Home care/outpatient versus hospital admission in mild acute pancreatitis: protocol of a multicentre, randomised controlled trial (PADI_2 trial).

INTRODUCTION: Acute pancreatitis (AP) is the third most common gastrointestinal disease resulting in hospital admission, with over 70% of AP admissions being mild cases. In the USA, it costs 2.5 billion dollars annually. The most common standard management of mild AP (MAP) still is hospital admission. Patients with MAP usually achieve complete recovery in less than a week and the severity predictor scales are reliable. The aim of this study will be to compare three different strategies for the management of MAP. METHODS/DESIGN: This is a randomised, controlled, three-arm multicentre trial. Patients with MAP will be randomly assigned to group A (outpatient), B (home care) or C (hospital admission). The primary endpoint of the trial will be the treatment failure rate of the outpatient/home care management for patients with MAP compared with that of hospitalised patients. The secondary endpoints will be pain relapse, diet intolerance, hospital readmission, hospital length of stay, need for intensive care unit admission, organ failure, complications, costs and patient satisfaction. The general feasibility, safety and quality checks required for high-quality evidence will be adhered to. ETHICS AND DISSEMINATION: The study (version 3.0, 10/2022) has been approved by the Scientific and Research Ethics Committee of the 'Institut d'Investigació Sanitaria Pere Virgili-IISPV' (093/2022). This study will provide evidence as to whether outpatient/home care is similar to usual management of AP. The conclusions of this study will be published in an open-access journal. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov Registry (NCT05360797).

Preliminary experience with a new robotic technique to facilitate distal pancreatectomy with spleen preservation: left lateral approach in right lateral decubitus position.

Spleen-preserving distal pancreatectomy (SP-DP), for patients with benign or small low-grade malignant tumors of the body or tail of the pancreas, is the ideal procedure although it is technically demanding. The robotic da Vinci system has been introduced to overcome these technical challenges and reduce operative risks. We report our experience of a new variation in surgical technique: the left lateral approach robotic spleen-preserving distal pancreatectomy (RSP-DP) in right lateral decubitus position. We performed this new variant of SP-DP, in five patients, using the da Vinci Xi system. Technical and clinical feasibility are described. The mean age and body mass index were 53.4 years and 31.4 kg/m2, respectively. The mean total operative time was 323 min. The estimated mean blood loss was 240 ml. In all patients, the spleen could be preserved. In four patients, the splenic vessels were also preserved. One patient required a Warshaw technique due to significant fibrosis attached to the splenic vein. The postoperative period of all patients was uneventful except the presence of biochemical leak (BL) in two patients that only required maintenance of the drainage at home. The mean length of hospital stay was 6 days after surgery. The left lateral approach robotic SP-DP in right lateral decubitus position is a feasible and safe procedure for distal benign or small low-grade malignant tumors of the left pancreas. The right lateral decubitus position associated to robotic surgery can facilitate this complex procedure, especially when splenic vessels preservation is indicated, with a lower risk of conversion and shortening of the learning curve.

Randomised clinical trial to test the phenolization in sacrococcygeal pilonidal disease.

To test the efficacy and safety of phenolization in uncomplicated Sacrococcygeal pilonidal disease (SPD) the phenolization in uncomplicated SPD is feasible and secure in selected patients in observational studies. The greatest benefits are obtained to reduce the length of sick leave (LSL) and complications. Single-center randomised controlled clinical trial. Patients were recruited at University Hospital of Tarragona Joan XXIII of Spain. Patients were randomised into two treatment groups. All patients with uncomplicated sacrococcygeal disease, localised in the midline and with only 1 fistulous orifice. The patients were randomly assigned to the phenolization group (PhG) or conventional-surgery group (CsG). Both groups were managed without admission. The main endpoint was the recurrence of sacrococcygeal disease. Secondary endpoints included time of sick leave, complications, and readmission. 124 patients were included in the study. No disease recurrence was observed in either group. Clinical follow-up was carried out with a mean of 493.8 days (SD 6.59). The LSL was shorter in the PhG (mean 19.63 days, SD 28.15) than in the CSG (43.95 days, SD 38.60). The LSL reduction was -24.31 days (P .002). The phenolization in selected SPD is a safe and feasible procedure in selected patients. This approach could become the standard of care for patients with selected Sacrococcygeal pilonidal.

Outpatient management of acute uncomplicated appendicitis after laparoscopic appendectomy: a randomized controlled trial.

