Long-term outcomes and risk factors for diverticulitis recurrence after a successful laparoscopic peritoneal lavage in Hinchey III peritonitis.

PURPOSE: Recently, treatment of Hinchey III diverticulitis by laparoscopic peritoneal lavage has been questioned. Moreover, long-term outcomes have been scarcely reported. Primary outcome was to determine the recurrence rate of diverticulitis after a successful laparoscopic peritoneal lavage in Hinchey III diverticulitis. Secondary outcomes were identification of associated risk factors for recurrence and elective sigmoidectomy rate. METHODS: A retrospective cohort study in a tertiary referral center was performed. Patients with Hinchey III diverticulitis who underwent a successful laparoscopic peritoneal lavage between June 2006 and December 2019 were eligible. Diverticulitis recurrence was analyzed according to the Kaplan-Meier and log-rank test, censoring for death, loss of follow-up, or elective sigmoid resection in the absence of recurrence. Risk factors for recurrence were identified using Cox regression analysis. RESULTS: Sixty-nine patients had a successful laparoscopic peritoneal lavage (mean age: 63 years; 53.6% women). Four patients had an elective sigmoid resection without recurrences. Recurrence rate was 42% (n = 29) after a median follow-up of 63 months. The cumulative global recurrence at 1, 3, and 5 years was 30% (95% CI, 20-43%), 37.5% (95% CI, 27-51%), and 48.9% (95% CI, 36-64%), respectively. Smoking (HR, 2.87; 95% CI, 1.22-6.5; p = 0.016) and episodes of diverticulitis prior to laparoscopic peritoneal lavage (HR, 5.2; 95% CI, 2.11-12.81; p < 0.001) were independently associated with an increased risk of recurrence. CONCLUSIONS: Diverticulitis recurrence after a successful laparoscopic peritoneal lavage is high, decreasing after the first year of follow-up. Smoking and previous episodes of acute diverticulitis independently increase the risk of new episodes of diverticulitis.

Benchmarks in colorectal surgery: multinational study to define quality thresholds in high and low anterior resection.

BACKGROUND: Benchmark comparisons in surgery allow identification of gaps in the quality of care provided. The aim of this study was to determine quality thresholds for high (HAR) and low (LAR) anterior resections in colorectal cancer surgery by applying the concept of benchmarking. METHODS: This 5-year multinational retrospective study included patients who underwent anterior resection for cancer in 19 high-volume centres on five continents. Benchmarks were defined for 11 relevant postoperative variables at discharge, 3 months, and 6 months (for LAR). Benchmarks were calculated for two separate cohorts: patients without (ideal) and those with (non-ideal) outcome-relevant co-morbidities. Benchmark cut-offs were defined as the 75th percentile of each centre's median value. RESULTS: A total of 3903 patients who underwent HAR and 3726 who had LAR for cancer were analysed. After 3 months' follow-up, the mortality benchmark in HAR for ideal and non-ideal patients was 0.0 versus 3.0 per cent, and in LAR it was 0.0 versus 2.2 per cent. Benchmark results for anastomotic leakage were 5.0 versus 6.9 per cent for HAR, and 13.6 versus 11.8 per cent for LAR. The overall morbidity benchmark in HAR was a Comprehensive Complication Index (CCI®) score of 8.6 versus 14.7, and that for LAR was CCI® score 11.9 versus 18.3. CONCLUSION: Regular comparison of individual-surgeon or -unit outcome data against benchmark thresholds may identify gaps in care quality that can improve patient outcome.

Laparoscopic-guided distal loco-regional anesthetic infiltration technique in TAPP inguinal hernia repair: a double-blind randomized clinical trial.

