Association between use of enhanced recovery after surgery protocols and postoperative complications after gastric surgery for cancer (POWER 4): a nationwide, prospective multicentre study.

INTRODUCTION: The effectiveness of the Enhanced Recovery After Surgery (ERAS) protocols in gastric cancer surgery remains controversial. METHODS: Multicentre prospective cohort study of adult patients undergoing surgery for gastric cancer. Adherence with 22 individual components of ERAS pathways were assessed in all patients, regardless of whether they were treated in a self-designed ERAS centre. Each centre had a three-month recruitment period between October 2019 and September 2020. The primary outcome was moderate-to-severe postoperative complications within 30 days after surgery. Secondary outcomes were overall postoperative complications, adherence to the ERAS pathway, 30 day-mortality and hospital length of stay (LOS). RESULTS: A total of 743 patients in 72 Spanish hospitals were included, 211 of them (28.4 %) from self-declared ERAS centres. A total of 245 patients (33 %) experienced postoperative complications, graded as moderate-to-severe complications in 172 patients (23.1 %). There were no differences in the incidence of moderate-to-severe complications (22.3% vs. 23.5%; OR, 0.92 (95% CI, 0.59 to 1.41); P = 0.068), or overall postoperative complications between the self-declared ERAS and non-ERAS groups (33.6% vs. 32.7%; OR, 1.05 (95 % CI, 0.70 to 1.56); P = 0.825). The overall rate of adherence to the ERAS pathway was 52% [IQR 45 to 60]. There were no differences in postoperative outcomes between higher (Q1, > 60 %) and lower (Q4, ≤ 45 %) ERAS adherence quartiles. CONCLUSIONS: Neither the partial application of perioperative ERAS measures nor treatment in self-designated ERAS centres improved postoperative outcomes in patients undergoing gastric surgery for cancer. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03865810.

Actionable Factors Fostering Health Value Generation and Scalability of Prehabilitation: A Prospective Cohort Study.

IMPORTANCE: Prehabilitation has potential for improving surgical outcomes as shown in previous randomized controlled trials. However, a marked efficacy-effectiveness gap is limiting its scalability. Comprehensive analyses of deployment of the intervention in real-life scenarios are required. OBJECTIVE: To assess health outcomes and cost of prehabilitation. DESIGN: Prospective cohort study with a control group built using propensity score-matching techniques. SETTING: Prehabilitation Unit in a tertiary-care university hospital. PARTICIPANTS: Candidates for major digestive, cardiac, thoracic, gynecologic, or urologic surgeries. INTERVENTION: Prehabilitation program, including supervised exercise training, promotion of physical activity, nutritional optimization, and psychological support. MAIN OUTCOMES AND MEASURES: The comprehensive complication index, hospital and intensive care unit length of stay, and hospital costs per patient until 30 days after surgery. Patients were classified by the degree of program completion and level of surgical aggression for sensitivity analysis. RESULTS: The analysis of the entire study group did not show differences in study outcomes between prehabilitation and control groups (n=328 each). The per-protocol analysis, including only patients completing the program (n=112, 34%), showed a reduction in mean hospital stay [9.9 (7.2) vs 12.8 (12.4) days; P =0.035]. Completers undergoing highly aggressive surgeries (n=60) additionally showed reduction in mean intensive care unit stay [2.3 (2.7) vs 3.8 (4.2) days; P =0.021] and generated mean cost savings per patient of €3092 (32% cost reduction) ( P =0.007). Five priority areas for action to enhance service efficiencies were identified. CONCLUSIONS AND RELEVANCE: The study indicates a low rate of completion of the intervention and identifies priority areas for re-design of service delivery to enhance the effectiveness of prehabilitation.

Role of Co-creation for Large-Scale Sustainable Adoption of Digitally Supported Integrated Care: Prehabilitation as Use Case.

