Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection : a double-blind, placebo-controlled, randomised clinical trial

Anti-COVID-19 hyperimmune immunoglobulin (hIG) can provide standardized and controlled antibody content. Data from controlled clinical trials using hIG for the prevention or treatment of COVID-19 outpatients have not been reported. We assessed the safety and efficacy of subcutaneous anti-COVID-19 hyperimmune immunoglobulin 20% (C19-IG20%) compared to placebo in preventing development of symptomatic COVID-19 in asymptomatic individuals with SARS-CoV-2 infection. We did a multicentre, randomized, double-blind, placebo-controlled trial, in asymptomatic unvaccinated adults (≥18 years of age) with confirmed SARS-CoV-2 infection within 5 days between April 28 and December 27, 2021. Participants were randomly assigned (1:1:1) to receive a blinded subcutaneous infusion of 10 mL with 1 g or 2 g of C19-IG20%, or an equivalent volume of saline as placebo. The primary endpoint was the proportion of participants who remained asymptomatic through day 14 after infusion. Secondary endpoints included the proportion of individuals who required oxygen supplementation, any medically attended visit, hospitalisation, or ICU, and viral load reduction and viral clearance in nasopharyngeal swabs. Safety was assessed as the proportion of patients with adverse events. The trial was terminated early due to a lack of potential benefit in the target population in a planned interim analysis conducted in December 2021. registry: . 461 individuals (mean age 39.6 years [SD 12.8]) were randomized and received the intervention within a mean of 3.1 (SD 1.27) days from a positive SARS-CoV-2 test. In the prespecified modified intention-to-treat analysis that included only participants who received a subcutaneous infusion, the primary outcome occurred in 59.9% (91/152) of participants receiving 1 g C19-IG20%, 64.7% (99/153) receiving 2 g, and 63.5% (99/156) receiving placebo (difference in proportions 1 g C19-IG20% vs. placebo, −3.6%; 95% CI -14.6% to 7.3%, p = 0.53; 2 g C19-IG20% vs placebo, 1.1%; −9.6% to 11.9%, p = 0.85). None of the secondary clinical efficacy endpoints or virological endpoints were significantly different between study groups. Adverse event rate was similar between groups, and no severe or life-threatening adverse events related to investigational product infusion were reported. Our findings suggested that administration of subcutaneous human hyperimmune immunoglobulin C19-IG20% to asymptomatic individuals with SARS-CoV-2 infection was safe but did not prevent development of symptomatic COVID-19.

¿Cómo guía la mente al cuerpo? Reganancia de peso dos años después de la cirugía bariátrica, desde un enfoque psico-social.