BACKGROUND: Ultrasound-guided transversus abdominis plane block (US-TAP) is an important component of multimodal analgesia in laparoscopic inguinal hernia repair, although it has certain limitations. To overcome them, surgeons have developed several techniques to perform local anesthetic infiltration under laparoscopic guidance, but no trials evaluating these in transabdominal preperitoneal (TAPP) hernia repair were conducted till the date. The aim of this study was to compare the efficacy of a novel laparoscopic-guided local anesthetic infiltration technique (LDAI) with US-TAP in postoperative pain control and analgesic consumption for patients undergoing elective TAPP hernia repair. METHODS: This was a double-blind randomized controlled trial conducted at a single tertiary academic center between 2019 and 2020 on adult patients undergoing elective laparoscopic TAPP inguinal hernia repair. Postoperative pain and analgesic consumption were compared for LDAI vs. US-TAP up to 30 postoperative days. RESULTS: 62 patients were included (31 LDAI, 31 US-TAP). Female gender was significantly higher in the LDAI group (8, 25.81%; US-TAP 0; p = 0.005). Mean anesthetic time (US-TAP group: 142.2 min, SD = 17.7; LDAI group: 127.1 min, SD = 15.5; p < 0.001) and mean operative time (US-TAP group: 117.2 min, SD = 15.9; LDAI group: 103.8 min, SD = 15.2; p < 0.001) were significantly shorter in the LDAI group. Pain scores assessed at the first-hour postoperative, at the moment of discharge, and at 8, 24, and 48 postoperative hours showed no significant differences between both groups. No significant difference was found regarding postoperative analgesic rescue administration in the recovery room and analgesic consumption after discharge between groups. CONCLUSION: LDAI is a safe and effective local anesthetic technique in elective TAPP hernia repair. Pain control is similar to US-TAP block, with shorter anesthesthetic and surgical time and better health resources allocation.

Right versus left laparoscopic colectomy for colon cancer: does side make any difference?

PURPOSE: To compare the intraoperative and postoperative outcomes between right laparoscopic colectomy (RLC) and left laparoscopic colectomy (LLC) for colon cancer. METHOD: Patients who underwent elective RLC or LLC for colon cancer between January 2004 and December 2014 were identified and elected for a retrospective analysis. Primary outcomes were technical difficulty (including operative time, intraoperative complications, and conversion rate) and postoperative outcome (including postoperative complications, length of hospital stay, reinterventions, readmissions, and mortality). RESULTS: A total of 547 patients (mean age: 68.5 years old; 48.4% males) were analyzed. The RLC group had a higher mean age (71 vs 65; p < 0.001), ASA 3/4 grade (36 vs 26%; p = 0.02), and comorbidity rate (61 vs 48%, p = 0.003). Regarding technical difficulty, no difference was found between the groups in intraoperative complications (4.1 vs 5.9%; p = 0.34) or conversion rate (6.2 vs 3.9%, p = 0.24). Mean operative time was significantly shorter for RLC (162 vs 185 min, p < 0.001). Regarding postoperative outcome, the RLC group had a higher overall morbidity (20.5 vs 13.3%, p = 0.03), ileus (10.6 vs 2.4%, p < 0.001), and a longer hospital stay (4.7 vs 3.9 days, p = 0.003), with no differences regarding reoperations, readmissions, or mortality. The multivariate analysis showed that RLC were independently associated with a longer operative time and postoperative ileus. CONCLUSIONS: RLC for colon cancer was independently associated with a shorter operative time, an increased risk of ileus, and a longer hospital stay than left laparoscopic colectomy in high-volume centers.

[Retroperitoneal schwannoma mimicking colorectal cancer metastases: a false positive result report.] / Schwannoma retroperitoneal simulando metástasis de cáncer colorrectal: reporte de un resultado falso positivo.

Introduction: schwannomas are benign and common soft tissue tumors. They are usually asymptomatic and are discovered for other reasons. Materials: we present the case of an 82-year-old male patient with a recent diagnosis of moderately differentiated adenocarcinoma of the colon and a hypermetabolic periaortic nodule as an incidental finding. Results: percutaneous biopsy of the periaortic nodule confirmed the diagnosis of schwannoma. At one year of follow-up, growth of the schwannoma has been demonstrated. There are no signs of progression of his oncological disease. Conclusions: schwannomas are benign tumors, rarely found in the retroperitoneum and can be sources of false-positive positron emission tomography results.