Introduction: The efficacy-effectiveness gap constitutes a well-known limitation for adoption of digitally enabled integrated care services. The current report describes the co-creation process undertaken (2016-2021) to deploy a prehabilitation service at Hospital Clínic de Barcelona with the final aim of achieving sustainable adoption and facilitate site transferability. Methods: An implementation research approach with a population-based orientation, combining experience-based co-design and quality improvement methodologies, was applied. We undertook several design-thinking sessions (Oct-Nov 2017, June 2021 and December 2021) to generate and follow-up a work plan fostering service scalability. The implementation process was assessed using the Comprehensive Framework for Implementation Research, leading to the identification of key performance indicators. Discussion: Personalization and modularity of the intervention according to patients' surgical risk were identified as core traits to enhance patients' adherence and value generation. A digitally enabled service workflow, with an adaptive and collaborative case management approach, should combine face-to-face and remotely supervised sessions with intelligent systems for patients' and professionals' decision support. The business model envisages operational costs financed by savings generated by the service. Conclusions: Evidence-based co-creation, combining appropriate methodologies and a structured evaluation framework, was key to address challenges associated with sustainable prehabilitation service adoption, scalability and transferability.

Corrigendum to 'A multicenter analysis of the role of prophylactic transfusion of blood products in patients with cirrhosis and esophageal varices undergoing endoscopic band ligation' [JHEP Reports 6 (2021)].

[This corrects the article DOI: 10.1016/j.jhepr.2021.100363.].

Repeatability and learning effect in the 6MWT in preoperative cancer patients undergoing a prehabilitation program.

OBJECTIVE: The main objective was to assess repeatability and learning effect of the 6-min walk test (6MWT) in a cohort of preoperative cancer patients referred to a prehabilitation program. As a secondary objective, we aimed to identify determinants of improvement in the second test. MATERIALS AND METHODS: Secondary analysis from a large prospective study on the implementation of a multimodal prehabilitation program in a real-life scenario. Eligible patients were assessed at baseline before starting the prehabilitation program. The 6MWT was conducted according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with two tests being performed under identical conditions separated by 30 min. The distance covered (in meters) and the physiological responses (heart rate, oxygen saturation, fatigue, and dyspnea) to each test were recorded and compared. RESULTS: A total of 170 patients (60.9%) were analyzed. Repeatability of the distance covered with the 6MWT was excellent (ICC = 0.98; 95% CI: 0.92-0.99), but a mean increase of + 19.5 m (95% CI: 15.6-23.5 m; p = < .001) in the second test was found, showing a learning effect with limits of agreement between - 31.3 and 70.4 m. Coefficient of variation was 4%. No clinical factor was found to be associated with an improvement in the second test. CONCLUSIONS: The 6MWT showed excellent repeatability in preoperative cancer patients, but a significant learning effect is present. No associated factors with a clinically meaningful improvement in the second test were identified. In light of these findings, two attempts of the 6MWT should be encouraged in this population.

A multicenter analysis of the role of prophylactic transfusion of blood products in patients with cirrhosis and esophageal varices undergoing endoscopic band ligation.

BACKGROUND & AIMS: Prophylactic administration of platelets and fresh frozen plasma (FFP) has been recommended in patients with cirrhosis with low platelets and/or prolonged international normalized ratio (INR) without scientific evidence to support this practice. In this analysis, we evaluated the use of prophylactic administration of blood products in outpatients with cirrhosis undergoing endoscopic band ligation (EBL). METHODS: This is a multicenter retrospective analysis of consecutive EBL procedures in patients with cirrhosis at 4 hospitals in Spain from 01/2010-01/2017. FFP and/or platelet transfusion were given at the discretion of the physician if INR was >1.5 and/or platelet count <50x109/L. Patient demographics, endoscopic findings, bleeding events after EBL, and the use of prophylactic FFP or platelets were recorded. RESULTS: A total of 536 patients underwent 1,472 EBL procedures: 72% male; main etiology HCV and alcohol (72%); median MELD score 11; Child-Pugh A/B/C (59/33/8%). EBL procedures were performed for primary (51%) or secondary (49%) prophylaxis. A median of 2 procedures per patient were performed.1-4 FFP and/or platelets were administered in 41 patients (7.6%). The prophylactic transfusion protocol was followed in 16% and 28% of procedures with high INR and/or low platelets, respectively. Post-EBL bleeding occurred in 26 out of 536 patients (4.8%) and in 33 out of 1,472 procedures (2.2%). Bleeding was due to post-EBL ulcers in 21 patients and due to band dislodgment in 5. In 6 patients, bleeding occurred within 24 hours and in the remaining patients it occurred within 2 weeks after EBL. In those that bled, 7 met criteria for transfusion (2 for FFP and 5 for platelets), of whom only 1 received FFP and 4 received platelets; the remaining 19 patients did not meet criteria for transfusion. There was no association between INR or platelet count and bleeding events. Univariate and multivariate analysis revealed that Child-Pugh and MELD scores were risk factors for post-EBL bleeding. CONCLUSIONS: The incidence of post-EBL bleeding is low and is associated with advanced liver disease. Post-EBL bleeding was not related to baseline INR/platelet count and most outpatients with post-EBL bleeding did not meet criteria for prophylactic transfusion. LAY SUMMARY: Patients with chronic liver disease or cirrhosis and enlarged veins (varices) of the esophagus that can potentially bleed commonly need an endoscopy to treat these varices with elastic rubber bands (endoscopic band ligation). Some patients have low platelet counts or prolonged coagulation tests. This analysis of 4 centers evaluated the use of prophylactic administration of blood products in outpatients with cirrhosis undergoing endoscopic band ligation. The results showed that bleeding after band ligation is uncommon and that if bleeding occurs it does not seem to be related with coagulation tests or the administration of blood products to prevent bleeding after band ligation of esophageal varices.

