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1.
BMJ Open ; 11(6): e047491, 2021 06 03.
Article in English | MEDLINE | ID: covidwho-1261190

ABSTRACT

INTRODUCTION: The ERAS protocol (Enhanced Recovery After Surgery) is a multimodal pathway aimed to reduce surgical stress and to allow a rapid postoperative recovery. Application of the ERAS protocol to colorectal cancer surgery has been limited to a minority of hospitals in Italy. To promote the systematic adoption of ERAS in the entire regional hospital network in Piemonte an Audit and Feedback approach (A&F) has been adopted together with a cluster randomised trial to estimate the true impact of the protocol on a large, unselected population. METHODS: A multicentre stepped wedge cluster randomised trial is designed for comparison between standard perioperative management and the management according to the ERAS protocol. The primary outcome is the length of hospital stay (LOS). Secondary outcomes are: incidence of postoperative complications, time to patients' recovery, control of pain and patients' satisfaction. With an A&F approach the adherence to the ERAS items is monitored through a dedicated area in the study web site. The study includes 28 surgical centres, stratified by activity volume and randomly divided into four groups. Each group is randomly assigned to a different activation period of the ERAS protocol. There are four activation periods, one every 3 months. However, the planned calendar and the total duration of the study have been extended by 6 months due to the COVID-19 pandemic.The expected sample size of about 2200 patients has a high statistical power (98%) to detect a reduction of LOS of 1 day and to estimate clinically meaningful changes in the other endpoints. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethical Committee of the coordinating centre and by all participating centres. Study results will be timely circulated within the hospital network and published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT04037787.


Subject(s)
COVID-19 , Colorectal Neoplasms , Enhanced Recovery After Surgery , Colorectal Neoplasms/surgery , Feedback , Humans , Italy , Length of Stay , Multicenter Studies as Topic , Pandemics , Postoperative Complications/epidemiology , Postoperative Complications/prevention & control , Randomized Controlled Trials as Topic , SARS-CoV-2
2.
Updates Surg ; 73(2): 745-752, 2021 Apr.
Article in English | MEDLINE | ID: covidwho-1002181

ABSTRACT

Since the beginning of the pandemic due to the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and its related disease, coronavirus disease 2019 (COVID-19), several articles reported negative outcomes in surgery of infected patients. Aim of this study is to report results of patients with COVID-19-positive swab, in the perioperative period after surgery. Data of COVID-19-positive patients undergoing emergent or oncological surgery, were collected in a retrospective, multicenter study, which involved 20 Italian institutions. Collected parameters were age, sex, body mass index, COVID-19-related symptoms, patients' comorbidities, surgical procedure, personal protection equipment (PPE) used in operating rooms, rate of postoperative infection among healthcare staff and complications, within 30-postoperative days. 68 patients, who underwent surgery, resulted COVID-19-positive in the perioperative period. Symptomatic patients were 63 (92.5%). Fever was the main symptom in 36 (52.9%) patients, followed by dyspnoea (26.5%) and cough (13.2%). We recorded 22 (32%) intensive care unit admissions, 23 (33.8%) postoperative pulmonary complications and 15 (22%) acute respiratory distress syndromes. As regards the ten postoperative deaths (14.7%), 6 cases were related to surgical complications. One surgeon, one scrub nurse and two circulating nurses were infected after surgery due to the lack of specific PPE. We reported less surgery-related pulmonary complications and mortality in Sars-CoV-2-infected patients, than in literature. Emergent and oncological surgery should not be postponed, but it is mandatory to use full PPE, and to adopt preoperative screenings and strategies that mitigate the detrimental effect of pulmonary complications, mostly responsible for mortality.