Introducción: los schwannomas son tumores benignos y frecuentes de las partes blandas. Habitualmente son asintomáticos y son descubiertos por otros motivos. Materiales y métodos: presentamos el caso de un paciente masculino de 82 años con diagnóstico reciente de adenocarcinoma de colon moderadamente diferenciado y con un nódulo periaórtico hipermetabólico como hallazgo incidental. Resultados: la biopsia percutánea del nódulo periaórtico confirmó el diagnóstico de schwannoma. Al año de seguimiento, se ha demostrado crecimiento del schwannoma. No hay signos de progresión de su enfermedad oncológica. Conclusión: los schwannomas son tumores benignos, infrecuentes en el retroperitoneo y pueden ser fuentes de resultados falsos positivos en tomografía por emisión de positrones.

Goodbye Hartmann trial: a prospective, international, multicenter, observational study on the current use of a surgical procedure developed a century ago.

BACKGROUND: Literature suggests colonic resection and primary anastomosis (RPA) instead of Hartmann's procedure (HP) for the treatment of left-sided colonic emergencies. We aim to evaluate the surgical options globally used to treat patients with acute left-sided colonic emergencies and the factors that leading to the choice of treatment, comparing HP and RPA. METHODS: This is a prospective, international, multicenter, observational study registered on ClinicalTrials.gov. A total 1215 patients with left-sided colonic emergencies who required surgery were included from 204 centers during the period of March 1, 2020, to May 31, 2020. with a 1-year follow-up. RESULTS: 564 patients (43.1%) were females. The mean age was 65.9 ± 15.6 years. HP was performed in 697 (57.3%) patients and RPA in 384 (31.6%) cases. Complicated acute diverticulitis was the most common cause of left-sided colonic emergencies (40.2%), followed by colorectal malignancy (36.6%). Severe complications (Clavien-Dindo ≥ 3b) were higher in the HP group (P < 0.001). 30-day mortality was higher in HP patients (13.7%), especially in case of bowel perforation and diffused peritonitis. 1-year follow-up showed no differences on ostomy reversal rate between HP and RPA. (P = 0.127). A backward likelihood logistic regression model showed that RPA was preferred in younger patients, having low ASA score (≤ 3), in case of large bowel obstruction, absence of colonic ischemia, longer time from admission to surgery, operating early at the day working hours, by a surgeon who performed more than 50 colorectal resections. CONCLUSIONS: After 100 years since the first Hartmann's procedure, HP remains the most common treatment for left-sided colorectal emergencies. Treatment's choice depends on patient characteristics, the time of surgery and the experience of the surgeon. RPA should be considered as the gold standard for surgery, with HP being an exception.

Risk factors for major complications after surgical treatment of primary ileocecal Crohn's disease. A multicentric Latin American experience.

INTRODUCTION: Complications after ileocecal resection for Crohn's disease (CD) are frequent. The aim of this study was to analyze risk factors for postoperative complications after these procedures. MATERIALS AND METHODS: We conducted a retrospective analysis of patients treated surgically for Crohn's disease limited to the ileocecal region during an 8-year period at 10 medical centers specialized in inflammatory bowel disease (IBD) in Latin America. Patients were allocated into 2 groups: those who presented major postoperative complications (Clavien-Dindo > II), the "postoperative complication" (POC) group; and those who did not, the "no postoperative complication" (NPOC) group. Preoperative characteristics and intraoperative variables were analyzed to identify possible factors for POC. RESULTS: In total, 337 patients were included, with 51 (15.13%) in the POC cohort. Smoking was more prevalent among the POC patients (31.37 vs. 17.83; P = .026), who presented more preoperative anemia (33.33 vs. 17.48%; P = .009), required more urgent care (37.25 vs. 22.38; P = .023), and had lower albumin levels. Complicated disease was associated with higher postoperative morbidity. POC patients had a longer operative time (188.77 vs. 143.86 min; P = .005), more intraoperative complications (17.65 vs. 4.55%; P < .001), and lower rates of primary anastomosis. In the multivariate analysis, both smoking and intraoperative complications were independently associated with the occurrence of major postoperative complications. CONCLUSION: This study shows that risk factors for complications after primary ileocecal resections for Crohn's disease in Latin America are similar to those reported elsewhere. Future efforts in the region should be aimed at improving these outcomes by controlling some of the identified factors.

