The pan - COVID - AGICT study. The impact of COVID-19 pandemic on surgically treated pancreatic cancer patients. A multicentric Italian study.

BACKGROUND: In this article we aimed to perform a subgroup analysis using data from the COVID-AGICT study, to investigate the perioperative outcomes of patients undergoing surgery for pancreatic cancers (PC) during the COVID-19 pandemic. METHODS: The primary endpoint of the study was to find out any difference in the tumoral stage of surgically treated PC patients between 2019 and 2020. Surgical and oncological outcomes of the entire cohort of patients were also appraised dividing the entire peri-pandemic period into six three-month timeframes to balance out the comparison between 2019 and 2020. RESULTS: Overall, a total of 1815 patients were surgically treated during 2019 and 2020 in 14 Italian surgical Units. In 2020, the rate of patients treated with an advanced pathological stage was not different compared to 2019 (p = 0.846). During the pandemic, neoadjuvant chemotherapy (NCT) has dropped significantly (6.2% vs 21.4%, p < 0.001) and, for patients who didn't undergo NCT, the latency between diagnosis and surgery was shortened (49.58 ± 37 days vs 77.40 ± 83 days, p < 0.001). During 2020 there was a significant increase in minimally invasive procedures (p < 0.001). The rate of postoperative complication was the same in the two years but during 2020 there was an increase of the medical ones (19% vs 16.1%, p = 0.001). CONCLUSIONS: The post-pandemic dramatic modifications in healthcare provision, in Italy, did not significantly impair the clinical history of PC patients receiving surgical resection. The present study is one of the largest reports available on the argument and may provide the basis for long-term analyses.

Association between patient activation and delayed discharge in elective laparoscopic cholecystectomy: A prospective cohort analysis.

BACKGROUND: Improving patient activation may be an effective way to reduce healthcare costs and improve patient outcomes after surgery. OBJECTIVE: To determine whether preoperative patient activation is associated with delayed discharge (i.e., length of stay >24 h) after elective laparoscopic cholecystectomy. Postoperative symptoms, unscheduled access to healthcare facilities within seven days of surgery, unplanned hospital readmissions, and postoperative complications were analyzed as secondary outcomes. DESIGN: This cohort study was a secondary analysis of the DeDiLaCo study (Delayed Discharge after day-surgery Laparoscopic Cholecystectomy) collecting data of patients undergoing elective laparoscopic cholecystectomy during 2021 in Italy. Data was analyzed from June 2022 to April 2023. SETTING: 90 Italian surgical centers participating in the study. PARTICIPANTS: 4708 adult patients with an instrumental diagnosis of gallbladder disease and undergoing laparoscopic cholecystectomy. Patient activation was assessed using the Italian translation of Patient Activation Measure in the preoperative setting. RESULTS: Of 4532 cases analyzed the median (IQR) Patient Activation Measure score was 80.3 (71.2-92.3). Participants were on average 55.5 years of age and 58.1 % were female. Two groups based on the activation level were created: 270 (6 %) had low activation, and 4262 had high activation. The low activation level was associated with the likelihood of delayed discharge (odds ratio [OR] 1.47, 95 % CI, 1.11-1.95; P = .008), higher symptom burden (OR 1.99, 95 % CI 1.49-2.66, P < .0001), and unplanned healthcare utilization within seven days after hospital discharge (OR 1.85, 95 % CI, 1.29-2.63; P = .001). There was no difference between the high and low activation groups in the incidence of postoperative complications (OR 1.28, 95 % CI, 0.95-1.73; P = .10) and hospital readmission after discharge (OR 0.95, 95 % CI, 0.30-3.05; P = .93). CONCLUSIONS: Our results suggest that patients with low activation have 1.47 times the risk of delayed discharge compared with patients with higher activation, almost twice the risk of the onset of postoperative symptoms, and 1.85 times the risk of unscheduled use of hospital services. Screening for patient activation in the preoperative setting could not only identify patients not suitable for early discharge, but more importantly, help physicians and nurses develop tailored interventions.

Rectal Sparing Approach after preoperative Radio- and/or Chemo-therapy (ReSARCh): a prospective, multicenter, observational study.

