INDURG TRIAL Protocol: A Randomized Controlled Trial Using Indocyanine Green during Cholecystectomy in Acute Cholecystitis.

INTRODUCTION: Laparoscopic cholecystectomy is one of the most common gastrointestinal surgeries, and bile duct injury is one of its main complications. The use of real-time indocyanine green fluorescence cholangiography allows the identification of extrahepatic biliary structures, facilitating the procedure and reducing the risk of bile duct lesions. A better visualization of the bile duct may help to reduce the need for conversion to open surgery, and may also shorten operating time. The main objective of this study was to determine whether the use of indocyanine green is associated with a reduction in operating time in emergency cholecystectomies. Secondary outcomes are the postoperative hospital stay, the correct intraoperative visualization of the Calot's Triangle structures with the administration of indocyanine green, and the intraoperative complications, postoperative complications and morbidity according to the Clavien-Dindo classification. METHODS: This is a randomized, prospective, controlled, multicenter trial with patients diagnosed with acute cholecystitis requiring emergency cholecystectomy. The control group will comprise 220 patients undergoing emergency laparoscopic cholecystectomy applying the standard technique. The intervention group will comprise 220 patients also undergoing emergency laparoscopic cholecystectomy for acute cholecystitis with prior administration of indocyanine green. CONCLUSION: Due to the lack of published studies on ICG in emergency laparoscopic cholecystectomy, this study may help to establish procedures for its use in the emergency setting.

Microbiological etiology and current resistance patterns in acute calculous cholecystitis.

INTRODUCTION: The current treatment for acute calculous cholecystitis (ACC) is early laparoscopic cholecystectomy, in association with appropriate empiric antibiotic therapy. In our country, the evolution of the prevalence of the germs involved and their resistance patterns have been scarcely described. The aim of the study was to analyze the bacterial etiology and the antibiotic resistance patterns in ACC. METHODS: We conducted a single-center, retrospective, observational study of consecutive patients diagnosed with ACC between 01/2012 and 09/2019. Patients with a concomitant diagnosis of pancreatitis, cholangitis, postoperative cholecystitis, histology of chronic cholecystitis or carcinoma were excluded. Demographic, clinical, therapeutic and microbiological variables were collected, including preoperative blood cultures, bile and peritoneal fluid cultures. RESULTS: A total of 1104 ACC were identified, and samples were taken from 830 patients: bile in 89%, peritoneal fluid and/or blood cultures in 25%. Half of the bile cultures and less than one-third of the blood and/or peritoneum samples were positive. Escherichia coli (36%), Enterococcus spp (25%), Klebsiella spp (21%), Streptococcus spp (17%), Enterobacter spp (14%) and Citrobacter spp (7%) were isolated. Anaerobes were identified in 7% of patients and Candida spp in 1%. Nearly 37% of patients received inadequate empirical antibiotic therapy. Resistance patterns were scrutinized for each bacterial species. The main causes of inappropriateness were extended-spectrum beta-lactamase-producing bacteria (34%) and Enterococcus spp (45%), especially in patients older than 80 years. CONCLUSIONS: Updated knowledge of microbiology and resistance patterns in our setting is essential to readjust empirical antibiotic therapy and ACC treatment protocols.

Impact of empiric antibiotic therapy on the clinical outcome of acute calculous cholecystitis.

PURPOSE: Although mortality and morbidity of severe acute calculous cholecystitis (ACC) are still a matter of concern, the impact of inadequate empirical antibiotic therapy has been poorly studied as a risk factor. The objective was to assess the impact of the adequacy of empirical antibiotic therapy on complication and mortality rates in ACC. METHODS: This observational retrospective cohort chart-based single-center study was conducted between 2012 and 2016. A total of 963 consecutive patients were included, and pure ACC was selected. General, clinical, postoperative, and microbiological variables were collected, and risk factors and consequences of inadequate treatment were analyzed. RESULTS: Bile, blood, and/or exudate cultures were obtained in 76.3% of patients, more often in old, male, and severely ill patients (P < 0.001). Patients who were cultured had a higher overall rate of postoperative complications (47.4% vs. 29.7%; P < 0.001), as well as of severe complications (11.6% vs. 4.7%; P = 0.008). Patients with positive cultures had more overall complications (54.8% vs. 39.6%; P = 0.001), more severe complications (16.3% vs. 6.7%; P = 0.001), and higher mortality rates (6% vs. 1.9%; P = 0.012). Patients who received inadequate empirical antibiotic therapy had a fourfold higher mortality rate than those receiving adequate therapy (n = 283; 12.8% vs. 3.4%; P = 0.003). This association was especially marked in severe ACC TG-III patients (n = 132; 18.2 vs. 5.1%; P = 0.018) and remained a predictor of mortality in a binary logistic regression (OR 4.4; 95% CI 1.3-15.3). CONCLUSION: Patients with positive cultures developed more complications and faced higher mortality. Adequate empirical antibiotic therapy appears to be of paramount importance in ACC, particularly in severely ill patients.