OBJECTIVE: To confirm the safety and efficacy of outpatient management of laparoscopic appendectomy, with an enhanced recovery after surgery (ERAS) protocol, in adult patients with uncomplicated acute appendicitis. Outpatient laparoscopic appendectomy is feasible and secure in selected patients in observational studies. The benefits include reduced length of stay (LOS) and postoperative complications. This is the first randomized controlled trial of outpatient management following ERAS protocol. METHODS: Patients admitted from the emergency department with acute appendicitis were randomized into one of two groups: standard care within the hospital (HG) or the outpatient group (OG). An ERAS protocol was followed for both groups. Patients in the HG were admitted to the surgical ward. Patients in the OG were referred to the day-surgery unit. The primary endpoint was the length of stay. RESULTS: Ninety-seven patients were included: 49 in the OG and 48 in the HG. LOS was significantly shorter in the OG (mean 8.82 h) than in the HG (mean 43.53 h), p < 0.001. There was no difference in readmission rates (p = 0.320); we observed only one readmission in the OG. No further emergency consultations or complications were observed. The cost saving was $516.52/patient as a result of the intervention. CONCLUSION: Outpatient management of appendectomy is safe and feasible procedure in selected patients. This approach could become the standard of care for patients with uncomplicated appendicitis, showing fewer complications, lower LOS and cost. TRIAL REGISTRATION: Registration: www. CLINICALTRIALS: gov (NCT05401188) Clinical Trial ID: NCT05401188.

New Insights of OLFM2 and OLFM4 in Gut-Liver Axis and Their Potential Involvement in Nonalcoholic Fatty Liver Disease.

Olfactomedins (OLFMs) are a family of glycoproteins that play a relevant role in embryonic development and in some pathological processes. Although OLFM2 is involved in the regulation of the energy metabolism and OLFM4 is an important player in inflammation, innate immunity and cancer, the role of OLFMs in NAFLD-related intestinal dysbiosis remains unknown. In this study, we analysed the hepatic mRNA expression of OLFM2 and the jejunal expression of OLFM4 in a well-established cohort of women with morbid obesity (MO), classified according to their hepatic histology into normal liver (n = 27), simple steatosis (n = 26) and nonalcoholic steatohepatitis (NASH, n = 16). Our results showed that OLFM2 hepatic mRNA was higher in NASH, in advanced degrees of steatosis and in the presence of lobular inflammation. Additionally, we obtained positive correlations between hepatic OLFM2 and glucose, cholesterol, trimethylamine N-oxide and deoxycholic acid levels and hepatic fatty acid synthase, and negative associations with weight and jejunal Toll-like receptors (TLR4) and TLR5 expression. Regarding jejunal OLFM4, we observed positive correlations with circulating interleukin (IL)-8, IL-10, IL-17 and jejunal TLR9. In conclusion, OLFM2 in the liver seems to play a relevant role in NAFLD progression, while OLFM4 in the jejunum could be involved in gut dysbiosis-related inflammatory events.

Application of emerging technologies to obtain legume protein isolates with improved techno-functional properties and health effects.

Current demand of consumers for healthy and sustainable food products has led the industry to search for different sources of plant protein isolates and concentrates. Legumes represent an excellent nonanimal protein source with high-protein content. Legume species are distributed in a wide range of ecological conditions, including regions with drought conditions, making them a sustainable crop in a context of global warming. However, their use as human food is limited by the presence of antinutritional factors, such as protease inhibitors, lectins, phytates, and alkaloids, which have adverse nutritional effects. Antitechnological factors, such as fiber, tannins, and lipids, can affect the purity and protein extraction yield. Although most are removed or reduced during alkaline solubilization and isoelectric precipitation processes, some remain in the resulting protein isolates. Selection of appropriate legume genotypes and different emerging and sustainable facilitating technologies, such as high-power ultrasound, pulsed electric fields, high hydrostatic pressure, microwave, and supercritical fluids, can be applied to increase the removal of unwanted compounds. Some technologies can be used to increase protein yield. The technologies can also modify protein structure to improve digestibility, reduce allergenicity, and tune technological properties. This review summarizes recent findings regarding the use of emerging technologies to obtain high-purity protein isolates and the effects on techno-functional properties and health.

Protective properties of grape-seed proanthocyanidins in human ex vivo acute colonic dysfunction induced by dextran sodium sulfate.