BACKGROUND: Rectal-sparing approaches for patients with rectal cancer who achieved a complete or major response following neoadjuvant therapy constitute a paradigm of a potential shift in the management of patients with rectal cancer; however, their role remains controversial. The aim of this study was to investigate the feasibility of rectal-sparing approaches to preserve the rectum without impairing the outcomes. METHODS: This prospective, multicenter, observational study investigated the outcomes of patients with clinical stage II-III mid-low rectal adenocarcinoma treated with any neoadjuvant therapy, and either transanal local excision or watch-and-wait approach, based on tumor response (major or complete) and patient/surgeon choice. The primary endpoint of the study was rectum preservation at a minimum follow-up of 2 years. Secondary endpoints were overall, disease-free, local and distant recurrence-free, and stoma-free survival at 3 years. RESULTS: Of the 178 patients enrolled in 16 centers, 112 (62.9%) were managed with local excision and 66 (37.1%) with watch-and-wait. At a median (interquartile range) follow-up of 36.1 (30.6-45.6) months, the rectum was preserved in 144 (80.9%) patients. The 3-year rectum-sparing, overall survival, disease-free survival, local recurrence-free survival, and distant recurrence-free survival was 80.6% (95% CI 73.9-85.8), 97.6% (95% CI 93.6-99.1), 90.0% (95% CI 84.3-93.7), 94.7% (95% CI 90.1-97.2), and 94.6% (95% CI 89.9-97.2), respectively. The 3-year stoma-free survival was 95.0% (95% CI 89.5-97.6). The 3-year regrowth-free survival in the watch-and-wait group was 71.8% (95% CI 59.9-81.2). CONCLUSIONS: In rectal cancer patients with major or complete clinical response after neoadjuvant therapy, the rectum can be preserved in about 80% of cases, without compromising the outcomes.

A Prospective Cohort Analysis of the Prevalence and Predictive Factors of Delayed Discharge After Laparoscopic Cholecystectomy in Italy: The DeDiLaCo Study.

BACKGROUND: The concept of early discharge ≤24 hours after Laparoscopic Cholecystectomy (LC) is still doubted in Italy. This prospective multicentre study aims to analyze the prevalence of patients undergoing elective LC who experienced a delayed discharge >24 hours in an extensive Italian national database and identify potential limiting factors of early discharge after LC. METHODS: This is a prospective observational multicentre study performed from January 1, 2021 to December 31, 2021 by 90 Italian surgical units. RESULTS: A total of 4664 patients were included in the study. Clinical reasons were found only for 850 patients (37.7%) discharged >24 hours after LC. After excluding patients with nonclinical reasons for delayed discharge >24 hours, 2 groups based on the length of hospitalization were created: the Early group (≤24 h; 2414 patients, 73.9%) and the Delayed group (>24 h; 850 patients, 26.1%). At the multivariate analysis, ASA III class ( P <0.0001), Charlson's Comorbidity Index (P=0.001), history of choledocholithiasis (P=0.03), presence of peritoneal adhesions (P<0.0001), operative time >60 min (P<0.0001), drain placement (P<0.0001), pain ( P =0.001), postoperative vomiting (P=0.001) and complications (P<0.0001) were independent predictors of delayed discharge >24 hours. CONCLUSIONS: The majority of delayed discharges >24 hours after LC in our study were unrelated to the surgery itself. ASA class >II, advanced comorbidity, the presence of peritoneal adhesions, prolonged operative time, and placement of abdominal drainage were intraoperative variables independently associated with failure of early discharge.

Implementation Strategies for Preventing Healthcare-Associated Infections across the Surgical Pathway: An Italian Multisociety Document.

Healthcare-associated infections (HAIs) result in significant patient morbidity and can prolong the duration of the hospital stay, causing high supplementary costs in addition to those already sustained due to the patient's underlying disease. Moreover, bacteria are becoming increasingly resistant to antibiotics, making HAI prevention even more important nowadays. The public health consequences of antimicrobial resistance should be constrained by prevention and control actions, which must be a priority for all health systems of the world at all levels of care. As many HAIs are preventable, they may be considered an important indicator of the quality of patient care and represent an important patient safety issue in healthcare. To share implementation strategies for preventing HAIs in the surgical setting and in all healthcare facilities, an Italian multi-society document was published online in November 2022. This article represents an evidence-based summary of the document.

Ileo-colic lipomatosis complicated by cecum perforation and mimicking acute appendicitis: a case report.

Lipomatosis of the colon is rare in clinical practice although the majority of cases are found incidentally. In rare circumstances, patients may presents with acute complications such as bowel obstruction, intussusception, or perforation. Here we report a case of colonic lipomatosis that present as localized peritonitis mimicking acute appendicitis in a young COVID patient. Sixth case in the literature of intestinal perforation peritonitis in intestinal lipomatosis.