[Hand-assisted Laparoscopic Surgery: experience with an original technique]. / Cirugía colorrectal laparoscópica mano asistida: experiencia con una técnica original.

Introduction: Hand-assisted laparoscopic colorectal surgery (HALS) is an alternative to straight laparoscopic approach (SL) that requires the use of a specific device to maintain the pneumoperitoneum. Our group has described an original double glove technique to replace it. Our purpose was to compare perioperative outcomes of patients undergoing HALS using this original technique vs SL. Methods: Retrospective review of a prospective database including patients who underwent elective laparoscopic colorectal resections between 2004 to 2020 at the Hospital Italiano, Argentina. Logistic regression analysis, propensity score matching, and inverse probability weighting were used to estimate adjusted treatment effects for perioperative outcomes. Results: HALS (n=458) and SL (n=1692) cases were demographically similar. HALS was associated with a shorter operative time (170.3 vs 206.9 minutes, p<0.001). Such difference was even more pronounced in obese (44.1 min), large patients (37.5 min), complex procedures (33.8 min) and surgeries carried out by non-trained surgeons (57,6 vs 31,6 minutes, p<0.001). Hand-assisted was associated with a lower conversion rate (5% vs 9.9%, p<0.001) with an adjusted odds ratio of 0.45 (95%CI 0.28-0.73). No difference in hospital stay, morbidity, and readmission rates was found. Conclusions: HALS with double-glove technique is comparable to SL in terms of postoperative outcomes keeping reduced operative time and conversion rates, especially in obese patients undergoing complex procedures.

Introducción: La cirugía colorrectal laparoscópica mano asistida (CLMA) es un abordaje alternativo a la laparoscopia directa (LD) que requiere de un dispositivo específico para mantener el neumoperitoneo. Nuestro grupo describió una técnica original de doble guante como alternativa a este dispositivo. El objetivo del presente trabajo fue analizar los resultados de esta técnica comparándola con la técnica de LD. Métodos: Se analizó una serie consecutiva de pacientes sometidos a cirugías colorrectales laparoscópicas entre 2004 y 2020 en el Hospital Italiano de Bs, As, Argentina. Se realizó un modelo de regresión múltiple de selección progresiva y apareamiento por puntaje de propensión para analizar los resultados perioperatorios. Resultados: Los casos de CLMA (n=458) y LD (n=1692) fueron demográficamente similares. CLMA se asoció a un menor tiempo operatorio (170,3 vs 206,9 minutos, p<0.001). Dicha reducción fue más marcada en obesos (44.1 min), pacientes grandes (37.5 min), cirugías complejas (33.8 min) y en procedimientos realizados por cirujanos no entrenados (57,6 vs 31,6 minutos, p<0.001). CLMA resultó tener menor índice de conversión (5% vs 9.9%, p<0.001) con una razón de probabilidades ajustada de 0,45. No se hallaron diferencias en cuanto a estadía hospitalaria, morbimortalidad y readmisión. Conclusión: CLMA con doble guante es comparable a la LD manteniendo un tiempo operatorio reducido y bajo índice de conversión, particularmente en pacientes obesos sometidos a procedimientos complejos.