PURPOSE: Anti-inflammatory and barrier-protective properties have been attributed to proanthocyanidins in the context of intestinal dysfunction, however little information is available about the impact of these phytochemicals on intestinal barrier integrity and immune response in the human. Here we assessed the putative protective properties of a grape-seed proanthocyanidin extract (GSPE) against dextran sodium sulfate (DSS)-induced acute dysfunction of the human colon in an Ussing chamber system. METHODS: Human proximal and distal colon tissues from colectomized patients were submitted ex vivo for a 30-min preventive GSPE treatment (50 or 200 µg mL-1) followed by 1-h incubation with DSS (12% w v-1). Transepithelial electrical resistance (TEER), permeation of a fluorescently-labeled dextran (FD4) and proinflammatory cytokine release [tumor necrosis factor (TNF)-α and interleukin (IL)-1ß] of colonic tissues were determined. RESULTS: DSS reduced TEER (45-52%) in both the proximal and distal colon; however, significant increments in FD4 permeation (fourfold) and TNF-α release (61%) were observed only in the proximal colon. The preventive GSPE treatment decreased DSS-induced TEER loss (20-32%), FD4 permeation (66-73%) and TNF-α release (22-33%) of the proximal colon dose-dependently. The distal colon was not responsive to the preventive treatment but showed a reduction in IL-1ß release below basal levels with the highest GSPE concentration. CONCLUSIONS: Our results demonstrate potential preventive effects of GSPE on human colon dysfunction. Further studies are required to test whether administering GSPE could be a complementary therapeutic approach in colonic dysfunction associated with metabolic disorders and inflammatory bowel disease.

Gastrointestinally Digested Protein from the Insect Alphitobius diaperinus Stimulates a Different Intestinal Secretome than Beef or Almond, Producing a Differential Response in Food Intake in Rats.

In this study we compare the interaction of three protein sources-insect, beef, and almond-with the gastrointestinal tract. We measured the enterohormone secretion ex vivo in human and pig intestine treated with in vitro digestions of these foods. Insect and beef were the most effective in inducing the secretion of CCK, while almond was the most effective in inducing PYY in pig duodenum. In the human colon, almond was also the most effective in inducing PYY, and GLP-1 levels were increased by insect and beef. The three digested proteins reduced ghrelin secretion in pig duodenum, while only insect reduced ghrelin secretion in human colon. We also found that food intake in rats increased in groups fed a raw insect pre-load and decreased when fed raw almond. In conclusion, the insect Alphitobius diaperinus modulates duodenal and colonic enterohormone release and increases food intake in rats. These effects differ from beef and almond.

Effects of Flavanols on Enteroendocrine Secretion.

Some beneficial effects of grape seed proanthocyanidin extract (GSPE) can be explained by the modulation of enterohormone secretion. As GSPE comprises a combination of different molecules, the pure compounds that cause these effects need to be elucidated. The enterohormones and chemoreceptors present in the gastrointestinal tract differ between species, so if humans are to gain beneficial effects, species closer to humans-and humans themselves-must be used. We demonstrate that 100 mg/L of GSPE stimulates peptide YY (PYY) release, but not glucagon-like peptide 1 (GLP-1) release in the human colon. We used a pig ex vivo system that differentiates between apical and basolateral intestinal sides to analyse how apical stimulation with GSPE and its pure compounds affects the gastrointestinal tract. In pigs, apical GSPE treatment stimulates the basolateral release of PYY in the duodenum and colon and that of GLP-1 in the ascending, but not the descending colon. In the duodenum, luminal stimulation with procyanidin dimer B2 increased PYY secretion, but not CCK secretion, while catechin monomers (catechin/epicatechin) significantly increased CCK release, but not PYY release. The differential effects of GSPE and its pure compounds on enterohormone release at the same intestinal segment suggest that they act through chemosensors located apically and unevenly distributed along the gastrointestinal tract.

Valoración del impacto de la educación preoperatoria en la colecistectomía laparoscópica ambulatoria. Ensayo prospectivo aleatorizado doble ciego / Evaluation of the impact of preoperative education in ambulatory laparoscopic cholecystectomy. A prospective, double-blind randomized trial

Introducción: La colecistectomía laparoscópica ambulatoria es segura y proporciona mejor aprovechamiento de recursos sanitarios y satisfacción percibida, sin repercutir en la calidad asistencial. La educación preoperatoria ha demostrado disminución del estrés, del dolor y náuseas postoperatorios en algunas intervenciones. El objetivo principal del estudio es valorar el impacto de la educación preoperatoria sobre el dolor postoperatorio en la colecistectomía laparoscópica ambulatoria. Los objetivos secundarios fueron evaluar las náuseas postoperatorias, morbilidad, ingresos no esperados, readmisiones, calidad de vida y grado de satisfacción. Métodos: Estudio prospectivo, aleatorizado, doble ciego. Entre abril de 2014 y mayo de 2016 fueron intervenidos 62 pacientes de colecistectomía laparoscópica ambulatoria. Criterios de inclusión: ASA I-II, edad 18-75 años, criterios de ambulatorización, ecografía abdominal con colelitiasis. Aleatorización de pacientes en grupo A: educación preoperatoria intensificada, y grupo B: control. Resultados: Sesenta y dos pacientes incluidos, 44 mujeres (71%), 18 hombres (29%), edad media 46,8 años (20-69). Media IMC de 27,5. Tasa de ambulatorización del 92%, 5 casos requirieron ingreso, 2 fueron por náuseas. La media del grado de dolor según EVA fue a las 24 h de 2,9 en el grupo A y de 2,7 en el grupo B. No complicaciones graves ni reingresos. La encuesta de satisfacción y el test de calidad de vida no mostraron diferencias entre grupos. Conclusiones: Las bajas cifras de dolor y complicaciones impiden evidenciar diferencias atribuibles a la educación preoperatoria. Sin embargo, un correcto protocolo de información se debería integrar en la preparación preoperatoria de los pacientes (AU)

