (colon, intestino delgado y vejiga) es una complicación que cuando se presenta nos obliga a descartar un proceso infiltrativo. Tanto la malignización como la formación de fistulas son complicaciones excepcionales. Está descrito en la bibliografía la malignización como mecanismo de formación de dichas fistulas. Este hecho nos suele obligar a llevar a cabo intervenciones agresivas, como exenteraciones pélvicas anteriores y posteriores. Sin embargo, una revisión de los casos publicados (18) muestra que sólo el 22 % de las fistulas son resultado de una malignización de dicho teratoma. Presentamos una paciente con un teratoma quístico maduro que fistulizó a recto y su manejo en nuestro servicio. Precis: La fistulización a órganos vecinos de un teratoma es una complicación excepcional que requiere un diagnóstico preciso puesto que no siempre es secundaria a neoplasia.

ABSTRACT Mature cystic teratomas are the most common ovarian tumors. The fistulization of these teratomas to adjacent organs (colon, small intestine and bladder) is a complication that when it occurs forces us to rule out an infiltrative process. Together with malignancy, the fistula is a rare complication. Literature describes malignancy as a mechanism for the formation of these fistulas. This event usually forces us to carry out aggressive interventions, such as anterior and posterior pelvic exenterations. However, the case records of 18 patients report that only 22 % of fistulas are produced by malignant teratoma. The following case study presents a mature cystic teratoma that fistulated the rectum and its management in our service.

Are there intra-operative hemodynamic differences between the Coliseum and closed HIPEC techniques in the treatment of peritoneal metastasis? A retrospective cohort study.

BACKGROUND: Although two main methods of intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC) are currently accepted, the superiority of one over the other has not yet been demonstrated. The purpose of this study was to determine whether there are hemodynamic and temperature differences between patients who received HIPEC in two different techniques, open versus closed abdomen. METHODS: This retrospective study was conducted in our center between 2011-2015 in 30 patients who underwent surgery for peritoneal carcinomatosis secondary to colorectal cancer, in whom cytoreduction and HIPEC were performed by the Coliseum (15) or closed techniques (15). The main end points were morbidity, mortality, hemodynamic changes, and abdominal temperature. The comparative analysis of quantitative variables at different times was done with the parametric repeated measure ANOVA for those variables that fulfilled the suppositions of normality and independence and the Friedman non-parametric test for the variables that did not fulfill either of these suppositions. RESULTS: There were no deaths in either group. The incidence of postoperative complications in the Coliseum group was 53% (8 patients), grade II-III. The incidence of complications in the closed group was 13% (2 patients), grade II-III. The intra-operative conditions regarding the systolic and diastolic pressures were more stable using the closed abdomen technique (but not significantly so). We found statistically significant differences in abdominal temperature in favor of the closed technique (p = 0.009). CONCLUSIONS: Both HIPEC procedures are similar. In our series, the closed technique resulted in a more stable intra-abdominal temperature.

Linfangioma quístico esplénico / Splenic cystic lymphangioma

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Uso endoscópico de electrocauterio en el tratamiento de estenosis anastomótica ileorrectal / Endoscopic treatment with diathermy of ileorectal anastomotic stricture

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Tratamiento agresivo de las complicaciones arteriales del trasplante hepático. Impacto sobre la supervivencia y las complicaciones biliares / Aggressive management of the arterial complications of liver transplantation. Impact upon survival and biliary complications

Se estudian las complicaciones arteriales (CA) ocurridas en 400 trasplantes realizados entre 1997 y 2006. Se dividen en 2 grupos según el tipo de tratamiento realizado: grupo i: tratamiento invasivo (tratamiento sobre la arteria o retrasplante), y grupo ii: tratamiento conservador o sintomático. Se analizan el impacto del tratamiento sobre la supervivencia y las complicaciones biliares (CB).Resultados Se han presentado 18 CA (4,5%), 10 complicaciones precoces (7 trombosis y 3 estenosis) y 8 complicaciones tardías (5 trombosis y 3 estenosis). El 90% de las complicaciones precoces se trató de forma invasiva (4 trombectomías urgentes, un retrasplante, 3 angioplastias y una ligadura de arteria hepática), y el 25% de las complicaciones tardías se trató con retrasplante (3); el 75% restante recibió tratamiento sintomático. Resultados La supervivencia a 12 y 60 meses fue inferior en el grupo ii (el 57 y el 42%) que en el grupo i (el 90 y el 68%), aunque sin alcanzar significación estadística. La tasa global de CB de enfermos con trombosis arterial fue del 50%. En el grupo i del %, significativamente menor que el grupo ii con el 71% (p<0,04).Conclusiones El tratamiento invasivo de las CA en el trasplante hepático se asocia a una mayor supervivencia a corto plazo y reduce de forma significativa la aparición de CB. En nuestra experiencia, los pacientes se benefician de un diagnóstico precoz y un tratamiento intensivo en este tipo de complicaciones (AU)