Atraumatic Splenic Rupture in a SARS-CoV-2 Patient: Case Report and Review of Literature.

Splenic rupture in the absence of trauma or previously diagnosed disease is rare. Due to the delay of diagnosis and treatment, this is a potentially life-threatening condition. We report a case of atraumatic splenic rupture in a SARS-CoV-2 patient. This report is of particular interest as it first identifies SARS-CoV-2 infection as a possible cause of spontaneous rupture of the spleen. A 46-year-old Caucasian woman presented at the emergency department pale and sweaty, complaining of syncopal episodes, tachycardia, hypotension, diarrhea, intense abdominal pain, diffuse arthromyalgia, and fever from the day before. RT-PCR was positive for SARS-CoV-2 infection. CT scan demonstrated extensive hemoperitoneum due to rupture of the splenic capsule. The patient required an emergency open splenectomy because of an unresponsive hemorrhagic shock. At the end of the surgery, the patient was relocated to a COVID-19 dedicated facility. COVID-19 is a new disease of which all manifestations are not yet known. Inpatients affected by SARS-CoV-2 infection with abdominal pain and spontaneous splenic rupture should be considered to avoid a delayed diagnosis.

Oral neomycin and bacitracin are effective in preventing surgical site infections in elective colorectal surgery: a multicentre, randomized, parallel, single-blinded trial (COLORAL-1).

Several regimens of oral and intravenous antibiotics (OIVA) have been proposed with contradicting results, and the role of mechanical bowel preparation (MBP) is still controversial. This study aims to assess the effectiveness of oral antibiotic prophylaxis in preventing Surgical Site Infections (SSI) in elective colorectal surgery. In a multicentre trial, we randomized patients undergoing elective colorectal resection surgery, comparing the effectiveness of OIVA versus intravenous antibiotics (IVA) regimens to prevent SSI as the primary outcome (NCT04438655). In addition to intravenous Amoxicillin/Clavulanic, patients in the OIVA group received Oral Neomycin and Bacitracin 24 h before surgery. MBP was administered according to local habits which were not changed for the study. The trial was terminated during the COVID-19 pandemic, as many centers failed to participate as well as the pandemic changed the rules for engaging patients. Two-hundred and four patients were enrolled (100 in the OIVA and 104 in the IVA group); 3 SSIs (3.4%) were registered in the OIVA and 14 (14.4%) in the IVA group (p = 0.010). No difference was observed in terms of anastomotic leak. Multivariable analysis indicated that OIVA reduced the rate of SSI (OR 0.21 / 95% CI 0.06-0.78 / p = 0.019), while BMI is a risk factor of SSI (OR 1.15 / 95% CI 1.01-1.30 p = 0.039). Subgroup analysis indicated that 0/22 patients who underwent OIVA/MBP + vs 13/77 IVA/MBP- experienced an SSI (p = 0.037). The early termination of the study prevents any conclusion regarding the interpretation of the data. Nonetheless, Oral Neomycin/Bacitracin and intravenous beta-lactam/beta-lactamases inhibitors seem to reduce SSI after colorectal resections, although not affecting the anastomotic leak in this trial. The role of MBP requires more investigation.

Appendectomy versus conservative treatment with antibiotics for patients with uncomplicated acute appendicitis: a propensity score-matched analysis of patient-centered outcomes (the ACTUAA prospective multicenter trial).

PURPOSE: The aim of this prospective multicenter study was to compare antibiotic therapy and appendectomy as treatment for patients with uncomplicated appendicitis confirmed by ultrasound and/or computed tomography. METHODS: The study was conducted from January 2017 to January 2018. Data regarding all patients discharged from the participating centers with a diagnosis of uncomplicated appendicitis were collected prospectively. RESULTS: Of the 318 patients enrolled in the study, 27.4% underwent antibiotic-first therapy, and 72.6% underwent appendectomy. The matched group was composed of 87 patients in both study arms. Of the 87 patients available of 1-year follow-up in the antibiotic-first group, 64 (73.6%) did not require appendectomy. The complication-free treatment success in the antibiotic-first group was 64.4%. A statistically significant higher complication-free treatment success was found in the appendectomy group: 81.8% in the pre-matching sample and 83.9% in the post-matching sample. Patients in the antibiotic-first group reported lower VAS scores compared to those treated with an appendectomy, both at discharge (2.0 ± 1.7 vs 3.6 ± 2.3) and at 30-day follow-up (0.3 ± 0.6 vs 2.1 ± 1.7). The mean of the days of absence from work was higher in the appendectomy group (ß 0.63; 95% CI 0.08-1.18). CONCLUSION: Although laparoscopic appendectomy remains the gold standard of treatment for uncomplicated appendicitis, conservative treatment with antibiotics is a safe option in most cases. Approximately 65% of patients treated with antibiotics are symptom-free at 1 year, without increased risk of adverse events should symptoms recur, and better outcomes in terms of less pain and shorter period of absence from work compared to patients undergoing an appendectomy. TRIAL REGISTRATION: Clinicaltrials.gov identifier (NCT number): NCT03080103.

