Postoperative Diet with an Oligomeric Hyperproteic Normocaloric Supplement versus a Supplement with Immunonutrients in Colorectal Cancer Surgery: Results of a Multicenter, Double-Blind, Randomized Clinical Trial

(1) Background: For normo-nourished colorectal cancer patients, the need for immunonutrients after elective surgery is not known. (2) Methods: Multicenter, randomized, double-blind, phase III clinical trial comparing the postoperative diet with 200 mL oligomeric hyperproteic normocaloric (OHN; experimental arm) supplement vs. 200 mL immunonutritional (IN) (active comparator) supplement twice a day for five days in 151 normo-nourished adult colorectal-resection patients following the multimodal rehabilitation ERAS protocol. The proportions of patients with complications (primary outcome) and those who were readmitted, hospitalized for <7 days, had surgical site infections, or died due to surgical complications (secondary outcome) were compared between the two groups until postoperative day 30. Tolerance to both types of supplement and blood parameters was also assessed until day 5. (3) Results: Mean age was 69.2 and 84 (58.7%) were men. Complications were reported in 41 (28.7%) patients and the incidence did not differ between groups (18 (25%) vs. 23 (32.4%) patients with OHN and IN supplement, respectively; p = 0.328). No significant differences were found for the rest of the variables. (4) Conclusions: IN supplement may not be necessary for the postoperative recovery of colorectal cancer patients under the ERAS regimen and with normal nutritional status at the time of surgery

Predictors of complications and mortality following left colectomy with primary stapled anastomosis for cancer: results of a multicentric study with 1111 patients

Aim: Reports detailing the morbidity–mortality after left colectomy are sparse and do not allow definitive conclusions to be drawn. We aimed to identify risk factors for anastomotic leakage, perioperative mortality and complications following left colectomy for colonic malignancies. Method: We undertook a STROBE-compliant analysis of left colectomies included in a national prospective online database. Forty-two variables were analysed as potential independent risk factors for anastomotic leakage, postoperative morbidity and mortality. Variables were selected using the ‘least absolute shrinkage and selection operator’ (LASSO) method. Results: We analysed 1111 patients. Eight per cent of patients had a leakage and in 80% of them reoperation or surgical drainage was needed. A quarter of patients (24.9%) experienced at least one minor complication. Perioperative mortality was 2%, leakage being responsible for 47.6% of deaths. Obesity (OR 2.8, 95% CI 1.00–7.05, P = 0.04) and total parenteral nutrition (TPN) (OR 3.7, 95% CI 1.58–8.51, P = 0.002) were associated with increased risk of leakage, whereas female patients had a lower risk (OR 0.36, 95% CI 0.18–0.67, P = 0.002). Corticosteroids (P = 0.03) and oral anticoagulants (P = 0.01) doubled the risk of complications, which was lower with hyperlipidaemia (OR 0.3, P = 0.02). Patients on TPN had more complications (OR 4.02, 95% CI 2.03–8.07, P = 0.04) and higher mortality (OR 8.7, 95% CI 1.8–40.9, P = 0.006). Liver disease and advanced age impaired survival, corticosteroids being the strongest predictor of mortality (OR 21.5, P = 0.001). Conclusion: Requirement for TPN was associated with more leaks, complications and mortality. Leakage was presumably responsible for almost half of deaths. Hyperlipidaemia and female gender were associated with lower rates of complications. These findings warrant a better understanding of metabolic status on perioperative outcome after left colectomy

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)

The impact of surgical delay on resectability of colorectal cancer: An international prospective cohort study

AimThe SARS-CoV-2 pandemic has provided a unique opportunity to explore the impact of surgical delays on cancer resectability. This study aimed to compare resectability for colorectal cancer patients undergoing delayed versus non-delayed surgery.MethodsThis was an international prospective cohort study of consecutive colorectal cancer patients with a decision for curative surgery (January-April 2020). Surgical delay was defined as an operation taking place more than 4 weeks after treatment decision, in a patient who did not receive neoadjuvant therapy. A subgroup analysis explored the effects of delay in elective patients only. The impact of longer delays was explored in a sensitivity analysis. The primary outcome was complete resection, defined as curative resection with an R0 margin.ResultsOverall, 5453 patients from 304 hospitals in 47 countries were included, of whom 6.6% (358/5453) did not receive their planned operation. Of the 4304 operated patients without neoadjuvant therapy, 40.5% (1744/4304) were delayed beyond 4 weeks. Delayed patients were more likely to be older, men, more comorbid, have higher body mass index and have rectal cancer and early stage disease. Delayed patients had higher unadjusted rates of complete resection (93.7% vs. 91.9%, P = 0.032) and lower rates of emergency surgery (4.5% vs. 22.5%, P ConclusionOne in 15 colorectal cancer patients did not receive their planned operation during the first wave of COVID-19. Surgical delay did not appear to compromise resectability, raising the hypothesis that any reduction in long-term survival attributable to delays is likely to be due to micro-metastatic disease

Delaying surgery for patients with a previous SARS-CoV-2 infection

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