Variaciones anatómicas en la vascularización del colon derecho y su implicancia en la escisión completa del mesocolon con linfadenectomía D3. Estudio de corte transversal / Anatomical variations in right colon vascularization: its implication in complete mesocolic excision with D3 lymphadenectomy. A cross-sectional study

Introducción: La escisión completa del mesocolon con linfadenectomía D3 (CME-D3) mejora los resultados de los pacientes operados por cáncer del colon. Reconocer adecuadamente la anatomía vascular es fundamental para evitar complicaciones. Objetivo: El objetivo primario fue determinar la prevalencia de las variaciones anatómicas de la arteria mesentérica superior (AMS) y sus ramas en relación a la vena mesentérica superior (VMS). El objetivo secundario fue evaluar la asociación entre las distintas variantes anatómicas y el sexo y la etnia de lo pacientes. Diseño: Estudio de corte transversal. Material y métodos: Se incluyeron 225 pacientes con cáncer del colon derecho diagnosticados entre enero 2017 y diciembre de 2020. Dos radiólogos independientes describieron la anatomía vascular observada en las tomografías computadas. Según la relación de las ramas de la AMS con la VMS, la población fue dividida en 2 grupos y subdividida en 6 (1a-c, 2a-c). Resultados: La arteria ileocólica fue constante, transcurriendo en el 58,7% de los casos por la cara posterior de la VMS. La arteria cólica derecha, presente en el 39,6% de los pacientes, cruzó la VMS por su cara anterior en el 95,5% de los casos. La variante de subgrupo más frecuente fue la 2a seguida por la 1a (36,4 y 24%, respectivamente). No se encontró asociación entre las variantes anatómicas y el sexo u origen étnico. Conclusión: Las variaciones anatómicas de la AMS y sus ramas son frecuentes y no presentan un patrón predominante. No hubo asociación entre las mismas y el sexo u origen étnico en nuestra cohorte. El reconocimiento preoperatorio de estas variantes mediante angiotomografía resulta útil para evitar lesiones vasculares durante la CME-D3. (AU)

Background: Complete mesocolic excision with D3 lymphadenectomy (CME-D3) improves the outcomes of patients operated on for colon cancer. Proper recognition of vascular anatomy is essential to avoid complications. Aim: Primary outcome was to determine the prevalence of anatomical variations of the superior mesenteric artery (SMA) and its branches in relation to the superior mesenteric vein (SMV). Secondary outcome was to evaluate the association between these anatomical variations and sex and ethnicity of the patients. Design: Cross-sectional study. Material and methods: Two hundred twenty-fivepatients with right colon cancer diagnosed between January 2017 and December 2020 were included. Two independent radiologists described the vascular anatomy of computed tomography scans. The population was divided into 2 groups and subdivided into 6 groups (1a-c, 2a-c), according to the relationship of the SMA and its branches with the SMV. Results: The ileocolic artery was constant, crossing the SMV posteriorly in 58.7% of the cases. The right colic artery, present in 39.6% of the patients, crossed the SMV on its anterior aspect in 95.5% of the cases. The most frequent subgroup variant was 2a followed by 1a (36.4 and 24%, respectively). No association was found between anatomical variants and gender or ethnic origin. Conclusions: The anatomical variations of the SMA and its branches are common, with no predominant pattern. There was no association between anatomical variations and gender or ethnic origin in our cohort. Preoperative evaluation of these variations by computed tomography angi-ography is useful to avoid vascular injuries during CME-D3. (AU)

Heberprot-P's Effect on Gene Expression in Healing Diabetic Foot Ulcers.