Subject(s)
COVID-19/complications , COVID-19/epidemiology , Elective Surgical Procedures/mortality , Pneumonia, Viral/complications , Pneumonia, Viral/epidemiology , Postoperative Complications/mortality , Adult , Aged , Aged, 80 and over , COVID-19/transmission , Emergencies , Female , Humans , Infection Control/organization & administration , Italy/epidemiology , Male , Middle Aged , Occupational Exposure/statistics & numerical data , Pandemics , Pneumonia, Viral/transmission , Pneumonia, Viral/virology , Retrospective Studies , Risk Factors , SARS-CoV-2
3.
Dis Esophagus ; 34(6)2021 Jun 14.
Article in English | MEDLINE | ID: covidwho-947651

ABSTRACT

Coronavirus Disease-19 (COVID-19) outbreak has significantly burdened healthcare systems worldwide, leading to reorganization of healthcare services and reallocation of resources. The Italian Society for Study of Esophageal Diseases (SISME) conducted a national survey to evaluate changes in esophageal cancer management in a region severely struck by COVID-19 pandemic. A web-based questionnaire (26 items) was sent to 12 SISME units. Short-term outcomes of esophageal resections performed during the lockdown were compared with those achieved in the same period of 2019. Six (50%) centers had significant restrictions in their activity. However, overall number of resections did not decrease compared to 2019, while a higher rate of open esophageal resections was observed (40 vs. 21.7%; P = 0.034). Surgery was delayed in 24 (36.9%) patients in 6 (50%) centers, mostly due to shortage of anesthesiologists, and occupation of intensive care unit beds from intubated COVID-19 patients. Indications for neoadjuvant chemo (radio) therapy were extended in 14% of patients. Separate COVID-19 hospital pathways were active in 11 (91.7%) units. COVID-19 screening protocols included nasopharyngeal swab in 91.7%, chest computed tomography scan in 8.3% and selective use of lung ultrasound in 75% of units. Postoperative interstitial pneumonia occurred in 1 (1.5%) patient. Recovery from COVID-19 pandemic was characterized by screening of patients in all units, and follow-up outpatient visits in only 33% of units. This survey shows that clinical strategies differed considerably among the 12 SISME centers. Evidence-based guidelines are needed to support the surgical esophageal community and to standardize clinical practice in case of further pandemics.


Subject(s)
COVID-19 , Communicable Disease Control , Digestive System Surgical Procedures/statistics & numerical data , Esophageal Neoplasms , Pandemics , Surgeons/psychology , COVID-19/prevention & control , Disease Outbreaks , Esophageal Neoplasms/epidemiology , Esophageal Neoplasms/surgery , Humans , Italy/epidemiology , SARS-CoV-2
5.
Updates Surg ; 72(2): 249-257, 2020 Jun.
Article in English | MEDLINE | ID: covidwho-324541

ABSTRACT

BACKGROUND: The COVID19 pandemic had a deep impact on healthcare facilities in Italy, with profound reorganization of surgical activities. The Italian ColoRectal Anastomotic Leakage (iCral) study group collecting 43 Italian surgical centers experienced in colorectal surgery from multiple regions performed a quick survey to make a snapshot of the current situation. METHODS: A 25-items questionnaire was sent to the 43 principal investigators of the iCral study group, with questions regarding qualitative and quantitative aspects of the surgical activity before and after the COVID19 outbreak. RESULTS: Two-thirds of the centers were involved in the treatment of COVID19 cases. Intensive care units (ICU) beds were partially or totally reallocated for the treatment of COVID19 cases in 72% of the hospitals. Elective colorectal surgery for malignancy was stopped or delayed in nearly 30% of the centers, with less than 20% of them still scheduling elective colorectal resections for frail and comorbid patients needing postoperative ICU care. A significant reduction of the number of colorectal resections during the time span from January to March 2020 was recorded, with significant delay in treatment in more than 50% of the centers. DISCUSSION: Our survey confirms that COVID19 outbreak is severely affecting the activity of colorectal surgery centers participating to iCral study group. This could impact the activity of surgical centers for many months after the end of the emergency.


Subject(s)
Colon/surgery , Coronavirus Infections/epidemiology , Digestive System Surgical Procedures/statistics & numerical data , Disease Outbreaks , Elective Surgical Procedures/statistics & numerical data , Pneumonia, Viral/epidemiology , Rectum/surgery , COVID-19 , Humans , Italy/epidemiology , Pandemics , Surveys and Questionnaires , Time Factors
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