Risk factors for postoperative morbidity following appendectomy in the elderly: a nationwide prospective cohort study.

BACKGROUND: A limited number of studies investigating perioperative risk factors associated with emergency appendectomy in elderly patients have been published to date. Whether older age may be associated with poorer outcomes following appendectomy is still a matter of debate. The primary aim of this study was to determine the predictors of postoperative morbidity following appendectomy in patients aged ≥ 65 years. METHODS: Data regarding all elderly patients who underwent emergency appendectomy from January 2017 to June 2018 admitted 36 Italian surgical departments were prospectively collected and analyzed. Baseline demographics and perioperative variables were evaluated. Uni- and multivariate analyses adjusted for differences between groups were carried out to determine possible predictors of adverse outcomes after appendectomy. RESULTS: Between January 2017 and June 2018, 135 patients aged ≥ 65 years with a diagnosis of AA met the study inclusion criteria. Twenty-six patients (19.3%) were diagnosed with some type of postoperative complication. Decreasing the preoperative hemoglobin level showed a statistically significant association with postoperative complications (OR 0.77, CI 0.61-0.97, P = 0.03). Preoperative creatinine level (P = 0.02, OR 2.04, CI 1.12-3.72), and open appendectomy (P = 0.03, OR 2.67, CI 1.11-6.38) were significantly associated with postoperative morbidity. After adjustment, the only independent predictor of postoperative morbidity was preoperative creatinine level (P = 0.04, OR 2.01, CI 1.05-3.89). CONCLUSIONS: In elderly patients with AA, perioperative risk assessment in the emergency setting must be as accurate as possible to identify modifiable risk factors that can be addressed before surgery, such as preoperative hemoglobin and creatinine levels.

Physiological parameters for Prognosis in Abdominal Sepsis (PIPAS) Study: a WSES observational study.

Background: Timing and adequacy of peritoneal source control are the most important pillars in the management of patients with acute peritonitis. Therefore, early prognostic evaluation of acute peritonitis is paramount to assess the severity and establish a prompt and appropriate treatment. The objectives of this study were to identify clinical and laboratory predictors for in-hospital mortality in patients with acute peritonitis and to develop a warning score system, based on easily recognizable and assessable variables, globally accepted. Methods: This worldwide multicentre observational study included 153 surgical departments across 56 countries over a 4-month study period between February 1, 2018, and May 31, 2018. Results: A total of 3137 patients were included, with 1815 (57.9%) men and 1322 (42.1%) women, with a median age of 47 years (interquartile range [IQR] 28-66). The overall in-hospital mortality rate was 8.9%, with a median length of stay of 6 days (IQR 4-10). Using multivariable logistic regression, independent variables associated with in-hospital mortality were identified: age > 80 years, malignancy, severe cardiovascular disease, severe chronic kidney disease, respiratory rate ≥ 22 breaths/min, systolic blood pressure < 100 mmHg, AVPU responsiveness scale (voice and unresponsive), blood oxygen saturation level (SpO2) < 90% in air, platelet count < 50,000 cells/mm3, and lactate > 4 mmol/l. These variables were used to create the PIPAS Severity Score, a bedside early warning score for patients with acute peritonitis. The overall mortality was 2.9% for patients who had scores of 0-1, 22.7% for those who had scores of 2-3, 46.8% for those who had scores of 4-5, and 86.7% for those who have scores of 7-8. Conclusions: The simple PIPAS Severity Score can be used on a global level and can help clinicians to identify patients at high risk for treatment failure and mortality.

Antibiotic Treatment and Appendectomy for Uncomplicated Acute Appendicitis in Adults and Children: A Systematic Review and Meta-analysis.