Introduction: Outpatient laparoscopic cholecystectomy is a safe procedure and provides a better use of health resources and perceived satisfaction without affecting quality of care. Preoperative education has shown less postoperative stress, pain and nausea in some interventions. The principal objective of this study is to assess the impact of preoperative education on postoperative pain in patients undergoing ambulatory laparoscopic cholecystectomy. Secondary objectives were: to evaluate presence of nausea, morbidity, hospital admissions, readmissions rate, quality of life and satisfaction. Methods: Prospective, randomized, and double blind study. Between April 2014 and May 2016, 62 patients underwent outpatient laparoscopic cholecystectomy. Inclusion criteria: ASA I-II, age 18-75, outpatient surgery criteria, abdominal ultrasonography with cholelithiasis. Patient randomization in two groups, group A: intensified preoperative education and group B: control. Results: Sixty-two patients included, 44 women (71%), 18 men (29%), mean age 46,8 years (20-69). Mean BMI 27,5. Outpatient rate 92%. Five cases required admission, two due to nausea. Pain scores obtained using a VAS was at 24-hour, 2,9 in group A and 2,7 in group B. There were no severe complications or readmissions. Results of satisfaction and quality of life scores were similar for both groups. Conclusions: We did not find differences due to intensive preoperative education. However, we think that a correct information protocol should be integrated into the patient's preoperative preparation (AU)

Evaluation of the impact of preoperative education in ambulatory laparoscopic cholecystectomy. A prospective, double-blind randomized trial. / Valoración del impacto de la educación preoperatoria en la colecistectomía laparoscópica ambulatoria. Ensayo prospectivo aleatorizado doble ciego.

INTRODUCTION: Outpatient laparoscopic cholecystectomy is a safe procedure and provides a better use of health resources and perceived satisfaction without affecting quality of care. Preoperative education has shown less postoperative stress, pain and nausea in some interventions. The principal objective of this study is to assess the impact of preoperative education on postoperative pain in patients undergoing ambulatory laparoscopic cholecystectomy. Secondary objectives were: to evaluate presence of nausea, morbidity, hospital admissions, readmissions rate, quality of life and satisfaction. METHODS: Prospective, randomized, and double blind study. Between April 2014 and May 2016, 62 patients underwent outpatient laparoscopic cholecystectomy. INCLUSION CRITERIA: ASA I-II, age 18-75, outpatient surgery criteria, abdominal ultrasonography with cholelithiasis. Patient randomization in two groups, group A: intensified preoperative education and group B: control. RESULTS: Sixty-two patients included, 44 women (71%), 18 men (29%), mean age 46,8 years (20-69). Mean BMI 27,5. Outpatient rate 92%. Five cases required admission, two due to nausea. Pain scores obtained using a VAS was at 24-hour, 2,9 in group A and 2,7 in group B. There were no severe complications or readmissions. Results of satisfaction and quality of life scores were similar for both groups. CONCLUSIONS: We did not find differences due to intensive preoperative education. However, we think that a correct information protocol should be integrated into the patient's preoperative preparation. Registered in ISRCTN number ISRCTN83787412.