NTRODUCTION Diabetic foot ulcers are a chronic complication in patients with diabetes mellitus. They appear as a result of the combination of diabetic polyneuropathy and angiopathy, and in many cases require amputation of the affected extremity. Clinical trials have demonstrated that repeated local infiltration with Heberprot-P can improve healing of chronic diabetic foot ulcers. Although there is evidence of its effects as a granulation stimulator and on cell migration and proliferation, genetic control mechanisms explaining its anti-inflammatory and oxidative stress reduction properties are not yet thoroughly understood. OBJECTIVE Analyze changes in expression of genes involved in healing after treatment of diabetic foot ulcers with Heberprot-P. METHODS Biopsies were collected from diabetic foot ulcers of 10 responding patients before and after 2 weeks' treatment with Heberprot-P (75-µg applied intralesionally 3 times per week). Total RNA was obtained and quantitative PCR used to determine expression of 26 genes related to inflammation, oxidative stress, cell proliferation, ngiogenesis and extracellular matrix formation. Genetic expression was quantified before and after treatment using REST 2009 v2.0.13. RESULTS After treatment, there was a statistically significant increase in expression of genes related to cell proliferation, angiogenesis and formation of extracellular matrix (PDGFB, CDK4, P21, TP53, ANGPT1, COL1A1, MMP2 and TIMP2). A significant decrease was observed in gene expression related to inflammatory processes and oxidative stress (NFKB1, TNFA and IL-1A). CONCLUSIONS Our findings suggest that Heberprot-P's healing action on diabetic foot ulcers is mediated through changes in genetic expression that reduce hypoxia, inflammation and oxidative stress, and at the same time increase cell proliferation, collagen synthesis and extracellular matrix remodeling. The kinetics of expression of two genes related to extracellular matrix formation needs further exploration. KEYWORDS Epidermal growth factor, EGF, diabetic foot ulcer, wound healing, quantitative real-time PCR, gene expression, Cuba.

Assessment of IL-28: rs12979860 and rs8099917 Polymorphisms in a Cohort of Cuban Chronic HCV Genotype 1b Patients.

Hepatitis C virus (HCV) is a significant global public health problem with >185 million infections worldwide. A series of genome-wide association studies (GWAS) has identified IL-28B polymorphisms as a predictor of sustained virologic response (SVR), as well as spontaneous clearance in chronic HCV genotype 1 patients. The objective of this work was to evaluate the prevalence of IL-28B rs12979860 and rs8099917 polymorphisms in Cuban chronic HCV patients. The study cohort included 73 chronic HCV patients treated with concomitant administration of CIGB-230 and nonpegylated IFN-α plus ribavirin (non-pegIFN-α/R) antiviral therapy. The genotype distribution of IL-28B rs12979860CC, -CT, and -TT was 29, 41, and 30%, respectively, and the distribution for rs8099917TT, -TG, and -GG was 63, 31, and 5%, respectively. The allele frequencies for rs12979860C and -T alleles were 51 and 49%, respectively, and for rs8099917G and -T alleles, the values were 21 and 79%, respectively. SVR rates were 55, 42, and 35% for rs12979860CC, -CT, and -TT, respectively, and 52, 30, and 25% for rs8099917TT, -GT, and -GG, respectively. The combined assessment of both single nucleotide polymorphisms (SNPs) resulted in 3 major genotypes (rs12979860CC/rs8099917TT, rs12979860CT/rs8099917TT, and rs12979860CT/rs8099917GG) with a frequency of 30.1, 21.9, and 20.5%, respectively. In patients with heterozygous variant rs12979860CT, the additional genotyping of rs8099917 contributed to increase the SVR rate. It is concluded that in Cuban HCV-infected patients, the responder homogeneous variant rs8099917TT is the most frequent genotype. The simultaneous genotyping of 2 IL-28B SNPs could improve the prediction of SVR contributing to better therapeutic decisions and treatment management.