Risk factors for complications in acute calculous cholecystitis. Deconstruction of the Tokyo Guidelines.

OBJECTIVE: To challenge the risk factors described in Tokyo Guidelines in Acute Calculous Cholecystitis. METHODS: Retrospective single center cohort study with 963 patients with Acute Cholecystitis during a period of 5 years. Some 725 patients with a "pure" Acute Calculous Cholecystitis were selected. The analysis included 166 variables encompassing all risk factors described in Tokyo Guidelines. The Propensity Score Matching method selected two subgroups of patients with equal comorbidities, to compare the severe complications rate according to the initial treatment (Surgical vs Non-Surgical). We analyzed the Failure-to-rescue as a quality indicator in the treatment of Acute Calculous Cholecystitis. RESULTS: the median age was 69 years (IQR 53-80). 85.1% of the patients were ASA II or III. The grade of the Acute Calculous Cholecystitis was mild in a 21%, moderate in 39% and severe in 40% of the patients. Cholecystectomy was performed in 95% of the patients. The overall complications rate was 43% and the mortality was 3.6%. The Logistic Regression model isolated 3 risk factor for severe complication: ASA > II, cancer without metastases and moderate to severe renal disease. The Failure-to-Rescue (8%) was higher in patients with non-surgical treatment (32% vs. 7%; P = 0.002). After Propensity Score Matching, the number of severe complications was similar between Surgical and Non-Surgical treatment groups (48.5% vs 62.5%; P = 0.21). CONCLUSIONS: the recommended treatment for Acute Calculous Cholecystitis is the Laparoscopic Cholecystectomy. Only three risk factors from the Tokyo Guidelines list appeared as independent predictors of severe complications. The failure-to-rescue is higher in non-surgically treated patients.

Scientific evidence of the duration of antibiotic treatment in intra-abdominal infections with surgical focus control.

A non-systematic review of the published scientific evidence has been carried out on the duration of empirical antibiotic treatment in surgical intra-abdominal infections (IIA) with effective focus control. Given the progressive increase in antibiotic resistance, it is urgent to have strategies to reduce the pressure on the microbiota. The American guidelines made by Mazuski et al. of 20171, as the central axis in the recommendations of the duration of empirical antibiotic treatment in intra-abdominal infections with control of the focus and a bibliographic search of all the articles that contained the keywords in Pubmed and Google Scholar is added. 21 articles referring to the duration of empirical antibiotic treatment in intra-abdominal infection with control of the focus are collected. With the American guidelines and these articles, a proposal is prepared for the duration of empirical antibiotic treatment in patients without risk factors between 24 and 72 h. And in those who present risk factors, it should be individualized with active monitoring every 24 h of fever, paralytic ileus and leukocytosis (FIL), before an early detection of complications or the need for changes in antibiotic treatment. Short treatments are just as effective as those of longer durations and are associated with fewer adverse effects, therefore, daily adjusting and reassessing the duration of empirical antibiotic treatment is essential for better practice.

Mortality risk estimation in acute calculous cholecystitis: beyond the Tokyo Guidelines.

BACKGROUND: Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is the early laparoscopic cholecystectomy; however, the Tokyo Guidelines (TG) advocate for different initial treatments in some subgroups of patients without a strong evidence that all patients will benefit from them. There is no clear consensus in the literature about who is the unfit patient for surgical treatment. The primary aim of the study is to identify the risk factors for mortality in ACC and compare them with Tokyo Guidelines (TG) classification. METHODS: Retrospective unicentric cohort study of patients emergently admitted with and ACC during 1 January 2011 to 31 December 2016. The study comprised 963 patients. Primary outcome was the mortality after the diagnosis. A propensity score method was used to avoid confounding factors comparing surgical treatment and non-surgical treatment. RESULTS: The overall mortality was 3.6%. Mortality was associated with older age (68 + IQR 27 vs. 83 + IQR 5.5; P = 0.001) and higher Charlson Comorbidity Index (3.5 + 5.3 vs. 0+2; P = 0.001). A logistic regression model isolated four mortality risk factors (ACME): chronic obstructive pulmonary disease (OR 4.66 95% CI 1.7-12.8 P = 0.001), dementia (OR 4.12; 95% CI 1.34-12.7, P = 0.001), age > 80 years (OR 1.12: 95% CI 1.02-1.21, P = 0.001) and the need of preoperative vasoactive amines (OR 9.9: 95% CI 3.5-28.3, P = 0.001) which predicted the mortality in a 92% of the patients. The receiver operating characteristic curve yielded an area of 88% significantly higher that 68% (P = 0.003) from the TG classification. When comparing subgroups selected using propensity score matching with the same morbidity and severity of ACC, mortality was higher in the non-surgical treatment group. (26.2% vs. 10.5%). CONCLUSIONS: Mortality was higher in ACC patients treated with non-surgical treatment. ACME identifies high-risk patients. The validation to ACME with a prospective multicenter study population could allow us to create a new alternative guideline to TG for treating ACC. TRIAL REGISTRATION: Retrospectively registered and recorded in Clinical Trials. NCT04744441.