Resultados de las 100 primeras colecistectomías por puerto único en un hospital de segundo nivel / Results of the first 100 single port laparoscopic cholecystectomies in a secondary care hospital

INTRODUCCIÓN: Aunque los resultados de la colecistectomía laparoscópica estándar son excelentes, se continúa intentando minimizar el número de puertos con el objeto de disminuir el dolor postoperatorio, conseguir una recuperación más temprana y mejorar el resultado estético del paciente. El objetivo de este estudio es presentar los resultados de los primeros 100 casos de colecistectomía por puerto único practicados en un hospital de segundo nivel. MATERIAL Y MÉTODOS: Estudio prospectivo, observacional, unicéntrico. Se intervino a 100 pacientes entre enero de 2010 y abril de 2012. CRITERIOS DE INCLUSIÓN: pacientes mayores de 16 años con colelitiasis sintomática operados por colecistectomía simple mediante incisión umbilical única. Criterios de exclusión: antecedentes de colecistitis aguda, colangiopancreatografía retrógrada endoscópica, pancreatitis o sospecha de coledocolitiasis, IMC > 35 y laparotomías previas. Se estudiaron distintas variables epidemiológicas, quirúrgicas y de seguridad. RESULTADOS: La edad media de los pacientes fue de 39,89 ± 11,5 años. El tiempo quirúrgico medio fue de 67,94 ± 25,5 min. Presentaron complicaciones postoperatorias 2 pacientes: seroma y fuga biliar. En 2 casos fue necesaria la utilización de trocar accesorio. La estancia media fue de 1,13 ± 0,8 días. El 35% de los pacientes fueron tratados en régimen de cirugía mayor ambulatoria. Todos los pacientes se mostraron muy satisfechos con el resultado estético. CONCLUSIONES: La colecistectomía mediante incisión umbilical única es una buena técnica cuando se utiliza en casos seleccionados y por cirujanos expertos. Puede facilitar la práctica de la colecistectomía en régimen ambulatorio. No se han presentado complicaciones graves. El índice de satisfacción estética es muy elevado

INTRODUCTION: Despite the excellent results obtained with standard laparoscopic cholecystectomy, the efforts for minimizing the ports needed to reduce postoperative pain, for a quicker recovery and to improve the patient's cosmetics continue. The aim of this study is to report the results of the first 100 cases of single port laparoscopic cholecystectomy performed in a secondary care hospital. MATERIAL AND METHODS: Prospective, observational and unicentric study including 100 patients between January 2010 and April 2012. Inclusion criteria: symptomatic cholelythiasis patients over 16 years of age on whom a single port laparoscopic cholecystectomy was performed. Exclusion criteria: history of acute cholecystitis, pancreatitis or suspected choledocholithiasis, Endoscopic retrograde cholangiopancreatography, BMI > 35 and previous laparotomies. We studied epidemiological, surgical and safety variables. RESULTS: The mean patient age was 39.89 ± 11.5 years. The mean time of the surgical procedure was 67.94 ± 25.5 min. There were 2 cases of postoperative complications: a non-infected seroma and a biliar leak. In 2 cases the use of an accessory trocar was needed. The mean hospital stay was 1.13 ± 0.8 days. A total of 35% patients were included in the major ambulatory surgery program. The overall patient satisfaction survey rating showed a high level of cosmetic satisfaction in 100% of patients. CONCLUSIONS: Single port laparoscopic cholecystectomy is a good technique when performed in selected cases by expert surgeons. It is feasible to include the single port laparoscopic cholecystectomy in a major ambulatory surgery program. We have not had serious complications. There is a high cosmetic satisfaction index with this technique

Results of the first 100 single port laparoscopic cholecystectomies in a secondary care hospital.

INTRODUCTION: Despite the excellent results obtained with standard laparoscopic cholecystectomy, the efforts for minimizing the ports needed to reduce postoperative pain, for a quicker recovery and to improve the patient's cosmetics continue. The aim of this study is to report the results of the first 100 cases of single port laparoscopic cholecystectomy performed in a secondary care hospital. MATERIAL AND METHODS: Prospective, observational and unicentric study including 100 patients between January 2010 and April 2012. INCLUSION CRITERIA: symptomatic cholelythiasis patients over 16-years of age on whom a single port laparoscopic cholecystectomy was performed. EXCLUSION CRITERIA: history of acute cholecystitis, pancreatitis or suspected choledocholithiasis, Endoscopic retrograde cholangiopancreatography, BMI>35 and previous laparotomies. We studied epidemiological, surgical and safety variables. RESULTS: The mean patient age was 39,89 ± 11,5 years. The mean time of the surgical procedure was 67,94 ± 25,5 min. There were 2 cases of postoperative complications. A non-infected seroma and a biliar leak. In 2 cases the use of an accessory trocar was needed. The mean hospital stay was 1,13 ± 0,8 days. A total of 35% patients were included in the major ambulatory surgery programme.The overall patient satisfaction survey rating showed a high level of cosmetic satisfaction in 100% of patients. CONCLUSIONS: Single port laparoscopic cholecystectomy is a good technique when performed in selected cases by expert surgeons. It is feasible to include the single port laparoscopic cholecystectomy in a major ambulatory surgery programme. We have not had serious complications. There is a high cosmetic satisfaction index with this technique.