Computerized tests to evaluate recovery of cognitive function after deep sedation with propofol and remifentanil for colonoscopy.

The use of sedation for diagnostic procedures including gastrointestinal endoscopy is rapidly growing. Recovery of cognitive function after sedation is important because it would be important for most patients to resume safe, normal life soon after the procedure. Computerized tests have shown being accurate descriptors of cognitive function. The purpose of the present study was to evaluate the time course of cognitive function recovery after sedation with propofol and remifentanil. A prospective observational double blind clinical study conducted in 34 young healthy adults undergoing elective outpatient colonoscopy under sedation with the combination of propofol and remifentanil using a target controlled infusion system. Cognitive function was measured using a validated battery of computerized cognitive tests (Cogstate™, Melbourne, Australia) at different predefined times: prior to starting sedation (Tbaseline), and then 10 min (T10), 40 min (T40) and 120 min (T120) after the end of colonoscopy. Tests included the assessment of psychomotor function, attention, visual memory and working memory. All colonoscopies were completed (median time: 26 min) without significant adverse events. Patients received a median total dose of propofol and remifentanil of 149 mg and 98 µg, respectively. Psychomotor function and attention declined at T10 but were back to baseline values at T40 for all patients. The magnitude of psychomotor task reduction was large (d = 0.81) however 100% of patients were recovered at T40. Memory related tasks were not affected 10 min after ending sedation. Cognitive impairment in attention and psychomotor function after propofol and remifentanil sedation was significant and large and could be easily detected by computerized cognitive tests. Even though, patients were fully recovered 40 min after ending the procedure. From a cognitive recovery point of view, larger studies should be undertaken to propose adequate criteria for discharge after sedation.

Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial.

OBJECTIVE: The aim of this study was to assess the impact of personalized prehabilitation on postoperative complications in high-risk patients undergoing elective major abdominal surgery. SUMMARY BACKGROUND DATA: Prehabilitation, including endurance exercise training and promotion of physical activity, in patients undergoing major abdominal surgery has been postulated as an effective preventive intervention to reduce postoperative complications. However, the existing studies provide controversial results and show a clear bias toward low-risk patients. METHODS: This was a randomized blinded controlled trial. Eligible candidates accepting to participate were blindly randomized (1:1 ratio) to control (standard care) or intervention (standard care + prehabilitation) groups. Inclusion criteria were: i) age >70 years; and/or, ii) American Society of Anesthesiologists score III/IV. Prehabilitation covered 3 actions: i) motivational interview; ii) high-intensity endurance training; and promotion of physical activity. The main study outcome was the proportion of patients suffering postoperative complications. Secondary outcomes included the endurance time (ET) during cycle-ergometer exercise. RESULTS: We randomized 71 patients to the control arm and 73 to intervention. After excluding 19 patients because of changes in the surgical plan, 63 controls and 62 intervention patients were included in the intention-to-treat analysis. The intervention group enhanced aerobic capacity [ΔET 135 (218) %; P < 0.001), reduced the number of patients with postoperative complications by 51% (relative risk 0.5; 95% confidence interval, 0.3-0.8; P = 0.001) and the rate of complications [1.4 (1.6) and 0.5 (1.0) (P =  0.001)] as compared with controls. CONCLUSION: Prehabilitation enhanced postoperative clinical outcomes in high-risk candidates for elective major abdominal surgery, which can be explained by the increased aerobic capacity.