Pancreas sparing duodenectomy in the treatment of primary duodenal neoplasms and other situations with duodenal involvement.

BACKGROUND: There are no clearly defined indications for pancreas-preserving duodenectomy. The present study aimed to analyze postoperative morbidity and the outcomes of patients undergoing pancreas-preserving duodenectomy. METHODS: Patients undergoing pancreas-preserving duodenectomy from April 2008 to May 2020 were included. We divided the series according to indication: scenario 1, primary duodenal tumors; scenario 2, tumors of another origin with duodenal involvement; and scenario 3, emergency duodenectomy. RESULTS: We included 35 patients. Total duodenectomy was performed in 1 patient of adenomatous duodenal polyposis, limited duodenectomy in 7, and third + fourth duodenal portion resection in 27. The indications for scenario 1 were gastrointestinal stromal tumor (n = 13), adenocarcinoma (n = 4), neuroendocrine tumor (n = 3), duodenal adenoma (n = 1), and adenomatous duodenal polyposis (n = 1); scenario 2: retroperitoneal desmoid tumor (n = 2), recurrence of liposarcoma (n = 2), retroperitoneal paraganglioma (n = 1), neuroendocrine tumor in pancreatic uncinate process (n = 1), and duodenal infiltration due to metastatic adenopathies of a germinal tumor with digestive hemorrhage (n = 1); and scenario 3: aortoenteric fistula (n = 3), duodenal trauma (n = 1), erosive duodenitis (n = 1), and biliopancreatic limb ischemia (n = 1). Severe complications (Clavien-Dindo ≥ IIIb) developed in 14% (5/35), and postoperative mortality was 3% (1/35). CONCLUSIONS: Pancreas-preserving duodenectomy is useful in the management of primary duodenal tumors, and is a technical option for some tumors with duodenal infiltration or in emergency interventions.

Efficacy and Safety of Delayed Prolonged-Release Tacrolimus Initiation in De Novo Hepatitis C Virus-Negative Orthotopic Liver Transplant Recipients: A Single-Center, Single-Arm, Prospective Study.

BACKGROUND Delaying initiation of tacrolimus after liver transplantation (LT) is a potential renal-sparing strategy. We assessed safety and efficacy of delayed initiation of prolonged-release tacrolimus (PR-T) in de novo LT. MATERIAL AND METHODS This was a single-center, single-arm, prospective, 12-month observational study of hepatitis C virus-negative orthotopic LT patients. Immunosuppression included PR-T (initially 0.1 or 0.2 mg/kg/day) initiated on Day 3 post LT, basiliximab (20 mg) on post-transplantation Day 0 and Day 4, and intraoperative corticosteroids (500 mg). Patients received maintenance corticosteroids and mycophenolate mofetil (MMF) according to center protocol. MMF dose was adjusted according to thrombocyte count. The primary endpoint was the estimated glomerular filtration rate (eGFR) measured using the Modification of Diet in Renal Disease 4-variable formula at 12 months. Secondary endpoints included biopsy-confirmed acute rejection (BCAR) and dialysis requirement. Adverse events were recorded. RESULTS Sixty-nine patients (mean age 55.0 years) were included. Most patients started MMF on Day 1 (60.9%) or Day 2 (10.1%), and PR-T on Day 3 (55.1%) or Day 4 (29.0%). Mean tacrolimus trough levels (ng/mL) were: Day 7, 9.5±6.3; Day 10, 9.4±5.4; Month 1, 8.0±3.1; Month 3, 7.8±3.7; Month 6, 8.0±4.1; and Month 12, 7.2±3.1. Mean 12-month eGFR was 77.2±24.5 mL/min/1.73 m2; 72.5% of patients had eGFR >60 mL/min/1.73 m² at 12 months; 89.9% had no eGFR measurements <40 mL/min/1.73 m² during the study. Renal insufficiency (any eGFR <60 mL/min/1.73 m²) was diagnosed in 27.5% of patients; one patient required dialysis. There were no BCAR episodes; the infection rate was 36.2%, and 3 patients died. Overall, 19 patients (27.5%) developed de novo diabetes mellitus, 18 patients (26.1%) had hypercholesterolemia, and 12 patients (17.4%) had hypertriglyceridemia. CONCLUSIONS Quadruple therapy with delayed administration of PR-T was well tolerated and efficacious, and was associated with acceptable renal function over 12 months.