OBJECTIVE: The aim of this meta-analysis was to summarize the current available evidence on nonoperative management (NOM) with antibiotics for uncomplicated appendicitis, both in adults and children. SUMMARY BACKGROUND DATA: Although earlier meta-analyses demonstrated that NOM with antibiotics may be an acceptable treatment strategy for patients with uncomplicated appendicitis, evidence is limited by conflicting results. METHODS: Systematic literature search was performed using MEDLINE, the Cochrane Central Register of Controlled Trials, and EMBASE databases for randomized and nonrandomized studies comparing antibiotic therapy (AT) and surgical therapy-appendectomy (ST) for uncomplicated appendicitis. Literature search was completed in August 2018. RESULTS: Twenty studies comparing AT and ST qualified for inclusion in the quantitative synthesis. In total, 3618 patients were allocated to AT (n = 1743) or ST (n = 1875). Higher complication-free treatment success rate (82.3% vs 67.2%; P < 0.00001) and treatment efficacy based on 1-year follow-up rate (93.1% vs 72.6%; P < 0.00001) were reported for ST. Index admission antibiotic treatment failure and rate of recurrence at 1-year follow-up were reported in 8.5% and 19.2% of patients treated with antibiotics, respectively. Rates of complicated appendicitis with peritonitis identified at the time of surgical operation (AT: 21.7% vs ST: 12.8%; P = 0.07) and surgical complications (AT: 12.8% vs ST: 13.6%; P = 0.66) were equivalent. CONCLUSIONS: Antibiotic therapy could represent a feasible treatment option for image-proven uncomplicated appendicitis, although complication-free treatment success rates are higher with ST. There is also evidence that NOM for uncomplicated appendicitis does not statistically increase the perforation rate in adult and pediatric patients receiving antibiotic treatment. NOM with antibiotics may fail during the primary hospitalization in about 8% of cases, and an additional 20% of patients might need a second hospitalization for recurrent appendicitis.

Laparoscopic appendectomy vs antibiotic therapy for acute appendicitis: a propensity score-matched analysis from a multicenter cohort study.

Acute appendicitis (AA) is among the most common causes of acute lower abdominal pain leading patients to the emergency department. Significant debate remains on whether AA should be operated or not. A propensity score-matched analysis was performed in seven Italian Hospitals, with the aim to assess safety and feasibility both nonoperative management with antibiotics (AT) and surgical therapy with appendectomy (ST) for patients with AA. Data regarding all patients discharged from the participating centers with a diagnosis of appendicitis from January 1st, 2014 to December 31st, 2014 were collected retrospectively. Follow-up data were collected from January 1st, 2015 to December 31st, 2016. The complication-free treatment success of AT (53.7%) was significantly inferior to that of ST (86.4%) (P < 0.0001). Patients initially treated with antibiotics reported an index admission AT failure rate of 20.9% and a recurrence rate at 1-year follow-up of 20.3%. No statistically significant difference was found when comparing AT and ST groups for the outcome of interest post-operative complications (13.5 vs 13.6%, P = 0.834). Patients treated with AT were discharged home earlier than patients in the ST group (3.38 ± 1.89 vs 4.84 ± 2.69 days, P < 0.0001). Due to the low rates of complications occurred in the ST group and the high efficacy of the surgical therapy, laparoscopic appendectomy still represents the most effective treatment for patients with AA. AT is associated with shorter hospital stay and faster return to normal activity, and may prevent from appendectomies around 80% of patients who leave the hospital with clinical recovery.

A prospective non-randomized controlled, multicenter trial comparing Appendectomy and Conservative Treatment for Patients with Uncomplicated Acute Appendicitis (the ACTUAA study).

PURPOSE: Acute appendicitis (AA) is among the most common causes of lower abdominal pain and admissions to the emergency department. Over the past 20 years, there has been a renewed interest in the conservative management of uncomplicated AA, and several studies demonstrated that an antibiotic-first strategy is a viable treatment option for uncomplicated AA. The aim of this prospective non-randomized controlled, multicenter trial is to compare antibiotic therapy and emergency appendectomy as treatment for patients with uncomplicated AA confirmed by US and/or CT or MRI scan. METHODS: All adult patients in the age range 18 to 65 years with suspected AA, consecutively admitted to the Surgical Department of the 13 participating Italian Hospitals, will be invited to take part in the study. A multicenter prospective collected registry developed by surgeons, radiologists, and pathologists with expertise in the diagnosis and treatment of uncomplicated acute appendicitis represents the best research method to assess the long-term role of antibiotics in the management of the disease. Comparison will be made between surgical and antibiotic-first approaches to uncomplicated AA through the analysis of the primary outcome measure of complication-free treatment success rate based on 1-year follow-up. Quality of life, length of hospital stay, pain evaluation, and time to return to normal activity will be evaluated as secondary outcome measures. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT03080103.