Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

P206 EVALUATION OF PREEMPTIVE MULTIMODAL ANALGESIA IN IVOR LEWIS ESOPHAGECTOMY

Abstract Aim of the study is the evaluation of preemptive multimodal analgesia vs established technique of single epidural, in Ivor Lewis esophagectomy, perioperatively. Background &amp; Methods In a randomized prospective trial, 25 patients were randomly assigned to two groups (A=12: preemptive multimodal analgesia, and B=13: epidural analgesia) after informed consent. Patients with coagulative disorders, and renal or hepatic impairment were excluded from study. In all patients a thoracic epidural (T5 – T7) was placed before anesthesia induction. Anesthetic protocol was the same, according body weight, in both groups, apart from analgesic drugs. Group A patients received morphine 1.5-3mg and ropivacaine 0.25% 10-12 ml epidurally (ed), and paracetamol 1gr, parecoxib 40mg, clonidine 150mcg, dexamethasone 8mg, lidocaine 1mg/kg, and magnesium sulfate 25% 10 ml iv, at least 20 min before surgical incision, while in group B same doses of ed morphine and ropivacaine were administered post-incision and iv paracetamol and parecoxib were administered 1hr before end of surgery. Surgical incision infiltration in both wounds with ropivacaine 0.375% 20ml was performed jn both groups’ patients. Intraoperative opioid doses were titrated accordingly. Analgesic needs intra- and postoperatively, as well as vital signs stability and side effects such as postoperative nausea or vomiting (PONV), dizziness, sleepiness, and respiratory suppression were recorded. Results Group A patients received significantly lower opioid doses intraoperatively (p&lt;0.001), 2 (17%) of them did not need extra opioids at all, and in 8 (67%), operation was completed with only one low dose of fentanyl (2-3mcg/kg) before abdominal surgical incision. Group A patients had stable heart rate (HR) and blood pressure (BP) during whole operation, while 11 (84.6%) from group B (p&lt;0.001) demonstrated HR and BP raising in certain surgical times. All both groups’ patients were transferred to ICU awake. 5 (38.46%) group B patients (p&gt;0.005) required rescue amalgesic post-awakening. None of both groups’patients demonstrated any drugs’ side effects. Conclusion Preemptive multimodal analgesia seems to be more efficient, reducing needs for opioids intraoperatively, rescue analgesics postoperatively and providing better hemodynamic stability, than single epidural. Further studies are needed to support this conclusion. </jats:sec

P207 COMPARISON OF OPIOID vs OPIOID PLUS LOCAL ANESTHETIC EPIDURAL ADMINISTRATION IN IVOR LEWIS ESOPHAGECTOMY

Abstract Aim of the study was the comparison of single morphine vs morphine plus ropivacaine epidural administration for intraoperative pain management in Ivor Lewis esophagectomy. Background &amp; Methods In a randomized prospective clinical trial, after informed consent, 20 patients were assigned to groups A (n=10): Morphine, and B (n=10=): Morphine and ropivacaine combination, according to the medication they were administered epidurally (ed), when submitted to Ivor Lewis esophagectomy. In both groups’ patients a thoracic epidural (T5-7) was inserted preoperative, and anesthetic protocol was the same, apart from opioid analgesics, that were titrated according to patients’ requirements. In group A morphine 1.5-3mg in 10-12ml normal saline volume, while in group B morphine 1.5-3mg plus ropivacaine 0.25% in a total volume of 10-12 ml were ed administered at least 20min before surgical incision. Opioids requirement, heart rate, arterial blood pressure, increments of muscle relaxant (rocuronium bromide) repetitive doses intraoperatively, and rescue analgesics need and side effects such as nausea, vomiting, drowsiness, respiratory depression and patients’distress in case of leg movement inability were recorded postoperatively. Results Patients’ demographics were similar in both groups. Intraoperatively, group A received significantly higher (p&lt;0.001) fentanyl doses (4-6mcg/kg initially and 2hrs repetitive increments of 1-2mcg) vs group B (2-2.5mcg/kg initially, 4 (40%) patients didn’t require any supplementary dose and the rest 2-3mcg/kg in 1-2 increment doses until the end of operation). Vital signs were stable in both groups. Rocuronium requirement was significantly lower (p&lt;0.001) in group B (apart from initial dose 1mg/kg, which was the same in both groups, group B demanded repetitive dose only before single to two-lumen endotracheal tube replacement, while group A required 0.2-0.3mg increment doses hourly). All patients were transferred awake postoperatively in ICU. None of any group patients demonstrated any side effects, but 3 (30%) group A patients required rescue analgesic (pain score &gt; 4). Conclusion Morphine plus ropivacaine combination administered epidurally seems to provide lower pain scores and reduces the need for extra opioids intra- and postoperatively, and reduces muscle relaxants requirement during operation. Further studies are required to support these findings. </jats:sec

“High risk” HPV types are frequently detected in potentially malignant and malignant oral lesions, but not in normal oral mucosa

Studies on the involvement of the human papillomavirus (HPV) in initiation and progression of oral neoplasia have generated conflicting results. The observed discrepancy is attributable mainly to the varying sensitivity of the applied methodologies and to epidemiologic factors of the examined patient groups. To evaluate the role of HPV in oral carcinogenesis, we analyzed 53 potentially neoplastic and neoplastic oral lesions consisting of 29 cases of hyperplasia, 5 cases of dysplasia, and 19 cases of squamous cell carcinomas, as well as 16 oral specimens derived from healthy individuals. A highly sensitive nested polymerase chain reaction (PCR) assay was used, along with type-specific PCR, restriction fragment length polymorphism analysis, dot blotting, and nonisotopic in situ hybridization. Nested PCR revealed the presence of HPV DNA in 48 of the 53 (91%) pathologic samples analyzed, whereas none (0%) of the normal specimens was found to be infected. Positivity for HPV was independent of histology and the smoking habits of the analyzed group of patients. At least one “high risk” type, such as HPV 16, 18, and 33, was detected by type-specific PCR in 47 (98%) infected specimens, whereas only 1 (2%) squamous cell carcinoma was solely infected by a “low risk” type (HPV 6). HPV 16 was the prevailing viral type, being present in 71% of infected cases. Single HPV 16 and HPV 18 infections were confirmed by restriction fragment length polymorphism. HPV 58 was detected by dot blotting in three hyperplastic lesions. HPV positivity and genotyping were further confirmed, and the physical status of this virus was evaluated by nonisotopic in situ hybridization. Diffuse and punctate signals, indicative of the episomal and integrative pattern of HPV infection, were observed for low- and high-risk types, respectively. Our findings are suggestive of an early involvement of high-risk HPV types in oral carcinogenesis

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background: Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods: The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results: A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion: Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P &lt; 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)