Variations in vascular anatomy and unilateral adrenal agenesis in a female cadaver with situs inversus totalis.

PURPOSE: Situs inversus totalis is mirror transposition of thoracic and abdominal organs. Very few reports have been published on anatomic dissections of cadavers with this condition. METHODS: This work describes a case of situs inversus totalis identified during the anatomical dissection of a 91-year-old woman. RESULTS: Thoracic and abdominal viscera were inverted, but otherwise normal. The aorta originated from the right ventricle, which exhibited characteristics of the systemic ventricle. The pulmonary artery originated from the left ventricle, which had a tricuspid valve, three papillary muscles, thick trabeculae, a supraventricular crest, and septomarginal trabecula. The atrial situs was concordant with ventricular morphology. Lungs and paranasal sinuses were not suggestive of Kartagener's syndrome. Only the right adrenal gland was present, and variations in vascular anatomy were observed. The latter included: the celiac trunk branching into a phrenic artery, the splenic artery and a right gastric artery; the common hepatic artery originating from the superior mesenteric artery; and, on the left side, two inferior thyroid arteries, both originating from thyrocervical trunk. The occurrence of a double inferior thyroid artery and agenesis of adrenal gland was never communicated in situs inversus. Embryonic origin of celiac trunk and superior mesenteric artery variations could be explained by the separation at higher levels of the longitudinal anastomoses formed between the four roots of omphalomesenteric artery. CONCLUSION: It can be hypothesized that this phenomenon could occur more frequently in situs inversus than in situs solitus. However, the number of cases investigated in such detail is too small to draw firm conclusions.

Pelvic exenteration with rectal resection for different types of malignancies at two tertiary referral centres. / Exenteración pélvica con resección rectal por neoplasias de distinto origen en dos centros de referencia.

INTRODUCTION: Pelvic exenteration (PE) offers the best chance of cure for locally advanced primary or recurrent pelvic organ malignancies invading adjacent organs. The aims of this study were to analyse results for any pelvic exenteration that includes rectal resection and the analysis of results of fecal and urinary reconstruction. METHOD: From January 2000 to April 2014, 111 PE with rectal resection for any pelvic cancer were analysed retrospectively at two national tertiary referral centers. RESULTS: Thirty-six colorectal anastomosis were performed. Urologic reconstructions performed were 30 double barrelled wet colostomy (DBWC), 14 Bricker ileal conduit (BIC), and 2 ureterocutaneostomies. Postoperative complications occurred in 71 patients (64%). Six deaths (5.4%) occurred within 30 postoperative days. Five-year overall survival following R0 resection was 62.6%; R1: 42.7%; R2: 24.2% (P=.018). The resection margin status was associated with overall survival, local recurrence and distant recurrence. CONCLUSION: Pelvic exenterations for any cause need to be performed in referral centers and by specialized surgeons. Anastomosis after modified supralevator pelvic exenteration for ovarian cancer, is safe. DBWC can be considered a valid option for urologic reconstruction. The most important prognostic factor after pelvic exenteration for malignant pelvic tumors is the status of surgical margins.

Results of surgery for pelvic recurrence of rectal cancer. Experience in a referral center. / Resultados de la cirugía de la recidiva pélvica de cáncer de recto. Experiencia en un centro de referencia.

INTRODUCTION: The only curative treatment of pelvic recurrence of rectal cancer is radical resection. The aim of this paper is to analyze our experience in surgery for local recurrence of rectal cancer. METHODS: We performed a descriptive retrospective analysis of patients treated with curative intent for local recurrence of rectal cancer from May 2000 to January 2014. The presence of resectable liver or lung metastases was not an exclusion criterion. The descriptive results, overall survival and disease free survival are presented. RESULTS: A total of 35 patients were included. In 18 patients an abdomino-perineal resection of the remaining rectum was performed. Two of them included excision of lower sacral vertebrae, while in 17 patients, sphincter sparing surgery was performed. The most frequent postoperative complications were pelvic collection and postoperative ileus. Seven patients required reoperation and one patient died. Overall survival at one year was 91.2%, at 2 years 75.6% and at 5 years 37%. CONCLUSIONS: Local recurrence of rectal cancer is a disease with high curability rate. The only curative option is radical surgery, with acceptable mortality.