Abstract A study was made of the arterial complications documented in 400 transplants performed between 1997 and 2006. The patients were divided into two groups according to the type of treatment provided. Group I: invasive management (arterial treatment or re-transplant), and Group II: conservative or symptomatic management. The impact of management upon survival and biliary complications was analysed. Results There were 18 arterial complications (4.5%): 10 early (7 thromboses and 3 stenoses) and 8 late (5 thromboses and 3 stenoses). Ninety percent of the early complications were subjected to invasive management (4 emergency thrombectomies, 1 re-transplant and 3 angioplasties), while 25% of the late complications were treated in the form of re-transplant and the remaining 75% were subjected to symptomatic treatment. Survival after 12 and 60 months was lower in Group II (57% and 42%) than in Group I (90% and 68%), although without reaching statistical significance. The overall biliary complications rate among the patients with arterial thrombosis was 50%. The rate was significantly lower in Group I than in Group II (10% versus 71%) (P<04).Conclusions Invasive management of the arterial complications of liver transplantation is associated with longer short-term survival and significantly fewer biliary complications. In our experience, patients benefit from an early diagnosis and aggressive management of complications of this kind (AU)

[Aggressive management of the arterial complications of liver transplantation. Impact upon survival and biliary complications]. / Tratamiento agresivo de las complicaciones arteriales del trasplante hepático. Impacto sobre la supervivencia y las complicaciones biliares.

UNLABELLED: A study was made of the arterial complications documented in 400 transplants performed between 1997 and 2006. The patients were divided into two groups according to the type of treatment provided. Group I: invasive management (arterial treatment or re-transplant), and Group II: conservative or symptomatic management. The impact of management upon survival and biliary complications was analysed. RESULTS: There were 18 arterial complications (4.5%): 10 early (7 thromboses and 3 stenoses) and 8 late (5 thromboses and 3 stenoses). Ninety percent of the early complications were subjected to invasive management (4 emergency thrombectomies, 1 re-transplant and 3 angioplasties), while 25% of the late complications were treated in the form of re-transplant and the remaining 75% were subjected to symptomatic treatment. Survival after 12 and 60 months was lower in Group II (57% and 42%) than in Group I (90% and 68%), although without reaching statistical significance. The overall biliary complications rate among the patients with arterial thrombosis was 50%. The rate was significantly lower in Group I than in Group II (10% versus 71%) (P<04). CONCLUSIONS: Invasive management of the arterial complications of liver transplantation is associated with longer short-term survival and significantly fewer biliary complications. In our experience, patients benefit from an early diagnosis and aggressive management of complications of this kind.

Uso de terapia con presión negativa en heridas con fístulas entéricas / Negative pressure therapy in wounds with enteric fistulas

Objetivos La terapia con presión negativa (VAC, vacuum assisted closure) es una modalidad poco utilizada aún en nuestro país. Consiste en un sistema de aspiración sobre la herida por medio de una esponja y unos adhesivos plásticos. Permite el tratamiento de heridas complejas incluidas aquellas con fístulas intestinales, aunque este punto es controvertido. Presentamos 3 casos de tratamiento con VAC en esta situación y un resumen de los estudios publicados. Pacientes y método Desde la introducción de la terapia VAC en nuestro centro, hemos tratado a 10 pacientes, 3 de ellos presentaban una fístula en el lecho de la herida quirúrgica. Describimos los datos clínicos de los pacientes y el tratamiento que se siguió en cada uno de los casos. Resultados En los 3 casos se consiguió una significativa mejoría clínica local de la enfermedad, con control de los síntomas. En uno de los pacientes pudimos realizar una nueva cirugía para cierre de la fístula con buena evolución de la herida. En los otros 2 casos se consiguió una mejor calidad de vida, aunque ambos fallecieron por la complejidad de la situación general. Conclusiones El tratamiento con VAC, aunque controvertido en las fístulas intestinales, puede ayudar a mejorar la situación local de las heridas, el confort de los enfermos y su situación general (AU)

Objective Negative pressure therapy (VAC, vacuum assisted closure) is a method used still in our country. It consists of a system of aspirating a wound by means of a piece of foam and a few adhesive films. It allows the treatment of complex wounds, included (although this is still controversial) those with intestinal fistulas. We present 3 cases of treatment with VAC in this situation and a review of the published literature. Patients and method We have treated 10 patients, since VAC therapy was introduced into our centre of which 3 of whom had a fistula in the bed of the surgical wound. We describe the clinical information of the patients and the therapy that followed in each of the cases. Results Significant local clinical improvement of the disease, with control of the symptoms, was achieved in all 3 cases. We were able to re-operate to close the fistula in one of the patients, with subsequent good progression of the wound. In the other two cases it gave them a better quality of life although both died due to the overall complexity of their situation. Conclusions VAC therapy, although controversial in the treatment of intestinal fistulas, can help to improve the local situation of the wounds, the comfort of the patients and their general situation (AU)

[Negative pressure therapy in wounds with enteric fistulas]. / Uso de terapia con presión negativa en heridas con fístulas entéricas.

OBJECTIVE: Negative pressure therapy (VAC, vacuum assisted closure) is a method used still in our country. It consists of a system of aspirating a wound by means of a piece of foam and a few adhesive films. It allows the treatment of complex wounds, included (although this is still controversial) those with intestinal fistulas. We present 3 cases of treatment with VAC in this situation and a review of the published literature. PATIENTS AND METHOD: We have treated 10 patients, since VAC therapy was introduced into our centre of which 3 of whom had a fistula in the bed of the surgical wound. We describe the clinical information of the patients and the therapy that followed in each of the cases. RESULTS: Significant local clinical improvement of the disease, with control of the symptoms, was achieved in all 3 cases. We were able to re-operate to close the fistula in one of the patients, with subsequent good progression of the wound. In the other two cases it gave them a better quality of life although both died due to the overall complexity of their situation. CONCLUSIONS: VAC therapy, although controversial in the treatment of intestinal fistulas, can help to improve the local situation of the wounds, the comfort of the patients and their general situation.