Implementación de un programa ERAS® / Implementation of an ERAS® program

RESUMEN Enhanced Recovery After Surgery (ERAS) constituye una forma de trabajo que implica la puesta en marcha de medidas de cuidado antes, durante y después de una cirugía con el propósito de mejorar la experiencia del paciente a lo largo del periodo perioperatorio. Sin embargo, la aplicación aislada de medidas determinadas no es suficiente. Esta forma de trabajo requiere la creación de un equipo de trabajo multidisciplinario, el registro sistemático de datos y su utilización para aplicar un ciclo de mejora continua. En el Hospital Italiano de Buenos Aires, se han registrado 1331 pacientes desde no viembre del año 2015. La mediana de internación fue de 4 días y la readmisión de 7,3%. La adherencia global a las medidas del programa fue del 56% (preoperatorio 88%, intraoperatorio 60%, postopera torio 39%). En los procedimientos quirúrgicos más frecuentes pudimos observar una relación lineal e inversamente proporcional entre adherencia al programa y el tiempo de internación, con una dismi nución promedio de un día de internación por cada 10% de adherencia al programa en los procedi mientos quirúrgicos más frecuentes. A pesar de estos resultados, hemos encontrado dificultades en el sistema de registro de datos que limitan la aplicación del ciclo de mejora continua. La conformación de un equipo multidisciplinario, con una comunicación fluida y eficiente es fundamental para la imple mentación de un programa ERAS® que sea capaz de disminuir el tiempo de internación, la morbilidad y el índice de readmisión.

ABSTRACT Enhanced Recovery After Surgery (ERAS) is a model of care that involves the implementation of care pathways before, during and after surgery designed to improve patient's experience throughout the perioperative period. Yet, the implementation of individual ERAS protocol elements is not sufficient. This approach requires the creation of a multidisciplinary work team, systematic recording of data and the use of the information recorded to implement a cycle of continuous improvement. Since 2015, 1331 patients have been recorded by Hospital Italiano de Buenos Aires. Median length of hospital stay was 4 days and median readmission rate was 7.3%. The overall adherence to the protocol elements was 56% (88% in the preoperative period, 60% in the intraoperative period and 39% in the postope rative period) There was a linear and inverse correlation between the adherence to the program and length of hospitalization for the most common surgical procedures, with an average decrease of one day of hospitalization for each 10% increase in adherence with the program for the most common sur gical procedures. Despite these results, we have encountered difficulties in the data recording systems limiting the implementation of the cycle of continuous improvement. The creation of a multidiscipli nary team, with fluent and efficient communication, is essential for the implementation of an ERAS® program capable of reducing length of hospital stay, morbidity and readmission rates.

Protocol for extended antibiotic therapy after laparoscopic cholecystectomy for acute calculous cholecystitis (Cholecystectomy Antibiotic Randomised Trial, CHART).

INTRODUCTION: Acute calculous cholecystitis represents one of the most common complications of cholelithiasis. While laparoscopic cholecystectomy is the standard treatment in mild and moderate forms, the need for antibiotic therapy after surgery remains undefined. The aim of the randomised controlled Cholecystectomy Antibiotic Randomised Trial (CHART) is therefore to assess if there are benefits in the use of postoperative antibiotics in patients with mild or moderate acute cholecystitis in whom a laparoscopic cholecystectomy is performed. METHODS AND ANALYSIS: A single-centre, double-blind, randomised trial. After screening for eligibility and informed consent, 300 patients admitted for acute calculus cholecystitis will be randomised into two groups of treatment, either receiving amoxicillin/clavulanic acid or placebo for 5 consecutive days. Postoperative evaluation will take place during the first 30 days. Postoperative infectious complications are the primary end point. Secondary end points are length of hospital stay, readmissions, need of reintervention (percutaneous or surgical reinterventions) and overall mortality. The results of this trial will provide strong evidence to either support or abandon the use of antibiotics after surgery, impacting directly in the incidence of adverse events associated with the use of antibiotics, the emergence of bacterial resistance and treatment costs. ETHICS AND DISSEMINATION: This study and informed consent sheets have been approved by the Research Projects Evaluating Committee (CEPI) of Hospital Italiano de Buenos Aires (protocol N° 2111). RESULTS: The results of the trial will be reported in a peer-reviewed publication. TRIAL REGISTRATION NUMBER: NCT02057679.