Introduction: There is no consensus about the cause-effect relationship between psychopathologies and obesity, but it is accepted that the emotional state can interfere with the destructuring of eating patterns and sedentary lifestyle, having an important influence on both body weight. Objective: To analyze the relationship between psychiatric disorders and weight loss failure, two years after bariatric surgery. Material and methods: Cohort, retrospective study. Population: 331 patients who underwent bariatric surgery from 2007 to 2016 at the Hospital de la Santa Creu and Sant Pau. Sample: 331 patients. The data was obtained from the query log. Methods of descriptive and inferential statistics were applied, the factorial ANOVA test of repeated measures was specified, forall cases, a statistical significance p <0.05 was considered. Results: 331 patients were analyzed, of which 95 (28.7%) men and 236 (n = 71.3%) women. The age range ranged from 18 to 65 years. Gastric sleeve is performed in 208 (62.8%) of cases and bypass in 123 (37.2%). The most frequent eating disorder was Glutton (n = 44; 12.4%). The most frequent psychiatric disorder was depression (n = 34; 76.7%). With the student t-test different differences were obtained in the weight loss in the control at the first year and the second year of the surgery (p <0.05). In the repeated measures factorial ANOVA test, a statistically significant relationship between depressive symptoms and weight loss failure was obtained, similarly, between the type of surgery (gastric sleeve) and the weight loss failure. Conclusion: The history of depressive disorders before surgery and the gastric cuff technique is related to the failure in weight loss in these patients.Introducción: No existe un consenso acerca de la relación causa-efecto entre las psicopatologías y la obesidad, pero se acepta que el estado emocional puede interferir en la desestructuración de los patrones alimentarios y en el sedentarismo, teniendo importante influencia ambos en el peso corporal. Objetivo: Analizar la relación que existe entre los trastornos psiquiátricos y la falla en la pérdida de peso, dos años después de la cirugía bariátrica. Material y métodos: Estudio de cohorte, retrospectivo. Población: 331 pacientes a los que se les realizó cirugía bariátrica desde el año 2007 hasta el año 2016 en el Hospital de la Santa Creu y Sant Pau. Muestra: 331 pacientes. Los datos se obtuvieron del registro de consultas. Se aplicaron métodos de estadística descriptivae inferencial, se utilizó el test de ANOVA factorial de medidas repetidas, para todos los casos, se consideró una significación estadística p<0,05. Resultados: se analizaron 331 pacientes, de los cuales 95(28,7%) hombres y 236 (n=71,3%) mujeres. El rango de edad oscilaba entre los 18 y 65 años. Se practicó sleeve gástrico en 208 (62,8%) de los casos y bypass en 123 (37,2%). El trastorno alimentario más frecuente fue el Glotón (n=44; 12,4%). El trastorno psiquiátrico más frecuente fue la depresión (n=34; 76,7%). Con la prueba t de student se obtuvieron diferencias significativas en la pérdida de peso en el control al primer año y al segundo año de la cirugía (p<0,05). En el test de ANOVA factorial de medidas repetidas, se obtuvo una relación estadísticamentesignificativa entre los síntomas depresivos y la falla en la pérdida de peso, de igual manera, entre el tipo de cirugía (Sleeve gástrico) y la falla en la pérdida de peso. Conclusiones: El antecedente de trastornos depresivos antes de la cirugía y la técnica del Sleeve gástrico se relacionaron con la falla en la pérdida de peso en estos pacientes

Single-port splenectomy: Current update and controversies

Multiport laparoscopic splenectomy (LS) is considered the "gold standard" for the management of surgical diseases in normal or slightly enlarged spleens. The concept of minimal-invasive surgical techniques has progressed since the early 1990s from standard multiport laparoscopy to natural orifice transluminal endoscopic surgery (NOTES) and, more recently, to single-port access (SPA). In this paper, we describe our technique for SPA splenectomy and provide a critical review of the current literature on SPA for splenic diseases.Preliminary results published to date indicate that the spleen can be safely removed using single-incision surgery and all the authors have unanimously endorsed the feasibility of this approach. However, available evidence is still scarce. It is based only on case reports and one small series, with a total of 17 patents and, therefore, firm conclusions cannot yet be drawn and more experience and comparative trials are needed to determine the exact role of this interesting new approach. a???5?5

A delayed acute complication of bariatric surgery: Gastric remnant haemorrhagic ulcer after Roux-en-Y gastric bypass

Acute gastric remnant bleeding is an exceptionally rare complication when it occurs long after bariatric surgery. We present the case of a patient with a bleeding ulcer of the excluded stomach (i.e., the remnant), occurring 7 years after Roux-en-Y gastric bypass (RYGB) for morbid obesity. A computed tomography scan managed to locate the active bleeding source in the gastric remnant. During emergency laparotomy, a bleeding ulcer of the fundic region of the excluded stomach was identified. Total resection of the remnant was performed, with good post-operative recovery. To the best of our knowledge, this is the first full report of a significantly delayed haemorrhagic ulcer of the gastric remnant, occurring years after RYGB

Minimally invasive therapy for epiphrenic diverticula: Systematic review of literature and report of six cases

Introduction: Epiphrenic diverticula (ED) are infrequent and conventional surgical treatment entails aggressive open or transthoracic surgery. Minimally invasive treatment has changed the surgical approach but some surgical controversies are not resolved. Objective: The objective of this study is to describe our experience in minimally invasive treatment of the ED and to perform a systematic review of the current literature in this subject. Materials and Methods: We reviewed all data from the Hospital de Sant Pau, focusing on patients that underwent minimally invasive treatment for an ED since 1998 to date. Furthermore, we performed a systematic literature review focused on the minimally invasive approach for ED. Results: A total of 6 patients have been treated (5 transhiatal and 1 with abdominal and thoracic approach). We found a predominance of males with a median age of 63. The diagnosis was made with an endoscopy, barium swallow and manometry. Half of the manometry results were pathologic. The surgical technique involved a diverticulectomy, myotomy and a Dor partial founduplication. Two patients that presented suture line leakage (SLL) were treated conservatively. No mortality was reported. The systematic review was carried out under the Preferred Reporting Items for Systematic Reviews and Meta-analyses scheme, with a total of 20 studies where 189 patients were found. No comparative or prospective randomised trials were found. Overall morbidity was 24%, with a SLL rate of 12%, hospital stay of 5 days and mortality of 1.5%. After a median follow-up of 42 months, 81.5% of the patients were asymptomatic. Conclusion: The minimally invasive approach for ED is a safe and feasible procedure

Single-port splenectomy: Current update and controversies

Multiport laparoscopic splenectomy (LS) is considered the “gold standard” for the management of surgical diseases in normal or slightly enlarged spleens. The concept of minimal-invasive surgical techniques has progressed since the early 1990s from standard multiport laparoscopy to natural orifice transluminal endoscopic surgery (NOTES) and, more recently, to single-port access (SPA). In this paper, we describe our technique for SPA splenectomy and provide a critical review of the current literature on SPA for splenic diseases.Preliminary results published to date indicate that the spleen can be safely removed using single-incision surgery and all the authors have unanimously endorsed the feasibility of this approach. However, available evidence is still scarce. It is based only on case reports and one small series, with a total of 17 patents and, therefore, firm conclusions cannot yet be drawn and more experience and comparative trials are needed to determine the exact role of this interesting new approach

Colonic stenting as a bridge to surgery versus emergency surgery for malignant colonic obstruction: results of a multicentre randomised controlled trial (ESCO trial)

BACKGROUND: The aim of colonic stenting with self-expandable metallic stents in neoplastic colon obstruction is to avoid emergency surgery and thus potentially reduce morbidity, mortality, and need for a stoma. Concern has been raised, however, about the effect of colonic stenting on short-term complications and long-term survival. We compared morbidity rates after colonic stenting as a bridge to surgery (SBTS) versus emergency surgery (ES) in the management of left-sided malignant large-bowel obstruction. METHODS: This multicentre randomised controlled trial was designed with the endorsement of the European Association for Endoscopic Surgery. The study population was consecutive patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin. The primary outcome was overall morbidity within 60 days after surgery. RESULTS: Between March 2008 and November 2015, 144 patients were randomly assigned to undergo either SBTS or ES; 29/144 (13.9%) were excluded post-randomisation mainly because of wrong diagnosis at computed tomography examination. The remaining 115 patients (SBTS n = 56, ES n = 59) were deemed eligible for analysis. The complications rate within 60 days was 51.8% in the SBTS group and 57.6% in the ES group (p = 0.529). Although long-term follow-up is still ongoing, no statistically significant difference in 3-year overall survival (p = 0.998) and progression-free survival rates between the groups has been observed (p = 0.893). Eleven patients in the SBTS group and 23 in the ES group received a stoma (p = 0.031), with a reversal rate of 30% so far. CONCLUSIONS: Our findings indicate that the two treatment strategies are equivalent. No difference in oncologic outcome was found at a median follow-up of 36 months. The significantly lower stoma rate noted in the SBTS group argues in favour of the SBTS procedure when performed in expert hands